<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03249454</url>
  </required_header>
  <id_info>
    <org_study_id>HSC-MS-17-0166</org_study_id>
    <nct_id>NCT03249454</nct_id>
  </id_info>
  <brief_title>Effects of Transcutaneous Spinal Direct Current Stimulation in Incomplete Spinal Cord Injury</brief_title>
  <official_title>Effects of Transcutaneous Spinal Direct Current Stimulation in Incomplete Spinal Cord Injury</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The University of Texas Health Science Center, Houston</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>TIRR/Mission Connect</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>The University of Texas Health Science Center, Houston</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_unapproved_device>Yes</is_unapproved_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the study is to investigate the effects of a novel therapeutic approach with&#xD;
      transcutaneous spinal direct current stimulation (tsDCS) to promote functional recovery and&#xD;
      spasticity in chronic spinal cord injury (SCI).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of the study is to investigate the effects of a novel therapeutic approach to&#xD;
      promote functional recovery and spasticity in chronic SCI. The tsDCS effect on&#xD;
      neuro-physiological measures such as H reflex and somatosensory evoked potential (SSEP) wiil&#xD;
      be evaluated in subjects with SCI. This incremental, design will allow the establishment of&#xD;
      strong electrophysiological data prior to rapid clinical translation of the findings about&#xD;
      this promising, early-stage technique.&#xD;
&#xD;
      The central hypothesis is twofold: 1) active tsDCS will lead to a change in Hmax/M max ratio&#xD;
      than sham tsDCS, in a polarity dependent manner; and 2) active tsDCS will lead to a change in&#xD;
      SSEP amplitude and latency, in a polarity dependent manner.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 11, 2017</start_date>
  <completion_date type="Actual">October 26, 2018</completion_date>
  <primary_completion_date type="Actual">October 26, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <intervention_model_description>Crossover design with 9 arms: Anodal tsDCS, Cathodal tsDCS, Sham tsDCS</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percent Change in Hmax</measure>
    <time_frame>10 minutes before intervention, 10 minutes after intervention</time_frame>
    <description>Immediately before application of tsDCS and after application of tsDCS, Hmax will be obtained from soleus muscle by stimulation of tibial nerve. The H-reflex is a compound muscle action potential elicited by low-threshold electrical stimulation of afferent fibers in the mixed nerve with subsequent monosynaptic excitation of alpha motoneurons. Changes in the excitability of the reflex pathway are estimated by measuring the amplitude of the reflex.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Somatosensory Evoked Potential (SSEP)</measure>
    <time_frame>30 to 40 minutes before intervention, 30 to 40 minutes after intervention</time_frame>
    <description>A somatosensory evoked potential (SSEP) is the electrical activity response measured at the skin's surface along ascending sensory pathway following controlled peripheral nerve stimulation by tsDCS. For recording posterior tibial nerve SSEPs, the nerve is stimulated at the ankle, with the cathode midway between the Achilles tendon and the medial malleolus and the anode 3 cm distal to the cathode. Nerve stimulation should consist of a 0.1-0.2 ms duration square wave pulse at 3-5 Hertz (Hz). These pulses will be delivered by constant voltage stimulator applied transcutaneously over the targeted nerve. The stimulation intensity would exceed the motor threshold for eliciting a muscle twitch. Electromyogram (EMG)/ Nerve Conduction Velocity (NCV) measuring system will be used to measure SSEPs.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change Systolic Blood Pressure</measure>
    <time_frame>60 to 90 minutes before intervention, 60 to 90 minutes after intervention</time_frame>
    <description>Systolic Blood pressure will be recorded before and after each tsDCS session.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Diastolic Blood Pressure</measure>
    <time_frame>60 to 90 minutes before intervention,60 to 90 minutes after intervention ( for each intervention)</time_frame>
    <description>Diastolic Blood pressure will be recorded before and after delivering each intervention</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Heart Rate</measure>
    <time_frame>60 to 90 minutes before intervention,60 to 90 minutes after intervention ( for each intervention)</time_frame>
    <description>Heart rate will be recorded before and after delivering each intervention</description>
  </secondary_outcome>
  <number_of_arms>11</number_of_arms>
  <enrollment type="Actual">15</enrollment>
  <condition>Incomplete Spinal Cord Injury</condition>
  <arm_group>
    <arm_group_label>Anode, then Cathode, then Anode, then Sham, then Cathode tsDCS</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>5 tsDCS sessions were performed for each subject, with at least a 1 week washout period between tsDCS sessions. For each session, the subject was randomly assigned to cathodal, anodal or sham tsDCS. Each subject who completed the study received 2 cathodal, 2 anodal and 1 sham tsDCS session.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham, then Cathode, then Anode, then Anode, then Cathode tsDCS</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>5 tsDCS sessions were performed for each subject, with at least a 1 week washout period between tsDCS sessions. For each session, the subject was randomly assigned to cathodal, anodal or sham tsDCS. Each subject who completed the study received 2 cathodal, 2 anodal and 1 sham tsDCS session.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Anode, then Cathode, then Sham, then Anode, then Cathode tsDCS</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>5 tsDCS sessions were performed for each subject, with at least a 1 week washout period between tsDCS sessions. For each session, the subject was randomly assigned to cathodal, anodal or sham tsDCS. Each subject who completed the study received 2 cathodal, 2 anodal and 1 sham tsDCS session.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cathode, then Anode, then Cathode, then Anode, then Sham tsDCS</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>5 tsDCS sessions were performed for each subject, with at least a 1 week washout period between tsDCS sessions. For each session, the subject was randomly assigned to cathodal, anodal or sham tsDCS. Each subject who completed the study received 2 cathodal, 2 anodal and 1 sham tsDCS session.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Anode, then Anode, then Sham, then Cathode, then Cathode tsDCS</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>5 tsDCS sessions were performed for each subject, with at least a 1 week washout period between tsDCS sessions. For each session, the subject was randomly assigned to cathodal, anodal or sham tsDCS. Each subject who completed the study received 2 cathodal, 2 anodal and 1 sham tsDCS session.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham, then Anode, then Cathode, then Cathode, then Anode tsDCS</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>5 tsDCS sessions were performed for each subject, with at least a 1 week washout period between tsDCS sessions. For each session, the subject was randomly assigned to cathodal, anodal or sham tsDCS. Each subject who completed the study received 2 cathodal, 2 anodal and 1 sham tsDCS session.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cathode, then Anode, then Cathode, then Sham, then Anode tsDCS</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>5 tsDCS sessions were performed for each subject, with at least a 1 week washout period between tsDCS sessions. For each session, the subject was randomly assigned to cathodal, anodal or sham tsDCS. Each subject who completed the study received 2 cathodal, 2 anodal and 1 sham tsDCS session.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham, then Anode, then Cathode, then Anode, then Cathode tsDCS</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>5 tsDCS sessions were performed for each subject, with at least a 1 week washout period between tsDCS sessions. For each session, the subject was randomly assigned to cathodal, anodal or sham tsDCS. Each subject who completed the study received 2 cathodal, 2 anodal and 1 sham tsDCS session.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cathode, then Cathode, then Sham, then Anode, then Anode tsDCS</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>5 tsDCS sessions were performed for each subject, with at least a 1 week washout period between tsDCS sessions. For each session, the subject was randomly assigned to cathodal, anodal or sham tsDCS. Each subject who completed the study received 2 cathodal, 2 anodal and 1 sham tsDCS session.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Anode, Then Cathode, Then Anode, Then Cathode Then Sham tsDCS</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>5 tsDCS sessions were performed for each subject, with at least a 1 week washout period between tsDCS sessions. For each session, the subject was randomly assigned to cathodal, anodal or sham tsDCS. Each subject who completed the study received 2 cathodal, 2 anodal and 1 sham tsDCS session.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham, Then Anode, Then Anode, Then Cathode, Then Cathode tsDCS</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>5 tsDCS sessions were performed for each subject, with at least a 1 week washout period between tsDCS sessions. For each session, the subject was randomly assigned to cathodal, anodal or sham tsDCS. Each subject who completed the study received 2 cathodal, 2 anodal and 1 sham tsDCS session.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Anodal tsDCS</intervention_name>
    <description>During Anodal tsDCS intervention the positive end of the battery will be connected to the electrode on participant's back and negative end of the battery will be connected to the electrode on participant's shoulder. The battery will be turned on for 15 minutes, and the stimulation strength will be adjusted a couple of times per tolerance level.</description>
    <arm_group_label>Anode, Then Cathode, Then Anode, Then Cathode Then Sham tsDCS</arm_group_label>
    <arm_group_label>Anode, then Anode, then Sham, then Cathode, then Cathode tsDCS</arm_group_label>
    <arm_group_label>Anode, then Cathode, then Anode, then Sham, then Cathode tsDCS</arm_group_label>
    <arm_group_label>Anode, then Cathode, then Sham, then Anode, then Cathode tsDCS</arm_group_label>
    <arm_group_label>Cathode, then Anode, then Cathode, then Anode, then Sham tsDCS</arm_group_label>
    <arm_group_label>Cathode, then Anode, then Cathode, then Sham, then Anode tsDCS</arm_group_label>
    <arm_group_label>Cathode, then Cathode, then Sham, then Anode, then Anode tsDCS</arm_group_label>
    <arm_group_label>Sham, Then Anode, Then Anode, Then Cathode, Then Cathode tsDCS</arm_group_label>
    <arm_group_label>Sham, then Anode, then Cathode, then Anode, then Cathode tsDCS</arm_group_label>
    <arm_group_label>Sham, then Anode, then Cathode, then Cathode, then Anode tsDCS</arm_group_label>
    <arm_group_label>Sham, then Cathode, then Anode, then Anode, then Cathode tsDCS</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Cathodal tsDCS</intervention_name>
    <description>During Cathodal tsDCS intervention the negative end of the battery will be connected to the electrode on participant's back and positive end of the battery will be connected to the electrode on participant's shoulder. The battery will be turned on for 15 minutes, and the stimulation strength will be adjusted a couple of times per tolerance level.</description>
    <arm_group_label>Anode, Then Cathode, Then Anode, Then Cathode Then Sham tsDCS</arm_group_label>
    <arm_group_label>Anode, then Anode, then Sham, then Cathode, then Cathode tsDCS</arm_group_label>
    <arm_group_label>Anode, then Cathode, then Anode, then Sham, then Cathode tsDCS</arm_group_label>
    <arm_group_label>Anode, then Cathode, then Sham, then Anode, then Cathode tsDCS</arm_group_label>
    <arm_group_label>Cathode, then Anode, then Cathode, then Anode, then Sham tsDCS</arm_group_label>
    <arm_group_label>Cathode, then Anode, then Cathode, then Sham, then Anode tsDCS</arm_group_label>
    <arm_group_label>Cathode, then Cathode, then Sham, then Anode, then Anode tsDCS</arm_group_label>
    <arm_group_label>Sham, Then Anode, Then Anode, Then Cathode, Then Cathode tsDCS</arm_group_label>
    <arm_group_label>Sham, then Anode, then Cathode, then Anode, then Cathode tsDCS</arm_group_label>
    <arm_group_label>Sham, then Anode, then Cathode, then Cathode, then Anode tsDCS</arm_group_label>
    <arm_group_label>Sham, then Cathode, then Anode, then Anode, then Cathode tsDCS</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Sham tsDCS</intervention_name>
    <description>During Sham tsDCS intervention, battery will be turned off and no current will pass through the electrodes.</description>
    <arm_group_label>Anode, Then Cathode, Then Anode, Then Cathode Then Sham tsDCS</arm_group_label>
    <arm_group_label>Anode, then Anode, then Sham, then Cathode, then Cathode tsDCS</arm_group_label>
    <arm_group_label>Anode, then Cathode, then Anode, then Sham, then Cathode tsDCS</arm_group_label>
    <arm_group_label>Anode, then Cathode, then Sham, then Anode, then Cathode tsDCS</arm_group_label>
    <arm_group_label>Cathode, then Anode, then Cathode, then Anode, then Sham tsDCS</arm_group_label>
    <arm_group_label>Cathode, then Anode, then Cathode, then Sham, then Anode tsDCS</arm_group_label>
    <arm_group_label>Cathode, then Cathode, then Sham, then Anode, then Anode tsDCS</arm_group_label>
    <arm_group_label>Sham, Then Anode, Then Anode, Then Cathode, Then Cathode tsDCS</arm_group_label>
    <arm_group_label>Sham, then Anode, then Cathode, then Anode, then Cathode tsDCS</arm_group_label>
    <arm_group_label>Sham, then Anode, then Cathode, then Cathode, then Anode tsDCS</arm_group_label>
    <arm_group_label>Sham, then Cathode, then Anode, then Anode, then Cathode tsDCS</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Providing written informed consent prior to any study related procedures&#xD;
&#xD;
          -  18-65 years of age&#xD;
&#xD;
          -  Motor incomplete SCI classified as B, C or D by the American Spinal Injury Association&#xD;
             Impairment Scale (AIS)&#xD;
&#xD;
          -  Traumatic lesion at or above T8-T9 neurological level&#xD;
&#xD;
          -  Body mass index ≤ 30 (in order to facilitate reliable location of body landmarks&#xD;
             guiding stimulation);&#xD;
&#xD;
          -  Chronic SCI (time since injury&gt;6 months)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unstable cardiopulmonary conditions&#xD;
&#xD;
          -  History of seizure, head injury with loss of consciousness, severe alcohol or drug&#xD;
             abuse, and/or psychiatric illness&#xD;
&#xD;
          -  Any joint contracture or severe spasticity, as measured by a Modified Ashworth Score 4&#xD;
&#xD;
          -  Subject who cannot provide self-transportation to the study location&#xD;
&#xD;
          -  Cardiac or neural pacemakers&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  lower motor neuron injury (eg: peripheral neuropathy, cauda equina syndrome)&#xD;
&#xD;
          -  Uncontrolled diabetes with HbA1C&gt;7&#xD;
&#xD;
          -  History of severe autonomic dysreflexia&#xD;
&#xD;
          -  No planned alteration in therapy or medication for muscle tone during the course of&#xD;
             the study(No botulinum toxin injections in last 3 months, No phenol injections in last&#xD;
             6 months, intrathecal baclofen pump dose stable for past 3 months, etc)&#xD;
&#xD;
          -  Conditions for e.g., severe arthritis, extreme shoulder pain that would interfere with&#xD;
             valid administration of the measures or with interpreting motor testing;&#xD;
&#xD;
          -  No contraindications to tsDCS&#xD;
&#xD;
          -  ferromagnetic material in the brain or in the spine (except for titanium used in&#xD;
             segmental)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Radha Korupolu, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The University of Texas Health Science Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The University of Texas Health Science Center at Houston</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>August 2, 2017</study_first_submitted>
  <study_first_submitted_qc>August 9, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 15, 2017</study_first_posted>
  <results_first_submitted>October 23, 2019</results_first_submitted>
  <results_first_submitted_qc>January 27, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">February 13, 2020</results_first_posted>
  <last_update_submitted>January 27, 2020</last_update_submitted>
  <last_update_submitted_qc>January 27, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 13, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The University of Texas Health Science Center, Houston</investigator_affiliation>
    <investigator_full_name>Radha Korupolu</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>Incomplete SCI</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Spinal Cord Injuries</mesh_term>
    <mesh_term>Wounds and Injuries</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>August 18, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/54/NCT03249454/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>We recruited 15 subjects.</recruitment_details>
      <pre_assignment_details>2 enrolled participants were not assigned to an arm--one of these participant had leg edema that interfered with outcome assessment, and the second participant did not exhibit an H reflex due to a baclofen medication pump; therefore, these 2 participants were not randomized and did not start any intervention.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Anode, Then Cathode, Then Anode, Then Sham, Then Cathode tsDCS</title>
          <description>5 transcutaneous spinal direct current stimulation (tsDCS) sessions were performed for each subject, with at least a 1 week washout period between tsDCS sessions. For each session, the subject was randomly assigned to cathodal, anodal or sham tsDCS. Each subject who completed the study received 2 cathodal, 2 anodal and 1 sham tsDCS session.</description>
        </group>
        <group group_id="P2">
          <title>Sham, Then Cathode, Then Anode, Then Anode, Then Cathode tsDCS</title>
          <description>5 tsDCS sessions were performed for each subject, with at least a 1 week washout period between tsDCS sessions. For each session, the subject was randomly assigned to cathodal, anodal or sham tsDCS. Each subject who completed the study received 2 cathodal, 2 anodal and 1 sham tsDCS session.</description>
        </group>
        <group group_id="P3">
          <title>Anode, Then Cathode, Then Sham, Then Anode, Then Cathode tsDCS</title>
          <description>5 tsDCS sessions were performed for each subject, with at least a 1 week washout period between tsDCS sessions. For each session, the subject was randomly assigned to cathodal, anodal or sham tsDCS. Each subject who completed the study received 2 cathodal, 2 anodal and 1 sham tsDCS session.</description>
        </group>
        <group group_id="P4">
          <title>Cathode, Then Anode, Then Cathode, Then Anode, Then Sham tsDCS</title>
          <description>5 tsDCS sessions were performed for each subject, with at least a 1 week washout period between tsDCS sessions. For each session, the subject was randomly assigned to cathodal, anodal or sham tsDCS. Each subject who completed the study received 2 cathodal, 2 anodal and 1 sham tsDCS session.</description>
        </group>
        <group group_id="P5">
          <title>Anode, Then Anode, Then Sham, Then Cathode, Then Cathode tsDCS</title>
          <description>5 tsDCS sessions were performed for each subject, with at least a 1 week washout period between tsDCS sessions. For each session, the subject was randomly assigned to cathodal, anodal or sham tsDCS. Each subject who completed the study received 2 cathodal, 2 anodal and 1 sham tsDCS session.</description>
        </group>
        <group group_id="P6">
          <title>Sham, Then Anode, Then Cathode, Then Cathode, Then Anode tsDCS</title>
          <description>5 tsDCS sessions were performed for each subject, with at least a 1 week washout period between tsDCS sessions. For each session, the subject was randomly assigned to cathodal, anodal or sham tsDCS. Each subject who completed the study received 2 cathodal, 2 anodal and 1 sham tsDCS session.</description>
        </group>
        <group group_id="P7">
          <title>Cathode, Then Anode, Then Cathode, Then Sham, Then Anode tsDCS</title>
          <description>5 tsDCS sessions were performed for each subject, with at least a 1 week washout period between tsDCS sessions. For each session, the subject was randomly assigned to cathodal, anodal or sham tsDCS. Each subject who completed the study received 2 cathodal, 2 anodal and 1 sham tsDCS session.</description>
        </group>
        <group group_id="P8">
          <title>Sham, Then Anode, Then Cathode, Then Anode, Then Cathode tsDCS</title>
          <description>5 tsDCS sessions were performed for each subject, with at least a 1 week washout period between tsDCS sessions. For each session, the subject was randomly assigned to cathodal, anodal or sham tsDCS. Each subject who completed the study received 2 cathodal, 2 anodal and 1 sham tsDCS session.</description>
        </group>
        <group group_id="P9">
          <title>Cathode, Then Cathode, Then Sham, Then Anode, Then Anode tsDCS</title>
          <description>5 tsDCS sessions were performed for each subject, with at least a 1 week washout period between tsDCS sessions. For each session, the subject was randomly assigned to cathodal, anodal or sham tsDCS. Each subject who completed the study received 2 cathodal, 2 anodal and 1 sham tsDCS session.</description>
        </group>
        <group group_id="P10">
          <title>Anode, Then Cathode, Then Anode, Then Cathode Then Sham tsDCS</title>
          <description>5 tsDCS sessions were performed for each subject, with at least a 1 week washout period between tsDCS sessions. For each session, the subject was randomly assigned to cathodal, anodal or sham tsDCS. Each subject who completed the study received 2 cathodal, 2 anodal and 1 sham tsDCS session.</description>
        </group>
        <group group_id="P11">
          <title>Sham, Then Anode, Then Anode, Then Cathode, Then Cathode tsDCS</title>
          <description>5 tsDCS sessions were performed for each subject, with at least a 1 week washout period between tsDCS sessions. For each session, the subject was randomly assigned to cathodal, anodal or sham tsDCS. Each subject who completed the study received 2 cathodal, 2 anodal and 1 sham tsDCS session.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="1"/>
                <participants group_id="P6" count="2"/>
                <participants group_id="P7" count="1"/>
                <participants group_id="P8" count="1"/>
                <participants group_id="P9" count="1"/>
                <participants group_id="P10" count="1"/>
                <participants group_id="P11" count="1"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>First Intervention (1 Day)</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="1"/>
                <participants group_id="P6" count="2"/>
                <participants group_id="P7" count="1"/>
                <participants group_id="P8" count="1"/>
                <participants group_id="P9" count="1"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Washout (1 Week)</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="1"/>
                <participants group_id="P6" count="2"/>
                <participants group_id="P7" count="1"/>
                <participants group_id="P8" count="1"/>
                <participants group_id="P9" count="1"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Second Intervention (1 Day)</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="1"/>
                <participants group_id="P6" count="2"/>
                <participants group_id="P7" count="1"/>
                <participants group_id="P8" count="1"/>
                <participants group_id="P9" count="1"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Washout (1 Week)</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="1"/>
                <participants group_id="P6" count="2"/>
                <participants group_id="P7" count="1"/>
                <participants group_id="P8" count="1"/>
                <participants group_id="P9" count="1"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Third Intervention (1 Day)</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="1"/>
                <participants group_id="P6" count="2"/>
                <participants group_id="P7" count="1"/>
                <participants group_id="P8" count="1"/>
                <participants group_id="P9" count="1"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Washout (1 Week)</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="1"/>
                <participants group_id="P6" count="2"/>
                <participants group_id="P7" count="1"/>
                <participants group_id="P8" count="1"/>
                <participants group_id="P9" count="1"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Fourth Intervention (1 Day)</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="1"/>
                <participants group_id="P6" count="2"/>
                <participants group_id="P7" count="1"/>
                <participants group_id="P8" count="1"/>
                <participants group_id="P9" count="1"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Washout (1 Week)</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="1"/>
                <participants group_id="P6" count="2"/>
                <participants group_id="P7" count="1"/>
                <participants group_id="P8" count="1"/>
                <participants group_id="P9" count="1"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Fifth Intervention (1 Day)</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="1"/>
                <participants group_id="P6" count="2"/>
                <participants group_id="P7" count="1"/>
                <participants group_id="P8" count="1"/>
                <participants group_id="P9" count="1"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="1"/>
                <participants group_id="P6" count="2"/>
                <participants group_id="P7" count="1"/>
                <participants group_id="P8" count="1"/>
                <participants group_id="P9" count="1"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="1"/>
                <participants group_id="P11" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="1"/>
                <participants group_id="P11" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>All Participants</title>
          <description>5 tsDCS sessions were performed for each subject, with at least a 1 week washout period between tsDCS sessions. For each session, the subject was randomly assigned to cathodal, anodal or sham tsDCS. Each subject who completed the study received 2 cathodal, 2 anodal and 1 sham tsDCS session.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="15"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="37.40" spread="13.27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>African American</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Asian</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Caucasian</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hispanic/Latino</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Height</title>
          <units>centimeters</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="173.05" spread="7.90"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Weight</title>
          <units>kilograms</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="76.69" spread="16.92"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Employment Status</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Employed</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unemployed</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Student</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Marital Status</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Single</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Engaged</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Married</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Divorced</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percent Change in Hmax</title>
        <description>Immediately before application of tsDCS and after application of tsDCS, Hmax will be obtained from soleus muscle by stimulation of tibial nerve. The H-reflex is a compound muscle action potential elicited by low-threshold electrical stimulation of afferent fibers in the mixed nerve with subsequent monosynaptic excitation of alpha motoneurons. Changes in the excitability of the reflex pathway are estimated by measuring the amplitude of the reflex.</description>
        <time_frame>10 minutes before intervention, 10 minutes after intervention</time_frame>
        <population>Those who completed the study were analyzed. Data are reported per session. There were potentially 22 cathode, 22 anode, and 11 sham sessions. Data for the Right Lower Extremity were not collected for 3 cathode, 3 anode, and 2 sham sessions, and data for the Left Lower Extremity were not collected for 3 cathode, 1 anode, and 2 sham sessions.</population>
        <group_list>
          <group group_id="O1">
            <title>Cathodal tsDCS</title>
            <description>Each subject will be assigned to receive two cathodal tsDCS interventions randomly. There will be at least 1 week washout period between any 2 sessions.&#xD;
Cathodal tsDCS: During Cathodal tsDCS intervention the negative end of the battery will be connected to the electrode on participant's back and positive end of the battery will be connected to the electrode on participant's shoulder. The battery will be turned on for 15 minutes, and the stimulation strength will be adjusted a couple of times per tolerance level.</description>
          </group>
          <group group_id="O2">
            <title>Anodal tsDCS</title>
            <description>Each subject will be assigned to receive two anodal tsDCS interventions randomly. There will be at least 1 week washout period between any 2 sessions.&#xD;
Anodal tsDCS: During Anodal tsDCS intervention the positive end of the battery will be connected to the electrode on participant's back and negative end of the battery will be connected to the electrode on participant's shoulder. The battery will be turned on for 15 minutes, and the stimulation strength will be adjusted a couple of times per tolerance level.</description>
          </group>
          <group group_id="O3">
            <title>Sham tsDCS</title>
            <description>Each subject will be assigned to receive one sham tsDCS interventions randomly. There will be at least 1 week washout period between any 2 sessions.&#xD;
Sham tsDCS: During Sham tsDCS intervention, battery will be turned off and no current will pass through the electrodes.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change in Hmax</title>
          <description>Immediately before application of tsDCS and after application of tsDCS, Hmax will be obtained from soleus muscle by stimulation of tibial nerve. The H-reflex is a compound muscle action potential elicited by low-threshold electrical stimulation of afferent fibers in the mixed nerve with subsequent monosynaptic excitation of alpha motoneurons. Changes in the excitability of the reflex pathway are estimated by measuring the amplitude of the reflex.</description>
          <population>Those who completed the study were analyzed. Data are reported per session. There were potentially 22 cathode, 22 anode, and 11 sham sessions. Data for the Right Lower Extremity were not collected for 3 cathode, 3 anode, and 2 sham sessions, and data for the Left Lower Extremity were not collected for 3 cathode, 1 anode, and 2 sham sessions.</population>
          <units>percent change in Hmax</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <units_analyzed>sessions</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
                <count group_id="O2" value="11"/>
                <count group_id="O3" value="11"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>sessions</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="21"/>
                <count group_id="O3" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Right Lower Extremity</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="10"/>
                    <count group_id="O3" value="9"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>sessions</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="19"/>
                    <count group_id="O3" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27.85" spread="63.57"/>
                    <measurement group_id="O2" value="8.43" spread="29.21"/>
                    <measurement group_id="O3" value="-4.91" spread="39.12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Left Lower Extremity</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                    <count group_id="O2" value="11"/>
                    <count group_id="O3" value="11"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>sessions</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="21"/>
                    <count group_id="O3" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.20" spread="55.37"/>
                    <measurement group_id="O2" value="-3.99" spread="23.04"/>
                    <measurement group_id="O3" value="34.04" spread="94.72"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change in Somatosensory Evoked Potential (SSEP)</title>
        <description>A somatosensory evoked potential (SSEP) is the electrical activity response measured at the skin's surface along ascending sensory pathway following controlled peripheral nerve stimulation by tsDCS. For recording posterior tibial nerve SSEPs, the nerve is stimulated at the ankle, with the cathode midway between the Achilles tendon and the medial malleolus and the anode 3 cm distal to the cathode. Nerve stimulation should consist of a 0.1-0.2 ms duration square wave pulse at 3-5 Hertz (Hz). These pulses will be delivered by constant voltage stimulator applied transcutaneously over the targeted nerve. The stimulation intensity would exceed the motor threshold for eliciting a muscle twitch. Electromyogram (EMG)/ Nerve Conduction Velocity (NCV) measuring system will be used to measure SSEPs.</description>
        <time_frame>30 to 40 minutes before intervention, 30 to 40 minutes after intervention</time_frame>
        <population>Data was not collected for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Cathodal tsDCS</title>
            <description>Cathodal tsDCS: During Cathodal tsDCS intervention the negative end of the battery will be connected to the electrode on participant's back and positive end of the battery will be connected to the electrode on participant's shoulder. The battery will be turned on for 15 minutes, and the stimulation strength will be adjusted a couple of times per tolerance level.</description>
          </group>
          <group group_id="O2">
            <title>Anodal tsDCS</title>
            <description>Anodal tsDCS: During Anodal tsDCS intervention the positive end of the battery will be connected to the electrode on participant's back and negative end of the battery will be connected to the electrode on participant's shoulder. The battery will be turned on for 15 minutes, and the stimulation strength will be adjusted a couple of times per tolerance level.</description>
          </group>
          <group group_id="O3">
            <title>Sham tsDCS</title>
            <description>Sham tsDCS: During Sham tsDCS intervention, battery will be turned off and no current will pass through the electrodes.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Somatosensory Evoked Potential (SSEP)</title>
          <description>A somatosensory evoked potential (SSEP) is the electrical activity response measured at the skin's surface along ascending sensory pathway following controlled peripheral nerve stimulation by tsDCS. For recording posterior tibial nerve SSEPs, the nerve is stimulated at the ankle, with the cathode midway between the Achilles tendon and the medial malleolus and the anode 3 cm distal to the cathode. Nerve stimulation should consist of a 0.1-0.2 ms duration square wave pulse at 3-5 Hertz (Hz). These pulses will be delivered by constant voltage stimulator applied transcutaneously over the targeted nerve. The stimulation intensity would exceed the motor threshold for eliciting a muscle twitch. Electromyogram (EMG)/ Nerve Conduction Velocity (NCV) measuring system will be used to measure SSEPs.</description>
          <population>Data was not collected for this outcome measure.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
                <count group_id="O3" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change Systolic Blood Pressure</title>
        <description>Systolic Blood pressure will be recorded before and after each tsDCS session.</description>
        <time_frame>60 to 90 minutes before intervention, 60 to 90 minutes after intervention</time_frame>
        <population>Those who completed the study were analyzed. Data are reported per session. After randomization, there were potentially 22 cathode sessions, 22 anode sessions, and 11 sham sessions--of these sessions, data were not collected for 2 cathode sessions, 3 anode sessions, and 2 sham sessions.</population>
        <group_list>
          <group group_id="O1">
            <title>Cathodal tsDCS</title>
            <description>Cathodal tsDCS: During Cathodal tsDCS intervention the negative end of the battery will be connected to the electrode on participant's back and positive end of the battery will be connected to the electrode on participant's shoulder. The battery will be turned on for 15 minutes, and the stimulation strength will be adjusted a couple of times per tolerance level.</description>
          </group>
          <group group_id="O2">
            <title>Anodal tsDCS</title>
            <description>Anodal tsDCS: During Anodal tsDCS intervention the positive end of the battery will be connected to the electrode on participant's back and negative end of the battery will be connected to the electrode on participant's shoulder. The battery will be turned on for 15 minutes, and the stimulation strength will be adjusted a couple of times per tolerance level.</description>
          </group>
          <group group_id="O3">
            <title>Sham tsDCS</title>
            <description>Sham tsDCS: During Sham tsDCS intervention, battery will be turned off and no current will pass through the electrodes.</description>
          </group>
        </group_list>
        <measure>
          <title>Change Systolic Blood Pressure</title>
          <description>Systolic Blood pressure will be recorded before and after each tsDCS session.</description>
          <population>Those who completed the study were analyzed. Data are reported per session. After randomization, there were potentially 22 cathode sessions, 22 anode sessions, and 11 sham sessions--of these sessions, data were not collected for 2 cathode sessions, 3 anode sessions, and 2 sham sessions.</population>
          <units>millimeters of mercury (mmHg)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <units_analyzed>sessions</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
                <count group_id="O2" value="10"/>
                <count group_id="O3" value="9"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>sessions</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="19"/>
                <count group_id="O3" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.90" spread="13.31"/>
                    <measurement group_id="O2" value="7.58" spread="10.37"/>
                    <measurement group_id="O3" value="-4.00" spread="6.68"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Diastolic Blood Pressure</title>
        <description>Diastolic Blood pressure will be recorded before and after delivering each intervention</description>
        <time_frame>60 to 90 minutes before intervention,60 to 90 minutes after intervention ( for each intervention)</time_frame>
        <population>Those who completed the study were analyzed. Data are reported per session. After randomization, there were potentially 22 cathode sessions, 22 anode sessions, and 11 sham sessions--of these sessions, data were not collected for 2 cathode sessions, 3 anode sessions, and 2 sham sessions.</population>
        <group_list>
          <group group_id="O1">
            <title>Cathodal tsDCS</title>
            <description>Cathodal tsDCS: During Cathodal tsDCS intervention the negative end of the battery will be connected to the electrode on participant's back and positive end of the battery will be connected to the electrode on participant's shoulder. The battery will be turned on for 15 minutes, and the stimulation strength will be adjusted a couple of times per tolerance level.</description>
          </group>
          <group group_id="O2">
            <title>Anodal tsDCS</title>
            <description>Anodal tsDCS: During Anodal tsDCS intervention the positive end of the battery will be connected to the electrode on participant's back and negative end of the battery will be connected to the electrode on participant's shoulder. The battery will be turned on for 15 minutes, and the stimulation strength will be adjusted a couple of times per tolerance level.</description>
          </group>
          <group group_id="O3">
            <title>Sham tsDCS</title>
            <description>Sham tsDCS: During Sham tsDCS intervention, battery will be turned off and no current will pass through the electrodes.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Diastolic Blood Pressure</title>
          <description>Diastolic Blood pressure will be recorded before and after delivering each intervention</description>
          <population>Those who completed the study were analyzed. Data are reported per session. After randomization, there were potentially 22 cathode sessions, 22 anode sessions, and 11 sham sessions--of these sessions, data were not collected for 2 cathode sessions, 3 anode sessions, and 2 sham sessions.</population>
          <units>millimeters of mercury (mmHg)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <units_analyzed>sessions</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
                <count group_id="O2" value="10"/>
                <count group_id="O3" value="9"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>sessions</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="19"/>
                <count group_id="O3" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.80" spread="15.07"/>
                    <measurement group_id="O2" value="2.16" spread="6.65"/>
                    <measurement group_id="O3" value="-0.44" spread="9.06"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Heart Rate</title>
        <description>Heart rate will be recorded before and after delivering each intervention</description>
        <time_frame>60 to 90 minutes before intervention,60 to 90 minutes after intervention ( for each intervention)</time_frame>
        <population>Those who completed the study were analyzed. Data are reported per session. After randomization, there were potentially 22 cathode sessions, 22 anode sessions, and 11 sham sessions--of these sessions, data were not collected for 2 cathode sessions, 3 anode sessions, and 2 sham sessions.</population>
        <group_list>
          <group group_id="O1">
            <title>Cathodal tsDCS</title>
            <description>Cathodal tsDCS: During Cathodal tsDCS intervention the negative end of the battery will be connected to the electrode on participant's back and positive end of the battery will be connected to the electrode on participant's shoulder. The battery will be turned on for 15 minutes, and the stimulation strength will be adjusted a couple of times per tolerance level.</description>
          </group>
          <group group_id="O2">
            <title>Anodal tsDCS</title>
            <description>Anodal tsDCS: During Anodal tsDCS intervention the positive end of the battery will be connected to the electrode on participant's back and negative end of the battery will be connected to the electrode on participant's shoulder. The battery will be turned on for 15 minutes, and the stimulation strength will be adjusted a couple of times per tolerance level.</description>
          </group>
          <group group_id="O3">
            <title>Sham tsDCS</title>
            <description>Sham tsDCS: During Sham tsDCS intervention, battery will be turned off and no current will pass through the electrodes.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Heart Rate</title>
          <description>Heart rate will be recorded before and after delivering each intervention</description>
          <population>Those who completed the study were analyzed. Data are reported per session. After randomization, there were potentially 22 cathode sessions, 22 anode sessions, and 11 sham sessions--of these sessions, data were not collected for 2 cathode sessions, 3 anode sessions, and 2 sham sessions.</population>
          <units>beats per minute (bpm)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <units_analyzed>sessions</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
                <count group_id="O2" value="10"/>
                <count group_id="O3" value="9"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>sessions</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="19"/>
                <count group_id="O3" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-7.35" spread="5.28"/>
                    <measurement group_id="O2" value="-6.53" spread="6.99"/>
                    <measurement group_id="O3" value="-4.78" spread="5.63"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>5 weeks</time_frame>
      <desc>The urinary tract infection (UTI) was unrelated to the intervention--this subject developed a UTI after randomization and completion of one anodal stimulation session.&#xD;
Bruising was related to outcome measure collection (that is, related to preparation for measurement of h-reflex, which involves cleaning of the skin and placing electrodes) but unrelated to the intervention--this subject withdrew after randomization and completion of one session of sham stimulation.</desc>
      <group_list>
        <group group_id="E1">
          <title>Cathodal tsDCS</title>
          <description>Each subject will be assigned to receive two cathodal tsDCS interventions randomly. There will be at least 1 week washout period between any 2 sessions.&#xD;
Cathodal tsDCS: During Cathodal tsDCS intervention the negative end of the battery will be connected to the electrode on participant's back and positive end of the battery will be connected to the electrode on participant's shoulder. The battery will be turned on for 15 minutes, and the stimulation strength will be adjusted a couple of times per tolerance level.</description>
        </group>
        <group group_id="E2">
          <title>Anodal tsDCS</title>
          <description>Each subject will be assigned to receive two anodal tsDCS interventions randomly. There will be at least 1 week washout period between any 2 sessions.&#xD;
Anodal tsDCS: During Anodal tsDCS intervention the positive end of the battery will be connected to the electrode on participant's back and negative end of the battery will be connected to the electrode on participant's shoulder. The battery will be turned on for 15 minutes, and the stimulation strength will be adjusted a couple of times per tolerance level.</description>
        </group>
        <group group_id="E3">
          <title>Sham tsDCS</title>
          <description>Each subject will be assigned to receive one sham tsDCS interventions randomly. There will be at least 1 week washout period between any 2 sessions.&#xD;
Sham tsDCS: During Sham tsDCS intervention, battery will be turned off and no current will pass through the electrodes.</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Hospitalization for Urinary Tract Infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Bruising</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>Small sample size. We did not control for timing of oral anti-spasticity medications during different trials which can effect H reflex measurement.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Radha Korupolu, MD, MS</name_or_title>
      <organization>The University of Texas Health Science Center at Houston</organization>
      <phone>713-797-6976</phone>
      <email>Radha.Korupolu@uth.tmc.edu</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03249454
org study id: HSC-MS-17-0166
nct id: NCT03249454
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
is us export: No
The purpose of the study is to investigate the effects of a novel therapeutic approach with
      transcutaneous spinal direct current stimulation (tsDCS) to promote functional recovery and
      spasticity in chronic spinal cord injury (SCI).
The purpose of the study is to investigate the effects of a novel therapeutic approach to
      promote functional recovery and spasticity in chronic SCI. The tsDCS effect on
      neuro-physiological measures such as H reflex and somatosensory evoked potential (SSEP) wiil
      be evaluated in subjects with SCI. This incremental, design will allow the establishment of
      strong electrophysiological data prior to rapid clinical translation of the findings about
      this promising, early-stage technique.

      The central hypothesis is twofold: 1) active tsDCS will lead to a change in Hmax/M max ratio
      than sham tsDCS, in a polarity dependent manner; and 2) active tsDCS will lead to a change in
      SSEP amplitude and latency, in a polarity dependent manner.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: Crossover design with 9 arms: Anodal tsDCS, Cathodal tsDCS, Sham tsDCS
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Percent Change in Hmax
time frame: 10 minutes before intervention, 10 minutes after intervention
description: Immediately before application of tsDCS and after application of tsDCS, Hmax will be obtained from soleus muscle by stimulation of tibial nerve. The H-reflex is a compound muscle action potential elicited by low-threshold electrical stimulation of afferent fibers in the mixed nerve with subsequent monosynaptic excitation of alpha motoneurons. Changes in the excitability of the reflex pathway are estimated by measuring the amplitude of the reflex.
measure: Change in Somatosensory Evoked Potential (SSEP)
time frame: 30 to 40 minutes before intervention, 30 to 40 minutes after intervention
description: A somatosensory evoked potential (SSEP) is the electrical activity response measured at the skin's surface along ascending sensory pathway following controlled peripheral nerve stimulation by tsDCS. For recording posterior tibial nerve SSEPs, the nerve is stimulated at the ankle, with the cathode midway between the Achilles tendon and the medial malleolus and the anode 3 cm distal to the cathode. Nerve stimulation should consist of a 0.1-0.2 ms duration square wave pulse at 3-5 Hertz (Hz). These pulses will be delivered by constant voltage stimulator applied transcutaneously over the targeted nerve. The stimulation intensity would exceed the motor threshold for eliciting a muscle twitch. Electromyogram (EMG)/ Nerve Conduction Velocity (NCV) measuring system will be used to measure SSEPs.
measure: Change Systolic Blood Pressure
time frame: 60 to 90 minutes before intervention, 60 to 90 minutes after intervention
description: Systolic Blood pressure will be recorded before and after each tsDCS session.
measure: Change in Diastolic Blood Pressure
time frame: 60 to 90 minutes before intervention,60 to 90 minutes after intervention ( for each intervention)
description: Diastolic Blood pressure will be recorded before and after delivering each intervention
measure: Change in Heart Rate
time frame: 60 to 90 minutes before intervention,60 to 90 minutes after intervention ( for each intervention)
description: Heart rate will be recorded before and after delivering each intervention
arm group label: Anode, then Cathode, then Anode, then Sham, then Cathode tsDCS
arm group type: Experimental
description: 5 tsDCS sessions were performed for each subject, with at least a 1 week washout period between tsDCS sessions. For each session, the subject was randomly assigned to cathodal, anodal or sham tsDCS. Each subject who completed the study received 2 cathodal, 2 anodal and 1 sham tsDCS session.
arm group label: Sham, then Cathode, then Anode, then Anode, then Cathode tsDCS
arm group type: Experimental
description: 5 tsDCS sessions were performed for each subject, with at least a 1 week washout period between tsDCS sessions. For each session, the subject was randomly assigned to cathodal, anodal or sham tsDCS. Each subject who completed the study received 2 cathodal, 2 anodal and 1 sham tsDCS session.
arm group label: Anode, then Cathode, then Sham, then Anode, then Cathode tsDCS
arm group type: Experimental
description: 5 tsDCS sessions were performed for each subject, with at least a 1 week washout period between tsDCS sessions. For each session, the subject was randomly assigned to cathodal, anodal or sham tsDCS. Each subject who completed the study received 2 cathodal, 2 anodal and 1 sham tsDCS session.
arm group label: Cathode, then Anode, then Cathode, then Anode, then Sham tsDCS
arm group type: Experimental
description: 5 tsDCS sessions were performed for each subject, with at least a 1 week washout period between tsDCS sessions. For each session, the subject was randomly assigned to cathodal, anodal or sham tsDCS. Each subject who completed the study received 2 cathodal, 2 anodal and 1 sham tsDCS session.
arm group label: Anode, then Anode, then Sham, then Cathode, then Cathode tsDCS
arm group type: Experimental
description: 5 tsDCS sessions were performed for each subject, with at least a 1 week washout period between tsDCS sessions. For each session, the subject was randomly assigned to cathodal, anodal or sham tsDCS. Each subject who completed the study received 2 cathodal, 2 anodal and 1 sham tsDCS session.
arm group label: Sham, then Anode, then Cathode, then Cathode, then Anode tsDCS
arm group type: Experimental
description: 5 tsDCS sessions were performed for each subject, with at least a 1 week washout period between tsDCS sessions. For each session, the subject was randomly assigned to cathodal, anodal or sham tsDCS. Each subject who completed the study received 2 cathodal, 2 anodal and 1 sham tsDCS session.
arm group label: Cathode, then Anode, then Cathode, then Sham, then Anode tsDCS
arm group type: Experimental
description: 5 tsDCS sessions were performed for each subject, with at least a 1 week washout period between tsDCS sessions. For each session, the subject was randomly assigned to cathodal, anodal or sham tsDCS. Each subject who completed the study received 2 cathodal, 2 anodal and 1 sham tsDCS session.
arm group label: Sham, then Anode, then Cathode, then Anode, then Cathode tsDCS
arm group type: Experimental
description: 5 tsDCS sessions were performed for each subject, with at least a 1 week washout period between tsDCS sessions. For each session, the subject was randomly assigned to cathodal, anodal or sham tsDCS. Each subject who completed the study received 2 cathodal, 2 anodal and 1 sham tsDCS session.
arm group label: Cathode, then Cathode, then Sham, then Anode, then Anode tsDCS
arm group type: Experimental
description: 5 tsDCS sessions were performed for each subject, with at least a 1 week washout period between tsDCS sessions. For each session, the subject was randomly assigned to cathodal, anodal or sham tsDCS. Each subject who completed the study received 2 cathodal, 2 anodal and 1 sham tsDCS session.
arm group label: Anode, Then Cathode, Then Anode, Then Cathode Then Sham tsDCS
arm group type: Experimental
description: 5 tsDCS sessions were performed for each subject, with at least a 1 week washout period between tsDCS sessions. For each session, the subject was randomly assigned to cathodal, anodal or sham tsDCS. Each subject who completed the study received 2 cathodal, 2 anodal and 1 sham tsDCS session.
arm group label: Sham, Then Anode, Then Anode, Then Cathode, Then Cathode tsDCS
arm group type: Experimental
description: 5 tsDCS sessions were performed for each subject, with at least a 1 week washout period between tsDCS sessions. For each session, the subject was randomly assigned to cathodal, anodal or sham tsDCS. Each subject who completed the study received 2 cathodal, 2 anodal and 1 sham tsDCS session.
intervention type: Device
intervention name: Anodal tsDCS
description: During Anodal tsDCS intervention the positive end of the battery will be connected to the electrode on participant's back and negative end of the battery will be connected to the electrode on participant's shoulder. The battery will be turned on for 15 minutes, and the stimulation strength will be adjusted a couple of times per tolerance level.
arm group label: Anode, Then Cathode, Then Anode, Then Cathode Then Sham tsDCS
arm group label: Anode, then Anode, then Sham, then Cathode, then Cathode tsDCS
arm group label: Anode, then Cathode, then Anode, then Sham, then Cathode tsDCS
arm group label: Anode, then Cathode, then Sham, then Anode, then Cathode tsDCS
arm group label: Cathode, then Anode, then Cathode, then Anode, then Sham tsDCS
arm group label: Cathode, then Anode, then Cathode, then Sham, then Anode tsDCS
arm group label: Cathode, then Cathode, then Sham, then Anode, then Anode tsDCS
arm group label: Sham, Then Anode, Then Anode, Then Cathode, Then Cathode tsDCS
arm group label: Sham, then Anode, then Cathode, then Anode, then Cathode tsDCS
arm group label: Sham, then Anode, then Cathode, then Cathode, then Anode tsDCS
arm group label: Sham, then Cathode, then Anode, then Anode, then Cathode tsDCS
intervention type: Device
intervention name: Cathodal tsDCS
description: During Cathodal tsDCS intervention the negative end of the battery will be connected to the electrode on participant's back and positive end of the battery will be connected to the electrode on participant's shoulder. The battery will be turned on for 15 minutes, and the stimulation strength will be adjusted a couple of times per tolerance level.
arm group label: Anode, Then Cathode, Then Anode, Then Cathode Then Sham tsDCS
arm group label: Anode, then Anode, then Sham, then Cathode, then Cathode tsDCS
arm group label: Anode, then Cathode, then Anode, then Sham, then Cathode tsDCS
arm group label: Anode, then Cathode, then Sham, then Anode, then Cathode tsDCS
arm group label: Cathode, then Anode, then Cathode, then Anode, then Sham tsDCS
arm group label: Cathode, then Anode, then Cathode, then Sham, then Anode tsDCS
arm group label: Cathode, then Cathode, then Sham, then Anode, then Anode tsDCS
arm group label: Sham, Then Anode, Then Anode, Then Cathode, Then Cathode tsDCS
arm group label: Sham, then Anode, then Cathode, then Anode, then Cathode tsDCS
arm group label: Sham, then Anode, then Cathode, then Cathode, then Anode tsDCS
arm group label: Sham, then Cathode, then Anode, then Anode, then Cathode tsDCS
intervention type: Device
intervention name: Sham tsDCS
description: During Sham tsDCS intervention, battery will be turned off and no current will pass through the electrodes.
arm group label: Anode, Then Cathode, Then Anode, Then Cathode Then Sham tsDCS
arm group label: Anode, then Anode, then Sham, then Cathode, then Cathode tsDCS
arm group label: Anode, then Cathode, then Anode, then Sham, then Cathode tsDCS
arm group label: Anode, then Cathode, then Sham, then Anode, then Cathode tsDCS
arm group label: Cathode, then Anode, then Cathode, then Anode, then Sham tsDCS
arm group label: Cathode, then Anode, then Cathode, then Sham, then Anode tsDCS
arm group label: Cathode, then Cathode, then Sham, then Anode, then Anode tsDCS
arm group label: Sham, Then Anode, Then Anode, Then Cathode, Then Cathode tsDCS
arm group label: Sham, then Anode, then Cathode, then Anode, then Cathode tsDCS
arm group label: Sham, then Anode, then Cathode, then Cathode, then Anode tsDCS
arm group label: Sham, then Cathode, then Anode, then Anode, then Cathode tsDCS
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Radha Korupolu, MD
role: Principal Investigator
affiliation: The University of Texas Health Science Center
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: The University of Texas Health Science Center, Houston
investigator full name: Radha Korupolu
investigator title: Assistant Professor
mesh term: Spinal Cord Injuries
mesh term: Wounds and Injuries
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Small sample size. We did not control for timing of oral anti-spasticity medications during different trials which can effect H reflex measurement.
point of contact: 