xml: <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/NCT06029075</url>
    </required_header>
    <id_info>
      <org_study_id>HSC-MS-22-0046 (Experiment 2)</org_study_id>
      <nct_id>NCT06029075</nct_id>
    </id_info>
    <brief_title>tACS for Neuropathic Pain Management After SCI</brief_title>
    <official_title>tACS Brain Neuromodulation for Sensory and Motor Recovery After Neurological Impairments</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>The University of Texas Health Science Center, Houston</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </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 overall goal is to investigate the effectiveness of a novel intervention - transcranial&#xD;
        alternating current stimulation (tACS) for neuropathic pain management in people after spinal&#xD;
        cord injury.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">August 1, 2027</completion_date>
    <primary_completion_date type="Anticipated">August 1, 2027</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>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Participant)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Pain scale (visual analogue scale, VAS) measurement</measure>
      <time_frame>Change of VAS 5 minutes before and after the tACS intervention will be measured.</time_frame>
      <description>The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between &quot;no pain&quot; and &quot;worst pain.&quot;</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Heart rate variability (HRV) measurement</measure>
      <time_frame>Change of HRV 10-15 minutes before and after the tACS intervention will be measured.</time_frame>
      <description>Heart rate variability (HRV) is the fluctuation in the time intervals between adjacent heartbeats (1). HRV indexes neurocardiac function and is generated by heart-brain interactions and dynamic non-linear autonomic nervous system (ANS) processes. HRV will be used as a surrogate assessment for autonomic nerve system</description>
    </primary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">14</enrollment>
    <condition>Neuropathic Pain Management</condition>
    <arm_group>
      <arm_group_label>&quot;tACS Sham, tACS 10Hz, tACS 20Hz&quot; experimental order</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>tACS Sham is a temporary non-invasive electrical stimulation that applies a weak oscillatory current to the brain through the scalp for up to 30 second, it is not designed to entrain neuronal activity into any external regulatory frequency patterns.&#xD;
  tACS 10Hz is a 10Hz non-invasive electrical stimulation that applies a weak oscillatory current to the brain through the scalp or 20 or 40 minutes to entrain neuronal activity into 10Hz frequency patterns.&#xD;
  tACS 20Hz is a 20Hz non-invasive electrical stimulation that applies a weak oscillatory current to the brain through the scalp for 20 or 40 minutes to entrain neuronal activity into 20Hz frequency patterns.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>&quot;HD-tACS 20Hz, HD-tACS 10Hz, HD-tACS Sham&quot; experimental order</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>tACS 20Hz is a 20Hz non-invasive electrical stimulation that applies a weak oscillatory current to the brain through the scalp for 20 or 40 minutes to entrain neuronal activity into 20Hz frequency patterns.&#xD;
  tACS 10Hz is a 10Hz non-invasive electrical stimulation that applies a weak oscillatory current to the brain through the scalp or 20 or 40 minutes to entrain neuronal activity into 10Hz frequency patterns.&#xD;
  tACS Sham is a temporary non-invasive electrical stimulation that applies a weak oscillatory current to the brain through the scalp for up to 30 second, it is not designed to entrain neuronal activity into any external regulatory frequency patterns.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>&quot;HD-tACS 10Hz, HD-tACS 20Hz, HD-tACS Sham&quot; experimental order</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>tACS 10Hz is a 10Hz non-invasive electrical stimulation that applies a weak oscillatory current to the brain through the scalp or 20 or 40 minutes to entrain neuronal activity into 10Hz frequency patterns.&#xD;
  tACS 20Hz is a 20Hz non-invasive electrical stimulation that applies a weak oscillatory current to the brain through the scalp for 20 or 40 minutes to entrain neuronal activity into 20Hz frequency patterns.&#xD;
  tACS Sham is a temporary non-invasive electrical stimulation that applies a weak oscillatory current to the brain through the scalp for up to 30 second, it is not designed to entrain neuronal activity into any external regulatory frequency patterns.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>tACS Sham</intervention_name>
      <description>Sham tACS will applied to the brain through the scalp for 20 minutes.</description>
      <arm_group_label>&quot;HD-tACS 10Hz, HD-tACS 20Hz, HD-tACS Sham&quot; experimental order</arm_group_label>
      <arm_group_label>&quot;HD-tACS 20Hz, HD-tACS 10Hz, HD-tACS Sham&quot; experimental order</arm_group_label>
      <arm_group_label>&quot;tACS Sham, tACS 10Hz, tACS 20Hz&quot; experimental order</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>tACS 10Hz</intervention_name>
      <description>10Hz tACS will applied to the brain through the scalp for 20 minutes.</description>
      <arm_group_label>&quot;HD-tACS 10Hz, HD-tACS 20Hz, HD-tACS Sham&quot; experimental order</arm_group_label>
      <arm_group_label>&quot;HD-tACS 20Hz, HD-tACS 10Hz, HD-tACS Sham&quot; experimental order</arm_group_label>
      <arm_group_label>&quot;tACS Sham, tACS 10Hz, tACS 20Hz&quot; experimental order</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>tACS 20Hz</intervention_name>
      <description>20Hz tACS will applied to the brain through the scalp for 20 minutes.</description>
      <arm_group_label>&quot;HD-tACS 10Hz, HD-tACS 20Hz, HD-tACS Sham&quot; experimental order</arm_group_label>
      <arm_group_label>&quot;HD-tACS 20Hz, HD-tACS 10Hz, HD-tACS Sham&quot; experimental order</arm_group_label>
      <arm_group_label>&quot;tACS Sham, tACS 10Hz, tACS 20Hz&quot; experimental order</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion/exclusion criteria for SCI subjects&#xD;
  &#xD;
          Inclusion criteria: A patient who&#xD;
  &#xD;
            1. has neuropathic pain after traumatic spinal cord injury or amputation or brain injury;&#xD;
  &#xD;
            2. has chronic pain, &gt;3 months;&#xD;
  &#xD;
            3. is between 18 to 75 years of age;&#xD;
  &#xD;
            4. is stable on oral pain medications at least two weeks. Patients are allowed to&#xD;
               continue their pain medications, i.e., no change in pain medications.&#xD;
  &#xD;
          NOTE: we plan to begin the study with the spinal cord injury (SCI) subject population as a&#xD;
          cohort first, then expand to other subject populations&#xD;
  &#xD;
          Exclusion criteria: Patients will be excluded if they&#xD;
  &#xD;
            1. are currently adjusting oral pain medications for their neuropathic pain;&#xD;
  &#xD;
            2. have pain, but not neuropathic, e.g., from inflammation at the incision wound of the&#xD;
               residual limb or neuroma;&#xD;
  &#xD;
            3. have a pacemaker metal implants or supplemental oxygen;&#xD;
  &#xD;
            4. have amputation in their arm(s);&#xD;
  &#xD;
            5. fail to have a motor contraction in the arm muscles with TMS;&#xD;
  &#xD;
            6. are not able to follow commands, or to give consent;&#xD;
  &#xD;
            7. have asthma or other pulmonary disease;&#xD;
  &#xD;
            8. are not medically stable;&#xD;
  &#xD;
            9. have preexisting psychiatric disorders;&#xD;
  &#xD;
           10. alcohol or drug abuse.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>75 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Sheng Li, MD, Ph.D</last_name>
      <role>Principal Investigator</role>
      <affiliation>The University of Texas Health Science Center, Houston</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Sheng Li, MD, Ph.D</last_name>
      <phone>(713) 797-7125</phone>
      <email>sheng.li@uth.tmc.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Shengai Li, MS</last_name>
      <phone>713-797-7561</phone>
      <email>shengai.li@uth.tmc.edu</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>The University of Texas Health Science Center</name>
        <address>
          <city>Houston</city>
          <state>Texas</state>
          <zip>77030</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Sheng Li, MD, PhD</last_name>
        <phone>713-797-7125</phone>
        <email>sheng.li@uth.tmc.edu</email>
      </contact>
      <contact_backup>
        <last_name>Shengai Li, MS</last_name>
        <phone>713-797-7561</phone>
        <email>shengai.li@uth.tmc.edu</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>May 10, 2023</study_first_submitted>
    <study_first_submitted_qc>August 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 8, 2023</study_first_posted>
    <last_update_submitted>August 31, 2023</last_update_submitted>
    <last_update_submitted_qc>August 31, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 8, 2023</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>Sheng Li</investigator_full_name>
      <investigator_title>Professor</investigator_title>
    </responsible_party>
    <keyword>tACS</keyword>
    <keyword>Neuropathic Pain</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Neuralgia</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06029075
  org study id: HSC-MS-22-0046 (Experiment 2)
  nct id: NCT06029075
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: Yes
  is unapproved device: Yes
  is us export: No
  The overall goal is to investigate the effectiveness of a novel intervention - transcranial
        alternating current stimulation (tACS) for neuropathic pain management in people after spinal
        cord injury.
  allocation: Randomized
  intervention model: Crossover Assignment
  primary purpose: Treatment
  masking: Single (Participant)
  measure: Pain scale (visual analogue scale, VAS) measurement
  time frame: Change of VAS 5 minutes before and after the tACS intervention will be measured.
  description: The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain."
  measure: Heart rate variability (HRV) measurement
  time frame: Change of HRV 10-15 minutes before and after the tACS intervention will be measured.
  description: Heart rate variability (HRV) is the fluctuation in the time intervals between adjacent heartbeats (1). HRV indexes neurocardiac function and is generated by heart-brain interactions and dynamic non-linear autonomic nervous system (ANS) processes. HRV will be used as a surrogate assessment for autonomic nerve system
  arm group label: "tACS Sham, tACS 10Hz, tACS 20Hz" experimental order
  arm group type: Experimental
  description: tACS Sham is a temporary non-invasive electrical stimulation that applies a weak oscillatory current to the brain through the scalp for up to 30 second, it is not designed to entrain neuronal activity into any external regulatory frequency patterns.
  tACS 10Hz is a 10Hz non-invasive electrical stimulation that applies a weak oscillatory current to the brain through the scalp or 20 or 40 minutes to entrain neuronal activity into 10Hz frequency patterns.
  tACS 20Hz is a 20Hz non-invasive electrical stimulation that applies a weak oscillatory current to the brain through the scalp for 20 or 40 minutes to entrain neuronal activity into 20Hz frequency patterns.
  arm group label: "HD-tACS 20Hz, HD-tACS 10Hz, HD-tACS Sham" experimental order
  arm group type: Experimental
  description: tACS 20Hz is a 20Hz non-invasive electrical stimulation that applies a weak oscillatory current to the brain through the scalp for 20 or 40 minutes to entrain neuronal activity into 20Hz frequency patterns.
  tACS 10Hz is a 10Hz non-invasive electrical stimulation that applies a weak oscillatory current to the brain through the scalp or 20 or 40 minutes to entrain neuronal activity into 10Hz frequency patterns.
  tACS Sham is a temporary non-invasive electrical stimulation that applies a weak oscillatory current to the brain through the scalp for up to 30 second, it is not designed to entrain neuronal activity into any external regulatory frequency patterns.
  arm group label: "HD-tACS 10Hz, HD-tACS 20Hz, HD-tACS Sham" experimental order
  arm group type: Experimental
  description: tACS 10Hz is a 10Hz non-invasive electrical stimulation that applies a weak oscillatory current to the brain through the scalp or 20 or 40 minutes to entrain neuronal activity into 10Hz frequency patterns.
  tACS 20Hz is a 20Hz non-invasive electrical stimulation that applies a weak oscillatory current to the brain through the scalp for 20 or 40 minutes to entrain neuronal activity into 20Hz frequency patterns.
  tACS Sham is a temporary non-invasive electrical stimulation that applies a weak oscillatory current to the brain through the scalp for up to 30 second, it is not designed to entrain neuronal activity into any external regulatory frequency patterns.
  intervention type: Device
  intervention name: tACS Sham
  description: Sham tACS will applied to the brain through the scalp for 20 minutes.
  arm group label: "HD-tACS 10Hz, HD-tACS 20Hz, HD-tACS Sham" experimental order
  arm group label: "HD-tACS 20Hz, HD-tACS 10Hz, HD-tACS Sham" experimental order
  arm group label: "tACS Sham, tACS 10Hz, tACS 20Hz" experimental order
  intervention type: Device
  intervention name: tACS 10Hz
  description: 10Hz tACS will applied to the brain through the scalp for 20 minutes.
  arm group label: "HD-tACS 10Hz, HD-tACS 20Hz, HD-tACS Sham" experimental order
  arm group label: "HD-tACS 20Hz, HD-tACS 10Hz, HD-tACS Sham" experimental order
  arm group label: "tACS Sham, tACS 10Hz, tACS 20Hz" experimental order
  intervention type: Device
  intervention name: tACS 20Hz
  description: 20Hz tACS will applied to the brain through the scalp for 20 minutes.
  arm group label: "HD-tACS 10Hz, HD-tACS 20Hz, HD-tACS Sham" experimental order
  arm group label: "HD-tACS 20Hz, HD-tACS 10Hz, HD-tACS Sham" experimental order
  arm group label: "tACS Sham, tACS 10Hz, tACS 20Hz" experimental order
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 75 Years
  healthy volunteers: No
  last name: Sheng Li, MD, Ph.D
  role: Principal Investigator
  affiliation: The University of Texas Health Science Center, Houston
  last name: Sheng Li, MD, Ph.D
  phone: (713) 797-7125
  email: sheng.li@uth.tmc.edu
  last name: Shengai Li, MS
  phone: 713-797-7561
  email: shengai.li@uth.tmc.edu
  facility: 
  contact: 
  contact backup: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: The University of Texas Health Science Center, Houston
  investigator full name: Sheng Li
  investigator title: Professor
  mesh term: Neuralgia
  sharing ipd: No