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/NCT05982171</url>
    </required_header>
    <id_info>
      <org_study_id>IRB#2023877</org_study_id>
      <nct_id>NCT05982171</nct_id>
    </id_info>
    <brief_title>Transcutaneous Spinal Cord Stimulation to Promote Walking Recovery After Spinal Cord Injury</brief_title>
    <official_title>Transcutaneous Spinal Cord Stimulation to Promote Walking Recovery After Spinal Cord Injury</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Craig Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Craig Hospital</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this clinical trial is to investigate the effects of transcutaneous spinal cord&#xD;
        stimulation (TSCS) combined with exoskeleton training, as compared to exoskeleton training&#xD;
        alone to improve motor function in individuals with incomplete spinal cord injury who are 12&#xD;
        months or less post-injury. Participants will be randomly assigned to a treatment group&#xD;
        (exoskeleton training with TSCS, or exoskeleton training without TSCS). Participants in both&#xD;
        groups will undergo a baseline evaluation, then take part in 24, 1-hour training sessions at&#xD;
        Craig Hospital. After the 24 sessions have concluded, participants will undergo a&#xD;
        post-treatment evaluation as well as a follow-up evaluation four weeks after training is&#xD;
        completed. Researchers will compare the two groups by evaluating the following areas:&#xD;
  &#xD;
          -  walking ability and speed&#xD;
  &#xD;
          -  lower extremity strength, activation, and spasticity&#xD;
  &#xD;
          -  trunk control&#xD;
  &#xD;
          -  bowel and bladder function&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 15, 2023</start_date>
    <completion_date type="Anticipated">September 15, 2024</completion_date>
    <primary_completion_date type="Anticipated">September 15, 2024</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>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Double (Participant, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Change in score on Walking Index for SCI (WISCI) II</measure>
      <time_frame>Baseline to Immediately After Intervention</time_frame>
      <description>Assesses the amount of physical assistance/devices needed for walking following paralysis from SCI (scale of 0-20 with higher score indicating less need for assistance)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change in walking speed as measured by the 10 Meter Walk Test</measure>
      <time_frame>Baseline to Immediately After Intervention</time_frame>
      <description>Participants walk a ten-meter track; time to walk the middle six meters is recorded and converted to meters/second (speed)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in distance walked as measured by the 6 Meter Walk Test</measure>
      <time_frame>Baseline to Immediately After Intervention</time_frame>
      <description>Measures distance walked (in meters) over 6 minute time period</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in lower extremity strength as measured by Lower Extremity Motor Score (LEMS)</measure>
      <time_frame>Baseline to Post-treatment</time_frame>
      <description>Assesses strength in 10 lower extremity muscle groups (each muscle scored 0-5 with higher score for greater strength; total score ranges 0-50.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in spasm frequency and severity as measured by Penn Spasm Frequency</measure>
      <time_frame>Baseline to Immediately After Intervention</time_frame>
      <description>Self-report measure of perception of spasticity frequency (0 to 5 scale with higher score more frequent spasms) and severity (1-3 scale with higher score more severe spasms)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in bowel function as measured by Neurogenic Bowel Dysfunction Scale</measure>
      <time_frame>Baseline to Immediately After Intervention</time_frame>
      <description>Symptom based questionnaire evaluating bowel dysfuntion and its impact on quality of life (score 0-47 with higher score indicating greater bowel dysfunction)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in bladder function as measured by Neurogenic Bladder Symptom Scale</measure>
      <time_frame>Baseline to Immediately After Intervention</time_frame>
      <description>Symptom based questionnaire evaluating bladder function and its impact on quality of lifehe Neurogenic Bladder Symptom Score (NBSS) is a validated 24 item questionnaire that measures bladder symptoms across 3 different domains: incontinence (scored 0-29), storage and voiding (scored 0-22), and consequences (scored 0-23); there is a single general urinary QOL question scored from 0 (pleased) to 4 (unhappy</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in balance/trunk control as measure by the Function in Sitting Test Spinal Cord Injury</measure>
      <time_frame>Baseline to Immediately After Intervention</time_frame>
      <description>Assesses static, proactive, and reactive balance as well as sensory integration. Each area assessed on scale of 0-4 with higher score indicating more independent trunk control.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">30</enrollment>
    <condition>Spinal Cord Injuries</condition>
    <arm_group>
      <arm_group_label>Exoskeleton+Transcutaneous Spinal Cord Stimulation</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Treatment in this group will involve walking overground using the assistance of an exoskeleton while receiving a therapeutic level of transcutaneous spinal cord stimulation (TSCS) thoracolumbar spinal cord areas. Focus will be on stepping at a high intensity throughout the session as measured by heart rate.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Exoskeleton+Sham Stimluation</arm_group_label>
      <arm_group_type>Sham Comparator</arm_group_type>
      <description>Treatment in this group will involve walking overground using the assistance of an exoskeleton while receiving a non-therapeutic level of stimulation (considered to be a sham). Focus will be on stepping at a high intensity throughout the session as measured by heart rate.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Exo + TSCS</intervention_name>
      <description>Participants will receive TSCS delivered with the ONWARD Lift system at 1ms using a 10kHz carrier frequency delivered at 30Hz, with an amplitude set for each participant based on their ability to increase voluntary movement output.</description>
      <arm_group_label>Exoskeleton+Transcutaneous Spinal Cord Stimulation</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Exo + Sham</intervention_name>
      <description>The ONWARD Lift system will also be used to deliver sham stimulation which will also be delivered at 1ms using a 10kHz carrier frequency delivered at 30Hz, and an amplitude of 1ma which has been used in other sham stimulation protocols and is not sufficient to induce activation of lumbosacral neuronal pools.</description>
      <arm_group_label>Exoskeleton+Sham Stimluation</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  &lt; 12 months post traumatic iSCI C4-T10 with signs of upper motor neuron injury&#xD;
  &#xD;
            -  AIS B, C or D classification&#xD;
  &#xD;
            -  18 years and older&#xD;
  &#xD;
            -  Height 5'0&quot; to 6'4&quot;&#xD;
  &#xD;
            -  Weight 220lbs or less&#xD;
  &#xD;
            -  Sufficient upper extremity strength to manage a stability aide&#xD;
  &#xD;
            -  Medical clearance for high intensity gait training&#xD;
  &#xD;
            -  Walking &lt;1.46 m/s&#xD;
  &#xD;
            -  Intact skin in on pelvis, lower extremities and back&#xD;
  &#xD;
            -  Passive range of motion at shoulders, trunk, hips, knees &amp; ankles within functional&#xD;
               limits&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Unstable or symptomatic cardiac or respiratory issues&#xD;
  &#xD;
            -  Recent history of fracture, contractures, pressure injury, deep vein thrombosis, or&#xD;
               other infection that might interfere with participation in study&#xD;
  &#xD;
            -  Received Botox injections to the lower extremities within the last six months&#xD;
  &#xD;
            -  Pregnancy&#xD;
  &#xD;
            -  Colostomy bag&#xD;
  &#xD;
            -  Cauda Equina injury&#xD;
  &#xD;
            -  Any other issue that in the opinion of the investigator would impact study&#xD;
               participation&#xD;
  &#xD;
            -  Non-English Speaking&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Katie Hays, DPT</last_name>
      <phone>303-789-8276</phone>
      <email>khays@craighospital.org</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Clare Morey, MA</last_name>
      <phone>303-789-8621</phone>
      <email>cmorey@craighospital.org</email>
    </overall_contact_backup>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 24, 2023</study_first_submitted>
    <study_first_submitted_qc>August 1, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 8, 2023</study_first_posted>
    <last_update_submitted>August 1, 2023</last_update_submitted>
    <last_update_submitted_qc>August 1, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <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>
    <!-- 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/NCT05982171
  org study id: IRB#2023877
  nct id: NCT05982171
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this clinical trial is to investigate the effects of transcutaneous spinal cord
        stimulation (TSCS) combined with exoskeleton training, as compared to exoskeleton training
        alone to improve motor function in individuals with incomplete spinal cord injury who are 12
        months or less post-injury. Participants will be randomly assigned to a treatment group
        (exoskeleton training with TSCS, or exoskeleton training without TSCS). Participants in both
        groups will undergo a baseline evaluation, then take part in 24, 1-hour training sessions at
        Craig Hospital. After the 24 sessions have concluded, participants will undergo a
        post-treatment evaluation as well as a follow-up evaluation four weeks after training is
        completed. Researchers will compare the two groups by evaluating the following areas:
  
          -  walking ability and speed
  
          -  lower extremity strength, activation, and spasticity
  
          -  trunk control
  
          -  bowel and bladder function
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Double (Participant, Outcomes Assessor)
  measure: Change in score on Walking Index for SCI (WISCI) II
  time frame: Baseline to Immediately After Intervention
  description: Assesses the amount of physical assistance/devices needed for walking following paralysis from SCI (scale of 0-20 with higher score indicating less need for assistance)
  measure: Change in walking speed as measured by the 10 Meter Walk Test
  time frame: Baseline to Immediately After Intervention
  description: Participants walk a ten-meter track; time to walk the middle six meters is recorded and converted to meters/second (speed)
  measure: Change in distance walked as measured by the 6 Meter Walk Test
  time frame: Baseline to Immediately After Intervention
  description: Measures distance walked (in meters) over 6 minute time period
  measure: Change in lower extremity strength as measured by Lower Extremity Motor Score (LEMS)
  time frame: Baseline to Post-treatment
  description: Assesses strength in 10 lower extremity muscle groups (each muscle scored 0-5 with higher score for greater strength; total score ranges 0-50.
  measure: Change in spasm frequency and severity as measured by Penn Spasm Frequency
  time frame: Baseline to Immediately After Intervention
  description: Self-report measure of perception of spasticity frequency (0 to 5 scale with higher score more frequent spasms) and severity (1-3 scale with higher score more severe spasms)
  measure: Change in bowel function as measured by Neurogenic Bowel Dysfunction Scale
  time frame: Baseline to Immediately After Intervention
  description: Symptom based questionnaire evaluating bowel dysfuntion and its impact on quality of life (score 0-47 with higher score indicating greater bowel dysfunction)
  measure: Change in bladder function as measured by Neurogenic Bladder Symptom Scale
  time frame: Baseline to Immediately After Intervention
  description: Symptom based questionnaire evaluating bladder function and its impact on quality of lifehe Neurogenic Bladder Symptom Score (NBSS) is a validated 24 item questionnaire that measures bladder symptoms across 3 different domains: incontinence (scored 0-29), storage and voiding (scored 0-22), and consequences (scored 0-23); there is a single general urinary QOL question scored from 0 (pleased) to 4 (unhappy
  measure: Change in balance/trunk control as measure by the Function in Sitting Test Spinal Cord Injury
  time frame: Baseline to Immediately After Intervention
  description: Assesses static, proactive, and reactive balance as well as sensory integration. Each area assessed on scale of 0-4 with higher score indicating more independent trunk control.
  arm group label: Exoskeleton+Transcutaneous Spinal Cord Stimulation
  arm group type: Experimental
  description: Treatment in this group will involve walking overground using the assistance of an exoskeleton while receiving a therapeutic level of transcutaneous spinal cord stimulation (TSCS) thoracolumbar spinal cord areas. Focus will be on stepping at a high intensity throughout the session as measured by heart rate.
  arm group label: Exoskeleton+Sham Stimluation
  arm group type: Sham Comparator
  description: Treatment in this group will involve walking overground using the assistance of an exoskeleton while receiving a non-therapeutic level of stimulation (considered to be a sham). Focus will be on stepping at a high intensity throughout the session as measured by heart rate.
  intervention type: Device
  intervention name: Exo + TSCS
  description: Participants will receive TSCS delivered with the ONWARD Lift system at 1ms using a 10kHz carrier frequency delivered at 30Hz, with an amplitude set for each participant based on their ability to increase voluntary movement output.
  arm group label: Exoskeleton+Transcutaneous Spinal Cord Stimulation
  intervention type: Device
  intervention name: Exo + Sham
  description: The ONWARD Lift system will also be used to deliver sham stimulation which will also be delivered at 1ms using a 10kHz carrier frequency delivered at 30Hz, and an amplitude of 1ma which has been used in other sham stimulation protocols and is not sufficient to induce activation of lumbosacral neuronal pools.
  arm group label: Exoskeleton+Sham Stimluation
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Katie Hays, DPT
  phone: 303-789-8276
  email: khays@craighospital.org
  last name: Clare Morey, MA
  phone: 303-789-8621
  email: cmorey@craighospital.org
  responsible party type: Sponsor
  mesh term: Spinal Cord Injuries
  mesh term: Wounds and Injuries
  sharing ipd: No