<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/NCT04467437</url>
  </required_header>
  <id_info>
    <org_study_id>STUDY00008896</org_study_id>
    <nct_id>NCT04467437</nct_id>
  </id_info>
  <brief_title>Transcutaneous Stimulation for Neurological Populations</brief_title>
  <official_title>Transcutaneous Spinal Stimulation With Intensive Gait Training for Individuals With Neurologic Conditions</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Washington</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Seattle Children's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Washington</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the study is to evaluate whether non-invasive stimulation over the spinal cord&#xD;
      at the neck and/or lower back can improve walking function for people with neurologic&#xD;
      conditions. Spinal stimulation has been used extensively for individuals with spinal cord&#xD;
      injury, and has demonstrated improvements in function. This study will extend this work to&#xD;
      other neurologic conditions, such as cerebral palsy and stroke, that also demonstrate similar&#xD;
      impairments as spinal cord injury.&#xD;
&#xD;
      The primary aims of this study are to:&#xD;
&#xD;
      Aim 1: Evaluate impact of spinal stimulation on spasticity and locomotor function.&#xD;
&#xD;
      Aim 2: Investigate participant perceptions of spinal stimulation.&#xD;
&#xD;
      The investigators will be using a cross-over design study to compare intensive training only&#xD;
      to intensive training combined with spinal stimulation. After an initial baseline period of&#xD;
      up to 4 weeks (Phase I). Participants will have their first intervention phase of the study&#xD;
      (Phase II). This will involve either intensive training only (Condition A) or intensive&#xD;
      training combined with spinal stimulation (Condition B). This will be followed by a washout&#xD;
      period with no intervention (Phase III) and then the second intervention phase (Phase IV).&#xD;
      The second intervention phase will involve either Condition A or Condition B, whichever the&#xD;
      participants did not received during Phase II. Phases II-IV will each last up to 8 weeks.&#xD;
      After the intervention period is complete, the participant will be asked to come for&#xD;
      follow-up visits up to 3 months after the intervention phases are completed (Phase V).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 1, 2021</start_date>
  <completion_date type="Anticipated">December 2024</completion_date>
  <primary_completion_date type="Anticipated">August 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>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline - Six Minute Walk Test</measure>
    <time_frame>Measurements at baseline and repeated measurements once every two weeks throughout the study, an average of 10 months.</time_frame>
    <description>Measure of walking ability. The distance is reported in meters.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline - Ten Meter Walk Test</measure>
    <time_frame>Measurements at baseline and repeated measurements once every two weeks throughout the study, an average of 10 months.</time_frame>
    <description>The measure of walking ability at fast and self-selected speeds. The walking speed is reported as meters per second.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from baseline - Kinetic and kinematic gait analysis using three dimensional camera system</measure>
    <time_frame>Measurements at baseline and repeated measurements once every two months throughout the study, an average of 10 months.</time_frame>
    <description>Measurement of leg function and walking ability. Joint angle is reported in angle degrees, and velocity is reported in meters per second. Kinematic analysis will able to used to measure gait coordination and spatiotemporal outcomes, such as step length and step time.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline - Electromyography recording of lower extremity muscles</measure>
    <time_frame>Measurements at baseline and repeated measurements once every two months throughout the study, an average of 10 months.</time_frame>
    <description>Measurement of muscle and nerve functions. The muscle activities are reported in micro-volts.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline - Gait Outcomes Assessment List</measure>
    <time_frame>Measurements at baseline and repeated measurements once every two months throughout the study, an average of 10 months.</time_frame>
    <description>The patient-reported outcome measure for ambulatory children with cerebral palsy. The Gait Outcomes Assessment List comprises 48 items distributed across 7 subscales and spans all domains of the International Classification of Functioning, Disability, and Health. The score range is between 0 and 100. The higher scores mean a better outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline - Timed Up and Go</measure>
    <time_frame>Measurements at baseline and repeated measurements once every two months throughout the study, an average of 10 months.</time_frame>
    <description>Measurement of mobility and fall risk. The time to complete the test is recorded in seconds.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline - Modified Ashworth and Tardieu Scales</measure>
    <time_frame>Measurements at baseline and repeated measurements once every two weeks throughout the study, an average of 10 months.</time_frame>
    <description>Measurement of spasticity in muscles. The score range is between 0 and 5. The lower scores mean a better outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline - Patient-Reported Outcomes Measurement Information System Pediatric Profile</measure>
    <time_frame>Measurements at baseline and repeated measurements once every two months throughout the study, an average of 10 months.</time_frame>
    <description>Includes six domains. These are depression, Anxiety, Physical Function-Mobility, Pain Interference, Fatigue, and Peer Relationships. Each domain contains 8 items, along with a single item on Pain Intensity scored between 0 to 10.&#xD;
The score range for each domain is between 1 and 5. The lower scores mean a better outcome.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Neurological Disorder</condition>
  <condition>Cerebral Palsy</condition>
  <arm_group>
    <arm_group_label>Intensive Training Only</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Physical and gait training that targets rehabilitation of walking function.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intensive Training Combined with Spinal Stimulation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Transcutaneous spinal stimulation combined with physical and gait training that targets rehabilitation of walking function.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Gait Training</intervention_name>
    <description>Training that targets rehabilitation of walking function</description>
    <arm_group_label>Intensive Training Combined with Spinal Stimulation</arm_group_label>
    <arm_group_label>Intensive Training Only</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Transcutaneous Spinal Stimulation</intervention_name>
    <description>Non-invasive electrical stimulation of the spinal cord over the skin combined with gait training</description>
    <arm_group_label>Intensive Training Combined with Spinal Stimulation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  have a neurologic condition&#xD;
&#xD;
          -  can walk 20 yards, with or without an assistive device&#xD;
&#xD;
          -  have stable medical condition&#xD;
&#xD;
          -  are capable of performing simple cued motor tasks and who can follow 2-3 step commands&#xD;
&#xD;
          -  have ability to attend up to 5 sessions per week physical therapy sessions and testing&#xD;
             activities&#xD;
&#xD;
          -  have adequate social support to be able to participate in training and assessment&#xD;
             sessions, up to 5 sessions per week, for the duration of up to 11 months within the&#xD;
             study period.&#xD;
&#xD;
          -  who are volunteering to be involved in this study&#xD;
&#xD;
          -  can read and speak English&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  have significant medical disease; including uncontrolled systemic hypertension with&#xD;
             values above 170/100 mmHg; cardiac or pulmonary disease; uncorrected coagulation&#xD;
             abnormalities or need for therapeutic anticoagulation.&#xD;
&#xD;
          -  have cardiovascular or musculoskeletal disease or injury that would prevent full&#xD;
             participation in physical therapy intervention&#xD;
&#xD;
          -  have a history of uncontrolled seizures&#xD;
&#xD;
          -  have unhealed fracture or other musculoskeletal impairment that might interfere with&#xD;
             lower extremity rehabilitation or testing activities&#xD;
&#xD;
          -  are dependent on ventilation support&#xD;
&#xD;
          -  have implanted stimulator (e.g. epidural stimulator, vagus nerve stimulator,&#xD;
             pacemaker, cochlear implant, etc) or drug delivery device (e.g. baclofen pump)&#xD;
&#xD;
          -  have history of orthopedic surgery in lower extremities or neurosurgery that may be a&#xD;
             confounding factor for interpretation of the results (such as tendon transfer, tendon&#xD;
             or muscle lengthening for spasticity management, injection therapies to lower&#xD;
             extremity muscles, etc.) in last 12 months&#xD;
&#xD;
          -  have established osteoporosis and taking medication for osteoporosis treatment.&#xD;
&#xD;
          -  have rheumatic diseases (rheumatoid arthritis, systemic lupus erythematosus, etc.)&#xD;
&#xD;
          -  have active cancer&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>10 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Katherine M Steele, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Washington</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Siddhi R Shrivastav, BPTh, MS</last_name>
    <phone>973-444-1940</phone>
    <email>siddhis@uw.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Chet T Moritz, PhD</last_name>
    <phone>206-221-2842</phone>
    <email>ctmoritz@uw.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>University of Washington</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98115</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Siddhi R Shrivastav</last_name>
      <email>siddhis@uw.edu</email>
    </contact>
    <contact_backup>
      <last_name>Chet T Moritz</last_name>
      <email>ctmoritz@uw.edu</email>
    </contact_backup>
    <investigator>
      <last_name>Chet T Moritz, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Katherine M Steele, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>July 7, 2020</study_first_submitted>
  <study_first_submitted_qc>July 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 13, 2020</study_first_posted>
  <last_update_submitted>November 14, 2022</last_update_submitted>
  <last_update_submitted_qc>November 14, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 18, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Washington</investigator_affiliation>
    <investigator_full_name>Chet Moritz</investigator_full_name>
    <investigator_title>Associate Professor of Electrical &amp; Computer Engineering and Rehabilitation Medicine</investigator_title>
  </responsible_party>
  <keyword>Spinal Electrical Stimulation</keyword>
  <keyword>Treadmill Training</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cerebral Palsy</mesh_term>
    <mesh_term>Nervous System Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT04467437
org study id: STUDY00008896
nct id: NCT04467437
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
The purpose of the study is to evaluate whether non-invasive stimulation over the spinal cord
      at the neck and/or lower back can improve walking function for people with neurologic
      conditions. Spinal stimulation has been used extensively for individuals with spinal cord
      injury, and has demonstrated improvements in function. This study will extend this work to
      other neurologic conditions, such as cerebral palsy and stroke, that also demonstrate similar
      impairments as spinal cord injury.

      The primary aims of this study are to:

      Aim 1: Evaluate impact of spinal stimulation on spasticity and locomotor function.

      Aim 2: Investigate participant perceptions of spinal stimulation.

      The investigators will be using a cross-over design study to compare intensive training only
      to intensive training combined with spinal stimulation. After an initial baseline period of
      up to 4 weeks (Phase I). Participants will have their first intervention phase of the study
      (Phase II). This will involve either intensive training only (Condition A) or intensive
      training combined with spinal stimulation (Condition B). This will be followed by a washout
      period with no intervention (Phase III) and then the second intervention phase (Phase IV).
      The second intervention phase will involve either Condition A or Condition B, whichever the
      participants did not received during Phase II. Phases II-IV will each last up to 8 weeks.
      After the intervention period is complete, the participant will be asked to come for
      follow-up visits up to 3 months after the intervention phases are completed (Phase V).
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change from baseline - Six Minute Walk Test
time frame: Measurements at baseline and repeated measurements once every two weeks throughout the study, an average of 10 months.
description: Measure of walking ability. The distance is reported in meters.
measure: Change from baseline - Ten Meter Walk Test
time frame: Measurements at baseline and repeated measurements once every two weeks throughout the study, an average of 10 months.
description: The measure of walking ability at fast and self-selected speeds. The walking speed is reported as meters per second.
measure: Change from baseline - Kinetic and kinematic gait analysis using three dimensional camera system
time frame: Measurements at baseline and repeated measurements once every two months throughout the study, an average of 10 months.
description: Measurement of leg function and walking ability. Joint angle is reported in angle degrees, and velocity is reported in meters per second. Kinematic analysis will able to used to measure gait coordination and spatiotemporal outcomes, such as step length and step time.
measure: Change from baseline - Electromyography recording of lower extremity muscles
time frame: Measurements at baseline and repeated measurements once every two months throughout the study, an average of 10 months.
description: Measurement of muscle and nerve functions. The muscle activities are reported in micro-volts.
measure: Change from baseline - Gait Outcomes Assessment List
time frame: Measurements at baseline and repeated measurements once every two months throughout the study, an average of 10 months.
description: The patient-reported outcome measure for ambulatory children with cerebral palsy. The Gait Outcomes Assessment List comprises 48 items distributed across 7 subscales and spans all domains of the International Classification of Functioning, Disability, and Health. The score range is between 0 and 100. The higher scores mean a better outcome.
measure: Change from baseline - Timed Up and Go
time frame: Measurements at baseline and repeated measurements once every two months throughout the study, an average of 10 months.
description: Measurement of mobility and fall risk. The time to complete the test is recorded in seconds.
measure: Change from baseline - Modified Ashworth and Tardieu Scales
time frame: Measurements at baseline and repeated measurements once every two weeks throughout the study, an average of 10 months.
description: Measurement of spasticity in muscles. The score range is between 0 and 5. The lower scores mean a better outcome.
measure: Change from baseline - Patient-Reported Outcomes Measurement Information System Pediatric Profile
time frame: Measurements at baseline and repeated measurements once every two months throughout the study, an average of 10 months.
description: Includes six domains. These are depression, Anxiety, Physical Function-Mobility, Pain Interference, Fatigue, and Peer Relationships. Each domain contains 8 items, along with a single item on Pain Intensity scored between 0 to 10.
The score range for each domain is between 1 and 5. The lower scores mean a better outcome.
arm group label: Intensive Training Only
arm group type: Active Comparator
description: Physical and gait training that targets rehabilitation of walking function.
arm group label: Intensive Training Combined with Spinal Stimulation
arm group type: Active Comparator
description: Transcutaneous spinal stimulation combined with physical and gait training that targets rehabilitation of walking function.
intervention type: Other
intervention name: Gait Training
description: Training that targets rehabilitation of walking function
arm group label: Intensive Training Combined with Spinal Stimulation
arm group label: Intensive Training Only
intervention type: Device
intervention name: Transcutaneous Spinal Stimulation
description: Non-invasive electrical stimulation of the spinal cord over the skin combined with gait training
arm group label: Intensive Training Combined with Spinal Stimulation
criteria: 
gender: All
minimum age: 10 Years
maximum age: 70 Years
healthy volunteers: No
last name: Katherine M Steele, PhD
role: Principal Investigator
affiliation: University of Washington
last name: Siddhi R Shrivastav, BPTh, MS
phone: 973-444-1940
email: siddhis@uw.edu
last name: Chet T Moritz, PhD
phone: 206-221-2842
email: ctmoritz@uw.edu
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Washington
investigator full name: Chet Moritz
investigator title: Associate Professor of Electrical & Computer Engineering and Rehabilitation Medicine
mesh term: Cerebral Palsy
mesh term: Nervous System Diseases
sharing ipd: No