<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/NCT04486209</url>
  </required_header>
  <id_info>
    <org_study_id>Version MS_tSCS_v1</org_study_id>
    <nct_id>NCT04486209</nct_id>
  </id_info>
  <brief_title>Non-invasive Spinal Cord Stimulation for Spasticity Control and Augmentation of Voluntary Motor Control in Individuals With Multiple Sclerosis</brief_title>
  <acronym>noSpasMS</acronym>
  <official_title>Non-invasive Spinal Cord Stimulation for Spasticity Control and Augmentation of Voluntary Motor Control in Individuals With Multiple Sclerosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical University of Vienna</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Neurological Center, Otto Wagner Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Medical University of Vienna</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>
      Epidural spinal cord stimulation (SCS) is currently regarded as one of the most promising&#xD;
      intervention methods to improve motor function in individuals with severe spinal cord injury.&#xD;
      In parallel, an increasing number of studies is suggesting that noninvasive SCS can improve&#xD;
      spasticity and residual motor control in the same subject population. The present study&#xD;
      explores whether single sessions of noninvasive SCS would improve walking performance and&#xD;
      ameliorate spasticity in individuals with multiple sclerosis.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 27, 2017</start_date>
  <completion_date type="Actual">July 2, 2020</completion_date>
  <primary_completion_date type="Actual">July 2, 2020</primary_completion_date>
  <phase>Early Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Modified Ashworth Scale</measure>
    <time_frame>24 hours</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>10-m walk test</measure>
    <time_frame>24 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>2-min walk test</measure>
    <time_frame>24 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Timed up an go test</measure>
    <time_frame>24 hours</time_frame>
  </secondary_outcome>
  <enrollment type="Actual">15</enrollment>
  <condition>Multiple Sclerosis</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>transcutaneous spinal cord stimulation</intervention_name>
    <description>electrical stimulation of the lumbosacral spinal cord through surface electrodes</description>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  confirmed diagnosis of relapsing-remitting, primary- or secondary-progressive MS&#xD;
&#xD;
          -  lower-limb spasticity&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  acute relapse of MS&#xD;
&#xD;
          -  other neuromuscular diseases&#xD;
&#xD;
          -  active and passive implants at vertebral level T9 or caudally&#xD;
&#xD;
          -  dermatological issues at stimulation site&#xD;
&#xD;
          -  pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Medical University of Vienna</name>
      <address>
        <city>Vienna</city>
        <zip>1090</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Austria</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 17, 2020</study_first_submitted>
  <study_first_submitted_qc>July 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 24, 2020</study_first_posted>
  <last_update_submitted>July 22, 2020</last_update_submitted>
  <last_update_submitted_qc>July 22, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 24, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Medical University of Vienna</investigator_affiliation>
    <investigator_full_name>Ursula Hofstoetter</investigator_full_name>
    <investigator_title>Senior researcher</investigator_title>
  </responsible_party>
  <keyword>neuromodulation</keyword>
  <keyword>spinal cord stimulation</keyword>
  <keyword>walking function</keyword>
  <keyword>spasticity</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Muscle Spasticity</mesh_term>
    <mesh_term>Multiple Sclerosis</mesh_term>
    <mesh_term>Sclerosis</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/NCT04486209
org study id: Version MS_tSCS_v1
nct id: NCT04486209
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Epidural spinal cord stimulation (SCS) is currently regarded as one of the most promising
      intervention methods to improve motor function in individuals with severe spinal cord injury.
      In parallel, an increasing number of studies is suggesting that noninvasive SCS can improve
      spasticity and residual motor control in the same subject population. The present study
      explores whether single sessions of noninvasive SCS would improve walking performance and
      ameliorate spasticity in individuals with multiple sclerosis.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Modified Ashworth Scale
time frame: 24 hours
measure: 10-m walk test
time frame: 24 hours
measure: 2-min walk test
time frame: 24 hours
measure: Timed up an go test
time frame: 24 hours
intervention type: Device
intervention name: transcutaneous spinal cord stimulation
description: electrical stimulation of the lumbosacral spinal cord through surface electrodes
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
facility: 
country: Austria
responsible party type: Principal Investigator
investigator affiliation: Medical University of Vienna
investigator full name: Ursula Hofstoetter
investigator title: Senior researcher
mesh term: Muscle Spasticity
mesh term: Multiple Sclerosis
mesh term: Sclerosis
sharing ipd: No