<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/NCT04496531</url>
  </required_header>
  <id_info>
    <org_study_id>MS Pilot - Leonard, et al</org_study_id>
    <nct_id>NCT04496531</nct_id>
  </id_info>
  <brief_title>Efficacy of PoNS in Reducing Symptoms of Multiple Sclerosis</brief_title>
  <official_title>Examining the Efficacy of Non-invasive Neuromodulation in Reducing Symptoms of Multiple Sclerosis - a Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Helius Medical Inc</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>McGill University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Helius Medical Inc</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 purpose of this pilot study is to determine whether a program involving both in-lab and&#xD;
      at-home training using cranial nerve stimulation (CN-NINM) delivered via the tongue can&#xD;
      reduce symptoms of multiple sclerosis (MS) and improve movement control and therefore provide&#xD;
      ground work for a controlled clinical trial. The effects of the stimulation will be measured&#xD;
      using a variety of standardized tests of movement control and cognitive function, functional&#xD;
      brain imaging, and MS-specific surveys of your quality of life.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Fourteen MS patients, seven each in an active and a sham stimulation group are expected to&#xD;
      participate.&#xD;
&#xD;
      Participants will receive intensive physical therapy and working memory training for 14&#xD;
      weeks.&#xD;
&#xD;
      Functional magnetic resonance imaging (fMRI) using motor imagery and working-memory tasks&#xD;
      will be completed prior to and following therapy, as will be sensory organization tests&#xD;
      (SOT), motor performance measures, and neuropsychological assessment.&#xD;
&#xD;
      Prior to the start of CN-NINM training, each participant will undergo baseline evaluations&#xD;
      including structural and fMRI, balance tests (SOT), Dynamic Gait Index (DGI),&#xD;
      neuropsychological assessment (Handedness; Wechsler Abbreviated Scale of Intelligence (WASI)&#xD;
      Vocabulary and Matrix Reasoning; California Verbal Learning Test (CVLT)-11; D-Kefs Trails,&#xD;
      Color/Word and Verbal Fluency; Tower of London Second Edition; Ruff 2 and 7; Wechsler Adult&#xD;
      Intelligence Scale Fourth Edition (WAIS-IV) Letter-Number sequencing, Coding and Symbol&#xD;
      Search; Paced Auditory Serial Addition Test (PASAT); Leonard Tapping; and Grooved Pegboard).&#xD;
      In addition, the MS Impairment Scale, Fatigue Impact Scale, Cognitive Function Inventory for&#xD;
      MS, and Beck Depression and Anxiety questionnaires will be completed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 2014</start_date>
  <completion_date type="Actual">August 2016</completion_date>
  <primary_completion_date type="Actual">August 2016</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>
    <intervention_model_description>Fourteen MS patients, seven each in an active and a sham stimulation group, participated.&#xD;
Participants received intensive physical therapy and working memory training for 14 weeks. Functional magnetic resonance imaging (fMRI) using motor imagery and working-memory tasks were completed prior to and following therapy, as were sensory organization tests (SOT), motor performance measures, and neuropsychological assessment.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
    <masking_description>Therapists and other personnel (MR technicians, SOT and DGI administrators, Neuropsychologists etc.) were not informed as to which group a subject belonged. In order to maintain this blinding, both subjects and therapists were instructed not to discuss any details of the stimulus sensation with each other. Additionally, all subjects were instructed not to adjust the stimulus intensity in the presence of therapists. All questions about device use or the stimulation were to be addressed only to the PI</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Dynamic Gait Index</measure>
    <time_frame>14 weeks</time_frame>
    <description>Scores are based on a 4-point scale where: 3 = No gait dysfunction; 2 = Minimal impairment; 1 = Moderate impairment; and 0 = Severe impairment. The highest possible score was 24 points. Tasks include: Steady state walking; Walking with changing speeds; Walking with head turns both horizontally and vertically; Walking while stepping over and around obstacles; Pivoting while walking; and Stair climbing.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">14</enrollment>
  <condition>Multiple Sclerosis</condition>
  <arm_group>
    <arm_group_label>Active</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Active group members use a device providing perceivable electrical stimulation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Group members use a device providing a non-perceivable stimulus</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Portable Neuromodulation Stimulator</intervention_name>
    <arm_group_label>Active</arm_group_label>
    <arm_group_label>Sham</arm_group_label>
    <other_name>PoNS</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Relapsing/remitting or secondary progressive MS with balance and gait problems;&#xD;
&#xD;
          -  Recent EDSS score of 3.0 - 6.0;&#xD;
&#xD;
          -  Provided informed consent and willing to participate&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Use of tobacco products;&#xD;
&#xD;
          -  Oral health problems including abrasions, cuts, cold sores, piercings, or tissue&#xD;
             inflammation in the oral cavity;&#xD;
&#xD;
          -  Baseline EDSS &gt;6.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>28 Years</minimum_age>
    <maximum_age>62 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>July 29, 2020</study_first_submitted>
  <study_first_submitted_qc>July 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 3, 2020</study_first_posted>
  <last_update_submitted>August 3, 2020</last_update_submitted>
  <last_update_submitted_qc>August 3, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 5, 2020</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>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/NCT04496531
org study id: MS Pilot - Leonard, et al
nct id: NCT04496531
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this pilot study is to determine whether a program involving both in-lab and
      at-home training using cranial nerve stimulation (CN-NINM) delivered via the tongue can
      reduce symptoms of multiple sclerosis (MS) and improve movement control and therefore provide
      ground work for a controlled clinical trial. The effects of the stimulation will be measured
      using a variety of standardized tests of movement control and cognitive function, functional
      brain imaging, and MS-specific surveys of your quality of life.
Fourteen MS patients, seven each in an active and a sham stimulation group are expected to
      participate.

      Participants will receive intensive physical therapy and working memory training for 14
      weeks.

      Functional magnetic resonance imaging (fMRI) using motor imagery and working-memory tasks
      will be completed prior to and following therapy, as will be sensory organization tests
      (SOT), motor performance measures, and neuropsychological assessment.

      Prior to the start of CN-NINM training, each participant will undergo baseline evaluations
      including structural and fMRI, balance tests (SOT), Dynamic Gait Index (DGI),
      neuropsychological assessment (Handedness; Wechsler Abbreviated Scale of Intelligence (WASI)
      Vocabulary and Matrix Reasoning; California Verbal Learning Test (CVLT)-11; D-Kefs Trails,
      Color/Word and Verbal Fluency; Tower of London Second Edition; Ruff 2 and 7; Wechsler Adult
      Intelligence Scale Fourth Edition (WAIS-IV) Letter-Number sequencing, Coding and Symbol
      Search; Paced Auditory Serial Addition Test (PASAT); Leonard Tapping; and Grooved Pegboard).
      In addition, the MS Impairment Scale, Fatigue Impact Scale, Cognitive Function Inventory for
      MS, and Beck Depression and Anxiety questionnaires will be completed.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Fourteen MS patients, seven each in an active and a sham stimulation group, participated.
Participants received intensive physical therapy and working memory training for 14 weeks. Functional magnetic resonance imaging (fMRI) using motor imagery and working-memory tasks were completed prior to and following therapy, as were sensory organization tests (SOT), motor performance measures, and neuropsychological assessment.
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Outcomes Assessor)
masking description: Therapists and other personnel (MR technicians, SOT and DGI administrators, Neuropsychologists etc.) were not informed as to which group a subject belonged. In order to maintain this blinding, both subjects and therapists were instructed not to discuss any details of the stimulus sensation with each other. Additionally, all subjects were instructed not to adjust the stimulus intensity in the presence of therapists. All questions about device use or the stimulation were to be addressed only to the PI
measure: Dynamic Gait Index
time frame: 14 weeks
description: Scores are based on a 4-point scale where: 3 = No gait dysfunction; 2 = Minimal impairment; 1 = Moderate impairment; and 0 = Severe impairment. The highest possible score was 24 points. Tasks include: Steady state walking; Walking with changing speeds; Walking with head turns both horizontally and vertically; Walking while stepping over and around obstacles; Pivoting while walking; and Stair climbing.
arm group label: Active
arm group type: Experimental
description: Active group members use a device providing perceivable electrical stimulation
arm group label: Sham
arm group type: Sham Comparator
description: Group members use a device providing a non-perceivable stimulus
intervention type: Device
intervention name: Portable Neuromodulation Stimulator
arm group label: Active
arm group label: Sham
other name: PoNS
criteria: 
gender: All
minimum age: 28 Years
maximum age: 62 Years
healthy volunteers: No
responsible party type: Sponsor
mesh term: Multiple Sclerosis
mesh term: Sclerosis
sharing ipd: No