<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/NCT04498039</url>
  </required_header>
  <id_info>
    <org_study_id>H2008-0252</org_study_id>
    <nct_id>NCT04498039</nct_id>
  </id_info>
  <brief_title>Reducing Symptoms of Multiple Sclerosis Using Non-invasive Neuromodulation</brief_title>
  <official_title>Reducing Symptoms of Multiple Sclerosis Using Non-invasive Neuromodulation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Wisconsin, Madison</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Wisconsin, Madison</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study sought to examine the effect of targeted physical therapy with and without cranial&#xD;
      nerve non-invasive neuromodulation (CN-NINM), on the walking ability of people with MS who&#xD;
      exhibited a dysfunctional gait.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background: This study sought to examine the effect of targeted physical therapy with and&#xD;
      without cranial nerve non-invasive neuromodulation (CN-NINM), on the walking ability of&#xD;
      people with MS who exhibited a dysfunctional gait. The investigators hypothesized that&#xD;
      subjects who received electrical stimulation would have greater improvement than those who&#xD;
      had a control device after a 14-week intervention. Gait disturbance is a common problem for&#xD;
      people with multiple sclerosis (MS). The investigators have developed an effective&#xD;
      rehabilitative strategy using neuromodulation of the cranial nerves via electrical&#xD;
      stimulation of the tongue to enhance the plasticity of the brain.&#xD;
&#xD;
      Methods: The study is a within-subject blinded randomized control design. Twenty chronic MS&#xD;
      subjects with an identified gait disturbance were assigned to either an active or control&#xD;
      group. Both groups completed a 14-week intervention program using a standardized combination&#xD;
      of exercise and a device that provided electrical stimulation to the tongue. Those in the&#xD;
      active group received electrical stimulation on the tongue that they could perceive. Those in&#xD;
      the control group used a device that did not provide a physiologically significant stimulus&#xD;
      and was not perceivable. Subjects were assessed with the Dynamic Gait Index (DGI).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 2009</start_date>
  <completion_date type="Actual">May 2011</completion_date>
  <primary_completion_date type="Actual">May 2011</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>The study is a within-subject blinded randomized control design. Twenty chronic MS subjects with an identified gait disturbance were assigned to either an active or control group. Both groups completed a 14-week intervention program using a standardized combination of exercise and a device that provided electrical stimulation to the tongue. Those in the active group received electrical stimulation on the tongue that they could perceive.&#xD;
Those in the control group used a device that did not provide a physiologically significant stimulus and was not perceivable. Subjects were assessed with the Dynamic Gait Index (DGI).</intervention_model_description>
    <primary_purpose>Device Feasibility</primary_purpose>
    <masking>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Dynamic Gait Index DGI</measure>
    <time_frame>14 weeks</time_frame>
    <description>The Dynamic Gait Index (DGI) is a clinician-scored index of 8 gait tasks which was developed as a clinical tool for assessing gait, balance, and fall risk by evaluating dynamic balance. Tasks include steady state walking, changing speeds while walking, walking with horizontal and vertical head turns, walking around and stepping over objects, walking to a pivot turn and stop, and traversing stairs. The maximum total individual score is 24 points (0-3 on each task), with higher scores indicating better function. A 4-point change in DGI would require an improvement of at least one level on four of 8 tasks, or multiple levels of improvement on several tasks. Thus, a 4-point change represents a clinically significant difference that is generally measurable without excessive variability.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Multiple Sclerosis</condition>
  <arm_group>
    <arm_group_label>Active</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Electrical stimulation to the tongue is delivered via the Portable Neuromodulation Stimulator (PoNS™) device . The PoNS™ device is held in place lightly by the lips and teeth around a rectangular tab that goes into the mouth and rests on the anterior, superior part of the tongue. Active subjects will be able to feel the sensation.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Electrical stimulation to the tongue will be delivered via the Portable Neuromodulation Stimulator (PoNS™) device . The PoNS™ device is held in place lightly by the lips and teeth around a rectangular tab that goes into the mouth and rests on the anterior, superior part of the tongue. Control subjects will be informed that while they may not feel the electrotactile stimulation, they are in-fact receiving a low level signal.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Portable Neuromodulation Stimulator</intervention_name>
    <description>Examining the effect of targeted physical therapy with and without cranial nerve non-invasive neuromodulation (CN-NINM), on the walking ability of people with MS who exhibit a dysfunctional gait. Adopting a rehabilitative strategy using neuromodulation of the cranial nerves via electrical stimulation of the tongue to enhance the plasticity of the brain.</description>
    <arm_group_label>Active</arm_group_label>
    <arm_group_label>Control</arm_group_label>
    <other_name>PoNS</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        All subjects are initially evaluated for inclusion/exclusion on the Kurtzke Expanded&#xD;
        Disability Status Scale (EDSS), a test typically administered by their healthcare provider&#xD;
        as an ongoing part of standard therapy for M.S&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  Relapsing remitting MS (&quot;RRMS&quot;), primary progressive MS (&quot;PPMS&quot;), or secondary&#xD;
             progressive MS (&quot;SPMS&quot;) without relapse within 6 months of enrollment;&#xD;
&#xD;
          -  EDSS score of 3.0 - 6.0 ;&#xD;
&#xD;
          -  No changes in medication within 3 months of enrollment;&#xD;
&#xD;
          -  Ability to walk 20 minutes on a treadmill (with handrail support as needed) without&#xD;
             rest;&#xD;
&#xD;
          -  Provided informed consent and willing to participate.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        • Major co-morbidities, especially other neurological disorders, uncontrolled pain,&#xD;
        hypertension, diabetes, or oral health problems&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mitchell E Tyler, P.E, M.S</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Wisconsin, Madison</affiliation>
  </overall_official>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>July 27, 2020</study_first_submitted>
  <study_first_submitted_qc>July 30, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 4, 2020</study_first_posted>
  <last_update_submitted>August 5, 2020</last_update_submitted>
  <last_update_submitted_qc>August 5, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 7, 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/NCT04498039
org study id: H2008-0252
nct id: NCT04498039
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
This study sought to examine the effect of targeted physical therapy with and without cranial
      nerve non-invasive neuromodulation (CN-NINM), on the walking ability of people with MS who
      exhibited a dysfunctional gait.
Background: This study sought to examine the effect of targeted physical therapy with and
      without cranial nerve non-invasive neuromodulation (CN-NINM), on the walking ability of
      people with MS who exhibited a dysfunctional gait. The investigators hypothesized that
      subjects who received electrical stimulation would have greater improvement than those who
      had a control device after a 14-week intervention. Gait disturbance is a common problem for
      people with multiple sclerosis (MS). The investigators have developed an effective
      rehabilitative strategy using neuromodulation of the cranial nerves via electrical
      stimulation of the tongue to enhance the plasticity of the brain.

      Methods: The study is a within-subject blinded randomized control design. Twenty chronic MS
      subjects with an identified gait disturbance were assigned to either an active or control
      group. Both groups completed a 14-week intervention program using a standardized combination
      of exercise and a device that provided electrical stimulation to the tongue. Those in the
      active group received electrical stimulation on the tongue that they could perceive. Those in
      the control group used a device that did not provide a physiologically significant stimulus
      and was not perceivable. Subjects were assessed with the Dynamic Gait Index (DGI).
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: The study is a within-subject blinded randomized control design. Twenty chronic MS subjects with an identified gait disturbance were assigned to either an active or control group. Both groups completed a 14-week intervention program using a standardized combination of exercise and a device that provided electrical stimulation to the tongue. Those in the active group received electrical stimulation on the tongue that they could perceive.
Those in the control group used a device that did not provide a physiologically significant stimulus and was not perceivable. Subjects were assessed with the Dynamic Gait Index (DGI).
primary purpose: Device Feasibility
masking: Triple (Participant, Care Provider, Outcomes Assessor)
measure: Dynamic Gait Index DGI
time frame: 14 weeks
description: The Dynamic Gait Index (DGI) is a clinician-scored index of 8 gait tasks which was developed as a clinical tool for assessing gait, balance, and fall risk by evaluating dynamic balance. Tasks include steady state walking, changing speeds while walking, walking with horizontal and vertical head turns, walking around and stepping over objects, walking to a pivot turn and stop, and traversing stairs. The maximum total individual score is 24 points (0-3 on each task), with higher scores indicating better function. A 4-point change in DGI would require an improvement of at least one level on four of 8 tasks, or multiple levels of improvement on several tasks. Thus, a 4-point change represents a clinically significant difference that is generally measurable without excessive variability.
arm group label: Active
arm group type: Experimental
description: Electrical stimulation to the tongue is delivered via the Portable Neuromodulation Stimulator (PoNS™) device . The PoNS™ device is held in place lightly by the lips and teeth around a rectangular tab that goes into the mouth and rests on the anterior, superior part of the tongue. Active subjects will be able to feel the sensation.
arm group label: Control
arm group type: Sham Comparator
description: Electrical stimulation to the tongue will be delivered via the Portable Neuromodulation Stimulator (PoNS™) device . The PoNS™ device is held in place lightly by the lips and teeth around a rectangular tab that goes into the mouth and rests on the anterior, superior part of the tongue. Control subjects will be informed that while they may not feel the electrotactile stimulation, they are in-fact receiving a low level signal.
intervention type: Device
intervention name: Portable Neuromodulation Stimulator
description: Examining the effect of targeted physical therapy with and without cranial nerve non-invasive neuromodulation (CN-NINM), on the walking ability of people with MS who exhibit a dysfunctional gait. Adopting a rehabilitative strategy using neuromodulation of the cranial nerves via electrical stimulation of the tongue to enhance the plasticity of the brain.
arm group label: Active
arm group label: Control
other name: PoNS
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Mitchell E Tyler, P.E, M.S
role: Principal Investigator
affiliation: University of Wisconsin, Madison
responsible party type: Sponsor
mesh term: Multiple Sclerosis
mesh term: Sclerosis
sharing ipd: No