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Efficacy of PoNS in Reducing Symptoms of Multiple Sclerosis

Sponsor
Helius Medical Inc (Industry)
Overall Status
Completed
CT.gov ID
NCT04496531
Collaborator
McGill University (Other)
14
Enrollment
2
Arms
20
Actual Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Portable Neuromodulation Stimulator
 N/A

Detailed Description

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
14 participants
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.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.
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
Primary Purpose:
Treatment
Official Title:
Examining the Efficacy of Non-invasive Neuromodulation in Reducing Symptoms of Multiple Sclerosis - a Pilot Study
Actual Study Start Date :
Dec 1, 2014
Actual Primary Completion Date :
Aug 1, 2016
Actual Study Completion Date :
Aug 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: Active

Active group members use a device providing perceivable electrical stimulation

Device: Portable Neuromodulation Stimulator
Other Names:
  • PoNS

    		•
    Sham Comparator: Sham

    Group members use a device providing a non-perceivable stimulus

    Device: Portable Neuromodulation Stimulator
    Other Names:
  • PoNS

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Dynamic Gait Index [14 weeks]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    28 Years to 62 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Relapsing/remitting or secondary progressive MS with balance and gait problems;

    • Recent EDSS score of 3.0 - 6.0;

    • Provided informed consent and willing to participate

    Exclusion Criteria:

    • Use of tobacco products;

    • Oral health problems including abrasions, cuts, cold sores, piercings, or tissue inflammation in the oral cavity;

    • Baseline EDSS >6.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Helius Medical Inc
    • McGill University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Helius Medical Inc
    ClinicalTrials.gov Identifier:
    NCT04496531
    Other Study ID Numbers:
    • MS Pilot - Leonard, et al
    First Posted:
    Aug 3, 2020
    Last Update Posted:
    Aug 5, 2020
    Last Verified:
    Aug 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Multiple Sclerosis
    Sclerosis

    Study Results

    No Results Posted as of Aug 5, 2020