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OpenTrials
Completed

NCT Number: NCT04496531

Efficacy of PoNS in Reducing Symptoms of Multiple Sclerosis

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Portable Neuromodulation Stimulator

Device

Other names: PoNS

Primary outcomes

  1. Dynamic Gait Index

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Helius Medical Inc

Industry

Collaborators

  • McGill University

Registry information

Official study title

Examining the Efficacy of Non-invasive Neuromodulation in Reducing Symptoms of Multiple Sclerosis - a Pilot Study

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Aug 3, 2020
Registry last updated
Aug 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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