Clinical trial NCT04496531: Efficacy of PoNS in Reducing Symptoms of Multiple Sclerosis
Official title: Examining the Efficacy of Non-invasive Neuromodulation in Reducing Symptoms of Multiple Sclerosis - a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Lead sponsor: Helius Medical Inc
Sponsor class: INDUSTRY
Collaborators: name: McGill University
First posted: 2020-08-03
Enrollment: 14
Sex: ALL
Minimum age (years): 28
Maximum age (years): 62
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Dynamic Gait Index
timeFrame: 14 weeks
Secondary outcomes:
Other outcomes:
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