Efficacy of PoNS in Reducing Symptoms of Multiple Sclerosis

Helius Medical

Status

Completed

Conditions

Multiple Sclerosis

Treatments

Device: Portable Neuromodulation Stimulator

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT04496531

MS Pilot - Leonard, et al

Details and patient eligibility

About

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.

Full 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.

Enrollment

14 patients

Sex

All

Ages

28 to 62 years old

Volunteers

No Healthy Volunteers

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.