Efficacy of PoNS in Reducing Symptoms of Multiple Sclerosis

Not Applicable

Completed

• Conditions: Multiple Sclerosis
• Interventions: Device: Portable Neuromodulation Stimulator

• Registration Number: NCT04496531
• Lead Sponsor: Helius Medical Inc

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.

Study Timeline

• Study Start: 2014-12
• Primary Completion: 2016-08
• Study Completion: 2016-08
• Study First Submitted: 2020-07-29
• Study First Submitted QC: 2020-07-29
• Status Verified: 2020-08
• Study First Posted: 2020-08-03
• Last Update Submitted: 2020-08-03
• Last Update Posted: 2020-08-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham	Portable Neuromodulation Stimulator	Group members use a device providing a non-perceivable stimulus
Active	Portable Neuromodulation Stimulator	Active group members use a device providing perceivable electrical stimulation

Primary Outcome Measures

Name	Time	Method
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.