Efficacy of PoNS in Reducing Symptoms of Multiple Sclerosis

NCT ID: NCT04496531

Last Updated: 2020-08-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-12-31
• Study Completion Date: 2016-08-31

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.

Conditions

Multiple Sclerosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Active

Active group members use a device providing perceivable electrical stimulation

Group Type: EXPERIMENTAL

Portable Neuromodulation Stimulator

Intervention Type: DEVICE

Sham

Group members use a device providing a non-perceivable stimulus

Group Type: SHAM_COMPARATOR

Portable Neuromodulation Stimulator

Intervention Type: DEVICE

Interventions

Portable Neuromodulation Stimulator

Intervention Type: DEVICE

Other Intervention Names

PoNS

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.

• Minimum Eligible Age: 28 Years
• Maximum Eligible Age: 62 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

McGill University

OTHER

Sponsor Role: collaborator

Helius Medical Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

MS Pilot - Leonard, et al

Identifier Type: -

Identifier Source: org_study_id