Efficacy of PoNS in Reducing Symptoms of Multiple Sclerosis

NCT04496531 | Completed

• 1 other identifier: MS Pilot - Leonard, et al
• Study Type: interventional
• Target: 14
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

• Dynamic Gait Index

  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.

  14 weeks

Study Arms (2)

Active

EXPERIMENTAL

Active group members use a device providing perceivable electrical stimulation

Device: Portable Neuromodulation Stimulator

Sham

SHAM COMPARATOR

Group members use a device providing a non-perceivable stimulus

Device: Portable Neuromodulation Stimulator

Interventions

Portable Neuromodulation Stimulator DEVICE

Also known as: PoNS

Active; Sham

Eligibility Criteria

• Age: 28 Years - 62 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Use of tobacco products;
• Oral health problems including abrasions, cuts, cold sores, piercings, or tissue inflammation in the oral cavity;
• Baseline EDSS \>6.

Sponsors & Collaborators

• Helius Medical Inc: lead
• McGill University: collaborator

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Therapists and other personnel (MR technicians, SOT and DGI administrators, Neuropsychologists etc.) were not informed as to which group a subject belonged. In order to maintain this blinding, both subjects and therapists were instructed not to discuss any details of the stimulus sensation with each other. Additionally, all subjects were instructed not to adjust the stimulus intensity in the presence of therapists. All questions about device use or the stimulation were to be addressed only to the PI
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 29, 2020
• First Posted: August 3, 2020
• Study Start: December 1, 2014
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: August 5, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share