Reducing Symptoms of Multiple Sclerosis Using Non-invasive Neuromodulation

This study sought to examine the effect of targeted physical therapy with and without cranial nerve non-invasive neuromodulation (CN-NINM), on the walking ability of people with MS who exhibited a dysfunctional gait.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

Background: This study sought to examine the effect of targeted physical therapy with and without cranial nerve non-invasive neuromodulation (CN-NINM), on the walking ability of people with MS who exhibited a dysfunctional gait. The investigators hypothesized that subjects who received electrical stimulation would have greater improvement than those who had a control device after a 14-week intervention. Gait disturbance is a common problem for people with multiple sclerosis (MS). The investigators have developed an effective rehabilitative strategy using neuromodulation of the cranial nerves via electrical stimulation of the tongue to enhance the plasticity of the brain.

Methods: The study is a within-subject blinded randomized control design. Twenty chronic MS subjects with an identified gait disturbance were assigned to either an active or control group. Both groups completed a 14-week intervention program using a standardized combination of exercise and a device that provided electrical stimulation to the tongue. Those in the active group received electrical stimulation on the tongue that they could perceive. Those in the control group used a device that did not provide a physiologically significant stimulus and was not perceivable. Subjects were assessed with the Dynamic Gait Index (DGI).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

All subjects are initially evaluated for inclusion/exclusion on the Kurtzke Expanded Disability Status Scale (EDSS), a test typically administered by their healthcare provider as an ongoing part of standard therapy for M.S

Inclusion criteria

Relapsing remitting MS ("RRMS"), primary progressive MS ("PPMS"), or secondary progressive MS ("SPMS") without relapse within 6 months of enrollment;
EDSS score of 3.0 - 6.0 ;
No changes in medication within 3 months of enrollment;
Ability to walk 20 minutes on a treadmill (with handrail support as needed) without rest;
Provided informed consent and willing to participate.

Exclusion criteria

Major co-morbidities, especially other neurological disorders, uncontrolled pain, hypertension, diabetes, or oral health problems

Treatment and study plan

Portable Neuromodulation Stimulator

Device

Examining the effect of targeted physical therapy with and without cranial nerve non-invasive neuromodulation (CN-NINM), on the walking ability of people with MS who exhibit a dysfunctional gait. Adopting a rehabilitative strategy using neuromodulation of the cranial nerves via electrical stimulation of the tongue to enhance the plasticity of the brain.

Other names: PoNS

Primary outcomes

Dynamic Gait Index DGI

Time frame: 14 weeks

The Dynamic Gait Index (DGI) is a clinician-scored index of 8 gait tasks which was developed as a clinical tool for assessing gait, balance, and fall risk by evaluating dynamic balance. Tasks include steady state walking, changing speeds while walking, walking with horizontal and vertical head turns, walking around and stepping over objects, walking to a pivot turn and stop, and traversing stairs. The maximum total individual score is 24 points (0-3 on each task), with higher scores indicating better function. A 4-point change in DGI would require an improvement of at least one level on four of 8 tasks, or multiple levels of improvement on several tasks. Thus, a 4-point change represents a clinically significant difference that is generally measurable without excessive variability.

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Registry information

Important dates

Study start: 2009
Primary completion: 2011
Study completion: 2011
First posted: Aug 4, 2020
Registry last updated: Aug 7, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed