Reducing Symptoms of Multiple Sclerosis Using Non-invasive Neuromodulation

NCT ID: NCT04498039

Last Updated: 2020-08-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-11-30
• Study Completion Date: 2011-05-31

Brief Summary

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.

Detailed Description

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).

Conditions

Multiple Sclerosis

Study Design

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

Study Groups

Active

Electrical stimulation to the tongue is delivered via the Portable Neuromodulation Stimulator (PoNS™) device . The PoNS™ device is held in place lightly by the lips and teeth around a rectangular tab that goes into the mouth and rests on the anterior, superior part of the tongue. Active subjects will be able to feel the sensation.

Group Type: EXPERIMENTAL

Portable Neuromodulation Stimulator

Intervention Type: 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.

Control

Electrical stimulation to the tongue will be delivered via the Portable Neuromodulation Stimulator (PoNS™) device . The PoNS™ device is held in place lightly by the lips and teeth around a rectangular tab that goes into the mouth and rests on the anterior, superior part of the tongue. Control subjects will be informed that while they may not feel the electrotactile stimulation, they are in-fact receiving a low level signal.

Group Type: SHAM_COMPARATOR

Portable Neuromodulation Stimulator

Intervention Type: 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.

Interventions

Portable Neuromodulation Stimulator

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.

Intervention Type: DEVICE

Other Intervention Names

PoNS

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Wisconsin, Madison

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mitchell E Tyler, P.E, M.S

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Other Identifiers

H2008-0252

Identifier Type: -

Identifier Source: org_study_id