Reducing Symptoms of Multiple Sclerosis Using Non-invasive Neuromodulation

University of Wisconsin (UW)

Status: Completed

Conditions: Multiple Sclerosis

Treatments: Device: Portable Neuromodulation Stimulator

Study type: Interventional

Funder types: Other

Identifiers

NCT04498039

H2008-0252

Details and patient eligibility

About

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.

Full 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).

Enrollment: 20 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Device Feasibility

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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20 participants in 2 patient groups

Active

Experimental group

Description:

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.

Treatment:

Device: Portable Neuromodulation Stimulator

Control

Sham Comparator group

Description:

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.

Treatment:

Device: Portable Neuromodulation Stimulator