Clinical trial NCT04498039: Reducing Symptoms of Multiple Sclerosis Using Non-invasive Neuromodulation
Official title: Reducing Symptoms of Multiple Sclerosis Using Non-invasive Neuromodulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2020-08-04
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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).
Primary purpose: DEVICE_FEASIBILITY

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).

Eligibility 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

Primary outcomes:
measure: Dynamic Gait Index DGI
timeFrame: 14 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Wisconsin, Madison
name: Mitchell E Tyler, P.E, M.S
role: PRINCIPAL_INVESTIGATOR
References: