Reducing Symptoms of Multiple Sclerosis Using Non-invasive Neuromodulation

Multiple Sclerosis Clinical Trial

Official title:

Reducing Symptoms of Multiple Sclerosis Using Non-invasive Neuromodulation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04498039
• Other study ID #: H2008-0252
• Status: Completed
• Phase: N/A
• Start date: November 2009
• Est. completion date: May 2011

Study information

• Verified date: August 2020
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Device:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Wisconsin, Madison

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dynamic Gait Index DGI	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.	14 weeks