Neuromuscular Electrical Stimulation and Mobility in Multiple Sclerosis

Study Overview
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Brief Summary
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The purpose of this study is to investigate the capacity of a 6-week treatment with neuromuscular electrical stimulation to improve walking in individuals whose mobility has been compromised by multiple sclerosis.

Detailed Description
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Participants will be randomly assigned to one of two study arms. Those in one arm will receive a treatment with narrow stimulus pulses (0.4 ms) and those in the other arm will receive wide stimulus pulses (1 ms). The electrical stimulation will be delivered with a Vectra Genisys System.

Official Title
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Neuromuscular Electrical Stimulation and Mobility in Multiple Sclerosis

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Device: Narrow pulse
* Device: Wide pulse


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Able to read, understand, and speak English to ensure safe participation in the project Difficulties with walking On stable doses of Ampyra, provigil, or other symptomatic-treating medications No systemic steroids within the last 30 days Not currently exercising more than 2x/wk Able to arrange own transportation to and from the laboratories Provide informed consent, including willingness to be randomly assigned to one of the two groups Exclusion Criteria: Documented MS-related relapse in the last 3 months Medical diagnosis or condition that is considered to be an absolute or relative contraindication to participating in exercise training, such as major renal, pulmonary, hepatic, cardiac, gastrointestinal, HIV, cancer (other than treated basal cell cancer), other neurological disorders, or pregnancy Poorly controlled diabetes mellitus or hypertension History of seizure disorders Alcohol dependence or abuse (≥2 drinks/day), or present history (last 6 months) of drug abuse Inability to attend exercise sessions 3 days per week for 6 weeks

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Narrow pulse<br>Six-week treatment of electrical stimulation applied to the calf muscles with stimulus pulses that last 0.4 ms. | Device: Narrow pulse<br>* Participants will be randomly assigned to one of two study arms to receive a 6 week treatment of electrical stimulation that comprises narrow (0.4 ms) stimulus pulses.<br>|
| Experimental: Wide pulse<br>Six-week treatment of electrical stimulation applied to the calf muscles with stimulus pulses that last 1 ms. | Device: Wide pulse<br>* Participants will be randomly assigned to one of two study arms to receive a 6 week treatment of electrical stimulation that comprises wide (1 ms) stimulus pulses.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Walking Endurance | Distance walked in 6 min | Change from before to after 18 treatment sessions administered over a 6-week period (3 sessions/week). | 
| Modified Fatigue Impact Scale | MFIS scores range from 0 to 84 and higher numbers indicating worse fatigue. | Change from before to after 18 treatment sessions administered over a 6-week period (3 sessions/week). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximal Walking Speed | The time it takes to walk 25 ft | Change from before to after 18 treatment sessions administered over a 6-week period (3 sessions/week). | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Walking, Mobility, Neuromuscular electrical stimulation, Multiple sclerosis