Neuromuscular Electrical Stimulation and Mobility in Multiple Sclerosis

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2017-12-31

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.

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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.

Conditions

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Multiple Sclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Narrow pulse

Six-week treatment of electrical stimulation applied to the calf muscles with stimulus pulses that last 0.4 ms.

Group Type EXPERIMENTAL

Narrow pulse

Intervention Type DEVICE

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.

Wide pulse

Six-week treatment of electrical stimulation applied to the calf muscles with stimulus pulses that last 1 ms.

Group Type EXPERIMENTAL

Wide pulse

Intervention Type DEVICE

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.

Interventions

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Narrow pulse

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.

Intervention Type DEVICE

Wide pulse

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.

Intervention Type DEVICE

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No