Neuromuscular Electrical Stimulation and Mobility in Multiple Sclerosis

University of Colorado Boulder (CU)

Status: Completed

Conditions: Multiple Sclerosis

Treatments: Device: Wide pulse; Device: Narrow pulse

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02152085

R03HD079508 (U.S. NIH Grant/Contract)

13-0720

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 29 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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29 participants in 2 patient groups

Narrow pulse

Experimental group

Description:

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

Treatment:

Device: Narrow pulse

Wide pulse

Experimental group

Description:

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

Treatment:

Device: Wide pulse