Clinical trial NCT02152085: Neuromuscular Electrical Stimulation and Mobility in Multiple Sclerosis
Official title: Neuromuscular Electrical Stimulation and Mobility in Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Keywords: Walking
Mobility
Neuromuscular electrical stimulation
Multiple sclerosis
Lead sponsor: University of Colorado, Boulder
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2014-06-02
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Walking Endurance
timeFrame: Change from before to after 18 treatment sessions administered over a 6-week period (3 sessions/week).
measure: Modified Fatigue Impact Scale
timeFrame: Change from before to after 18 treatment sessions administered over a 6-week period (3 sessions/week).
Secondary outcomes:
measure: Maximal Walking Speed
timeFrame: Change from before to after 18 treatment sessions administered over a 6-week period (3 sessions/week).
Other outcomes:
Locations:
city: Boulder
country: United States
facility: University of Colorado
state: Colorado
Study officials:
affiliation: University of Colorado, Boulder
name: Roger Enoka, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Colorado, Denver
name: Jeffrey Hebert, PhD, PT
role: PRINCIPAL_INVESTIGATOR
References: