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Neuromuscular Electrical Stimulation and Mobility in Multiple Sclerosis

Not Applicable
Completed
Conditions
Multiple Sclerosis
Interventions
Device: Wide pulse
Device: Narrow pulse
Registration Number
NCT02152085
Lead Sponsor
University of Colorado, Boulder
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
29
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Wide pulseWide pulseSix-week treatment of electrical stimulation applied to the calf muscles with stimulus pulses that last 1 ms.
Narrow pulseNarrow pulseSix-week treatment of electrical stimulation applied to the calf muscles with stimulus pulses that last 0.4 ms.
Primary Outcome Measures
NameTimeMethod
Walking EnduranceChange from before to after 18 treatment sessions administered over a 6-week period (3 sessions/week).

Distance walked in 6 min

Modified Fatigue Impact ScaleChange from before to after 18 treatment sessions administered over a 6-week period (3 sessions/week).

MFIS scores range from 0 to 84 and higher numbers indicating worse fatigue.

Secondary Outcome Measures
NameTimeMethod
Maximal Walking SpeedChange from before to after 18 treatment sessions administered over a 6-week period (3 sessions/week).

The time it takes to walk 25 ft

Trial Locations

Locations (1)

University of Colorado

🇺🇸

Boulder, Colorado, United States

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