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Clinical Trials/NCT02152085
NCT02152085
Completed
N/A

Neuromuscular Electrical Stimulation and Mobility in Multiple Sclerosis

University of Colorado, Boulder1 site in 1 country29 target enrollmentMay 2014

Overview

Phase
N/A
Intervention
Not specified
Conditions
Multiple Sclerosis
Sponsor
University of Colorado, Boulder
Enrollment
29
Locations
1
Primary Endpoint
Walking Endurance
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 2014
End Date
December 31, 2017
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Roger Enoka

Professor

University of Colorado, Boulder

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

Outcomes

Primary Outcomes

Walking Endurance

Time Frame: Change from before to after 18 treatment sessions administered over a 6-week period (3 sessions/week).

Distance walked in 6 min

Modified Fatigue Impact Scale

Time Frame: Change 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 Outcomes

  • Maximal Walking Speed(Change from before to after 18 treatment sessions administered over a 6-week period (3 sessions/week).)

Study Sites (1)

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