Neuromuscular Electrical Stimulation and Mobility in Multiple Sclerosis
May 6, 2021 updated by: Roger Enoka, University of Colorado, Boulder
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
29
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Colorado
-
Boulder, Colorado, United States, 80309
- University of Colorado
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Narrow pulse
Six-week treatment of electrical stimulation applied to the calf muscles with stimulus pulses that last 0.4 ms.
|
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.
|
|
Experimental: Wide pulse
Six-week treatment of electrical stimulation applied to the calf muscles with stimulus pulses that last 1 ms.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
Change from before to after 18 treatment sessions administered over a 6-week period (3 sessions/week).
|
|
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.
|
Change from before to after 18 treatment sessions administered over a 6-week period (3 sessions/week).
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Maximal Walking Speed
Time Frame: Change from before to after 18 treatment sessions administered over a 6-week period (3 sessions/week).
|
The time it takes to walk 25 ft
|
Change from before to after 18 treatment sessions administered over a 6-week period (3 sessions/week).
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Roger Enoka, PhD, University of Colorado, Boulder
- Principal Investigator: Jeffrey Hebert, PhD, PT, University of Colorado, Denver
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2014
Primary Completion (Actual)
December 31, 2017
Study Completion (Actual)
December 31, 2017
Study Registration Dates
First Submitted
May 16, 2014
First Submitted That Met QC Criteria
May 28, 2014
First Posted (Estimate)
June 2, 2014
Study Record Updates
Last Update Posted (Actual)
May 7, 2021
Last Update Submitted That Met QC Criteria
May 6, 2021
Last Verified
May 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 13-0720
- R03HD079508 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.