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

  • United States
    • 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.
Device: Narrow pulse
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.
Device: Wide pulse
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

University of Colorado, Boulder

Collaborators

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

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

Keywords

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.

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