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Neuromuscular Electrical Stimulation and Mobility in Multiple Sclerosis

Primary Purpose

Multiple Sclerosis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Narrow pulse
Wide pulse
Sponsored by
University of Colorado, Boulder
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring Walking, Mobility, Neuromuscular electrical stimulation, Multiple sclerosis

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Colorado

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Narrow pulse

Wide pulse

Arm Description

Six-week treatment of electrical stimulation applied to the calf muscles with stimulus pulses that last 0.4 ms.

Six-week treatment of electrical stimulation applied to the calf muscles with stimulus pulses that last 1 ms.

Outcomes

Primary Outcome Measures

Walking Endurance
Distance walked in 6 min
Modified Fatigue Impact Scale
MFIS scores range from 0 to 84 and higher numbers indicating worse fatigue.

Secondary Outcome Measures

Maximal Walking Speed
The time it takes to walk 25 ft

Full Information

First Posted
May 16, 2014
Last Updated
May 6, 2021
Sponsor
University of Colorado, Boulder
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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1. Study Identification

Unique Protocol Identification Number
NCT02152085
Brief Title
Neuromuscular Electrical Stimulation and Mobility in Multiple Sclerosis
Official Title
Neuromuscular Electrical Stimulation and Mobility in Multiple Sclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
May 2014 (undefined)
Primary Completion Date
December 31, 2017 (Actual)
Study Completion Date
December 31, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Colorado, Boulder
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
Walking, Mobility, Neuromuscular electrical stimulation, Multiple sclerosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Narrow pulse
Arm Type
Experimental
Arm Description
Six-week treatment of electrical stimulation applied to the calf muscles with stimulus pulses that last 0.4 ms.
Arm Title
Wide pulse
Arm Type
Experimental
Arm Description
Six-week treatment of electrical stimulation applied to the calf muscles with stimulus pulses that last 1 ms.
Intervention Type
Device
Intervention Name(s)
Narrow pulse
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Wide pulse
Intervention Description
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.
Primary Outcome Measure Information:
Title
Walking Endurance
Description
Distance walked in 6 min
Time Frame
Change from before to after 18 treatment sessions administered over a 6-week period (3 sessions/week).
Title
Modified Fatigue Impact Scale
Description
MFIS scores range from 0 to 84 and higher numbers indicating worse fatigue.
Time Frame
Change from before to after 18 treatment sessions administered over a 6-week period (3 sessions/week).
Secondary Outcome Measure Information:
Title
Maximal Walking Speed
Description
The time it takes to walk 25 ft
Time Frame
Change from before to after 18 treatment sessions administered over a 6-week period (3 sessions/week).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roger Enoka, PhD
Organizational Affiliation
University of Colorado, Boulder
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jeffrey Hebert, PhD, PT
Organizational Affiliation
University of Colorado, Denver
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Colorado
City
Boulder
State/Province
Colorado
ZIP/Postal Code
80309
Country
United States

12. IPD Sharing Statement

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Neuromuscular Electrical Stimulation and Mobility in Multiple Sclerosis

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