NCT02152085

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at P25-P50 for not_applicable multiple-sclerosis

Timeline
Completed

Started May 2014

Longer than P75 for not_applicable multiple-sclerosis

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2014

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

May 16, 2014

Completed
17 days until next milestone

First Posted

Study publicly available on registry

June 2, 2014

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2017

Completed
3.4 years until next milestone

Results Posted

Study results publicly available

May 7, 2021

Completed
Last Updated

May 7, 2021

Status Verified

May 1, 2021

Enrollment Period

3.7 years

First QC Date

May 16, 2014

Results QC Date

November 19, 2020

Last Update Submit

May 6, 2021

Conditions

Multiple Sclerosis

Keywords

WalkingMobilityNeuromuscular electrical stimulationMultiple sclerosis

Outcome Measures

Primary Outcomes (2)

  • Walking Endurance

    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

    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 Outcomes (1)

  • Maximal Walking Speed

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

Study Arms (2)

Narrow pulse

EXPERIMENTAL

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

Device: Narrow pulse

Wide pulse

EXPERIMENTAL

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

Device: Wide pulse

Interventions

Narrow pulseDEVICE

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.

Narrow pulse
Wide pulseDEVICE

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.

Wide pulse

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Colorado

Boulder, Colorado, 80309, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Results Point of Contact

Title
Roger Enoka
Organization
University of Colorado Boulder
enoka@colorado.edu
3034927232

Study Officials

  • Roger Enoka, PhD

    University of Colorado, Boulder

    PRINCIPAL INVESTIGATOR

  • Jeffrey Hebert, PhD, PT

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 16, 2014

First Posted

June 2, 2014

Study Start

May 1, 2014

Primary Completion

December 31, 2017

Study Completion

December 31, 2017

Last Updated

May 7, 2021

Results First Posted

May 7, 2021

Record last verified: 2021-05

Locations

US(1)