Neuromuscular Electrical Stimulation and Mobility in Multiple Sclerosis

CompletedNot a drug-phase studyMS (type not specified)NCT02152085

What it found

Results posted, not judged

Results are posted in the registry, but without a statistical test of the main measure. See the numbers below.

What was tested

Treatment tested

  • Narrow pulse
  • Wide pulse

Results by group

Walking Endurance

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

GroupValueIntervalNumber analysed
Narrow Pulse42 meters60 (Standard Deviation)14
Wide Pulse25 meters35 (Standard Deviation)13

Narrow Pulse

42

Wide Pulse

25

Modified Fatigue Impact Scale

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

GroupValueIntervalNumber analysed
Narrow Pulse34 score on a scale17 (Standard Deviation)14
Wide Pulse23 score on a scale14 (Standard Deviation)13

Narrow Pulse

34

Wide Pulse

23

Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.

Safety

GroupParticipants at riskSerious adverse eventsDeaths
Narrow Pulse130 (0.0%)0
Wide Pulse140 (0.0%)0

As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.

What it measured

Main measures

  • Walking Endurance

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

    Walking and mobility
  • Modified Fatigue Impact Scale

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

    Fatigue

Other measures (1)

  • Maximal Walking Speed

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

    Walking and mobility

Who could take part

MS (type not specified) · 18 to 55

Show the full 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

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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.

Papers

Loading reviews and guidelines…

History

    1. Started

      May 2014

    2. Main results due

      Dec 2017

    3. Finished

      Dec 2017

    4. Results posted

      May 2021

    Assembled by software from public sources.