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Completed

NCT Number: NCT02152085

Neuromuscular Electrical Stimulation and Mobility in Multiple Sclerosis

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.

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Colorado

Boulder, Colorado, 80309, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Narrow pulse

Device

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.

Wide pulse

Device

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 outcomes

  1. 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

  2. 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.

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

University of Colorado, Boulder

Other

Collaborators

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

Registry information

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Jun 2, 2014
Registry last updated
May 7, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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