Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Neuromuscular Electrical Stimulation and Mobility in Multiple Sclerosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02152085
Recruitment Status : Completed
First Posted : June 2, 2014
Last Update Posted : September 26, 2019
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Roger Enoka, University of Colorado, Boulder

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.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Device: Narrow pulse Device: Wide pulse Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Neuromuscular Electrical Stimulation and Mobility in Multiple Sclerosis
Study Start Date : May 2014
Actual Primary Completion Date : December 31, 2017
Actual Study Completion Date : December 31, 2017

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  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


Secondary Outcome Measures :
  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

  2. Muscle strength [ Time Frame: Change from before to after 18 treatment sessions administered over a 6-week period (3 sessions/week). ]
    The peak force that can be produced by thigh (knee extensor) and calf (plantarflexor) muscles

  3. Daily levels of physical activity [ Time Frame: Change from before to after 18 treatment sessions administered over a 6-week period (3 sessions/week). ]
    Amount of physical activity as measured with accelerometers attached to the ankle



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02152085


Locations
Layout table for location information
United States, Colorado
University of Colorado
Boulder, Colorado, United States, 80309
Sponsors and Collaborators
University of Colorado, Boulder
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
Layout table for investigator information
Principal Investigator: Roger Enoka, PhD University of Colorado, Boulder
Principal Investigator: Jeffrey Hebert, PhD, PT University of Colorado, Denver
Layout table for additonal information
Responsible Party: Roger Enoka, Professor, University of Colorado, Boulder
ClinicalTrials.gov Identifier: NCT02152085    
Other Study ID Numbers: 13-0720
R03HD079508 ( U.S. NIH Grant/Contract )
First Posted: June 2, 2014    Key Record Dates
Last Update Posted: September 26, 2019
Last Verified: September 2019
Keywords provided by Roger Enoka, University of Colorado, Boulder:
Walking
Mobility
Neuromuscular electrical stimulation
Multiple sclerosis
Additional relevant MeSH terms:
Layout table for MeSH terms
Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases