Working…
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
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

Tracking Information
First Submitted Date  ICMJE May 16, 2014
First Posted Date  ICMJE June 2, 2014
Last Update Posted Date September 26, 2019
Study Start Date  ICMJE May 2014
Actual Primary Completion Date December 31, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 24, 2019)
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
Original Primary Outcome Measures  ICMJE
 (submitted: May 28, 2014)
Distance walked in 6 min [ Time Frame: The outcome will be measured immediately before and after 18 treatment sessions administered over a 6-week period (3 sessions/week). ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 3, 2014)
  • 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
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: May 28, 2014)
  • Maximal walking speed [ Time Frame: The outcome will be measured immediately before and after 18 treatment sessions administered over a 6-week period (3 sessions/week). ]
    The time it takes to walk 25 ft
  • Muscle strength [ Time Frame: The outcome will be measured immediately before and 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
  • Daily levels of physical activity [ Time Frame: The outcome will be measured immediately before and 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Neuromuscular Electrical Stimulation and Mobility in Multiple Sclerosis
Official Title  ICMJE Neuromuscular Electrical Stimulation and Mobility in Multiple Sclerosis
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Multiple Sclerosis
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • Experimental: Narrow pulse
    Six-week treatment of electrical stimulation applied to the calf muscles with stimulus pulses that last 0.4 ms.
    Intervention: Device: Narrow pulse
  • Experimental: Wide pulse
    Six-week treatment of electrical stimulation applied to the calf muscles with stimulus pulses that last 1 ms.
    Intervention: Device: Wide pulse
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 25, 2017)
25
Original Estimated Enrollment  ICMJE
 (submitted: May 28, 2014)
30
Actual Study Completion Date  ICMJE December 31, 2017
Actual Primary Completion Date December 31, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02152085
Other Study ID Numbers  ICMJE 13-0720
R03HD079508 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Roger Enoka, University of Colorado, Boulder
Study Sponsor  ICMJE University of Colorado, Boulder
Collaborators  ICMJE Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators  ICMJE
Principal Investigator: Roger Enoka, PhD University of Colorado, Boulder
Principal Investigator: Jeffrey Hebert, PhD, PT University of Colorado, Denver
PRS Account University of Colorado, Boulder
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP