Functional Electrical Stimulation for Individuals With Secondary Progressive Multiple Sclerosis

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2016 by Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Sponsor:
Information provided by (Responsible Party):
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
ClinicalTrials.gov Identifier:
NCT01647321
First received: July 19, 2012
Last updated: February 22, 2016
Last verified: February 2016

July 19, 2012
February 22, 2016
July 2012
January 2017   (final data collection date for primary outcome measure)
Change in timed 25 foot walk from baseline to end of training [ Time Frame: Participants are assessed at baseline (visit 1), one-month (visit 2), two-months (visit 3), three-months (visit 4), end of study (visit 5) ] [ Designated as safety issue: No ]
Here we will assess whether a subjects walking speed is improved following active cycling with functional electrical stimulation. Our prediction is that individuals will improve in their walking function following seated active cycling with functional electrical stimulation.
Same as current
Complete list of historical versions of study NCT01647321 on ClinicalTrials.gov Archive Site
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Functional Electrical Stimulation for Individuals With Secondary Progressive Multiple Sclerosis
Evaluating the Effects of Functional Electrical Stimulation on Ambulation in Individuals With Secondary Progressive Multiple Sclerosis
Secondary progressive multiple sclerosis (SPMS) is a subtype of multiple sclerosis (MS) for which there are no existing therapies that alter the disease course. This research will utilize cutting edge functional electrical stimulation (FES) cycling technology with the goal of improving walking in individuals with SPMS. The investigators hypothesize that FES cycling will improve walking in subjects with SPMS.
Individuals with secondary progressive multiple sclerosis (SPMS) experience significant impairments in ambulation leading to use of canes, walkers, and ultimately wheelchairs. Treatment attempts for progressive MS have been disappointing. No therapeutic intervention has been shown to modulate disability in patients with SPMS. FES cycling has been shown to have multiple primary medical benefits including: increased muscle mass, improvements in bone density, enhanced cardiovascular function, improved bowel function, decreased spasticity and reductions in bladder infection rate. More importantly FES may modulate the inflammatory CNS environment in progressive MS. The investigators are proposing a novel, and easy to implement intervention strategy of FES cycling to help improve gait function in individuals with SPMS. A successful outcome on a larger SPMS population would have significant impact towards changing MS clinical care. FES is easily transferable to clinical practice and could potentially ameliorate other complications associated with SPMS such as spasticity, mood and fatigue reducing the burden of health care cost. In addition, the investigators will gain a better understanding of the mechanisms underlying these changes that could be used to design new therapeutic strategies.
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Secondary Progressive Multiple Sclerosis
  • Behavioral: Active cycling
    The exercise program uses a stationary bike equipped with functional electrical stimulation (FES) of leg muscles. Participants are instructed to actively pedal while the FES is assisting. The training program is expected to be performed for one hour, three times a week for 12 weeks.
    Other Names:
    • cycling
    • endurance training
  • Behavioral: Passive cycling
    The exercise program uses a stationary bike equipped with functional electrical stimulation (FES) of leg muscles. Participants are instructed to sit passively on the stationary bile while the FES is assisting. The training program is expected to be performed for one hour, three times a week for 12 weeks.
    Other Name: letting the functional electrical stimulation move the legs
  • Active Comparator: Active cycling
    Individuals will receive functional electrical stimulation while on the stationary bike and instructed to actively pedal.
    Intervention: Behavioral: Active cycling
  • Sham Comparator: Passive cycling
    Individuals will receive active functional electrical stimulation (FES) while on the stationary bike and instructed to relax their legs, allowing the FES to move their legs on the stationary bike.
    Intervention: Behavioral: Passive cycling
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
20
January 2017
January 2017   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • clinical diagnosis of secondary progressive multiple sclerosis
  • males and females between the ages of 18 and 65 years
  • Expanded disability status scale score between 5.0 and 7.0
  • Able to consent to participate in study and are willing to undergo a lumbar puncture and blood draws
  • If on on Ampyra or anti-spasticity agent, must be on stable dose for 1 month prior to screening
  • No functional electrical stimulation use within 4 weeks
  • Participants must be medically stable with no recent (1 month or less) inpatient admission for acute medical or surgical issues

Exclusion Criteria:

  • Uncontrolled hypertension or other significant cardiovascular disease as determined by investigator
  • History of epileptic seizures
  • Subjects who have a pacemaker
  • Relapse within thirty days prior to screening visit
  • Pregnancy
  • Subjects having a Stage 2 or greater sacral decubitus ulcer
Both
18 Years to 65 Years   (Adult)
No
Contact: Shannon Inches 443-923-9235 Inches@kennedykrieger.org
United States
 
NCT01647321
NA_00069253
No
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Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Not Provided
Not Provided
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
February 2016

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