Functional Electrical Stimulation for Individuals With Secondary Progressive Multiple Sclerosis

Sponsor
Johns Hopkins University (Other)
Overall Status
Completed
CT.gov ID
NCT01647321
Collaborator
Hugo W. Moser Research Institute at Kennedy Krieger, Inc. (Other)
16
1
2
87
0.2

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Active cycling
  • Behavioral: Passive cycling
N/A

Detailed Description

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 central nervous system (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.

Study Design

Study Type:
Interventional
Actual Enrollment :
16 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Evaluating the Effects of Functional Electrical Stimulation on Ambulation in Individuals With Secondary Progressive Multiple Sclerosis
Actual Study Start Date :
Jul 1, 2012
Actual Primary Completion Date :
Oct 1, 2019
Actual Study Completion Date :
Oct 1, 2019

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Active cycling

Individuals will receive functional electrical stimulation while on the stationary bike and instructed to actively pedal.

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
  • 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.

    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 Names:
  • letting the functional electrical stimulation move the legs
  • Outcome Measures

    Primary Outcome Measures

    1. Change in timed 25 foot walk from baseline to end of training [Participants are assessed at baseline (visit 1), one-month (visit 2), two-months (visit 3), three-months (visit 4), end of study (visit 5)]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 68 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Johns Hopkins / Kennedy Krieger Institute Baltimore Maryland United States 21205

    Sponsors and Collaborators

    • Johns Hopkins University
    • Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

    Investigators

    • Principal Investigator: Scott Newsome, MD, Johns Hopkins University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Johns Hopkins University
    ClinicalTrials.gov Identifier:
    NCT01647321
    Other Study ID Numbers:
    • NA_00069253
    First Posted:
    Jul 23, 2012
    Last Update Posted:
    Mar 19, 2020
    Last Verified:
    Mar 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Johns Hopkins University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 19, 2020