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Functional Electrical Stimulation for Individuals With Secondary Progressive Multiple Sclerosis

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ClinicalTrials.gov Identifier: NCT01647321
Recruitment Status : Recruiting
First Posted : July 23, 2012
Last Update Posted : August 30, 2017
Sponsor:
Collaborator:
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Information provided by (Responsible Party):
Johns Hopkins University

Study Description
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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
Secondary Progressive Multiple Sclerosis Behavioral: Active cycling Behavioral: Passive cycling Phase 1

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 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 : July 2012
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2020

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U.S. FDA Resources

Arms and Interventions
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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 Name: letting the functional electrical stimulation move the legs


Outcome Measures
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Primary Outcome Measures :
  1. 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) ]
    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
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Ages Eligible for Study:   18 Years to 68 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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): NCT01647321


Contacts
Contact: Sandi Cassard 443-287-4353 scassar1@jhmi.edu

Locations
United States, Maryland
Johns Hopkins / Kennedy Krieger Institute Recruiting
Baltimore, Maryland, United States, 21205
Principal Investigator: S Newsome, MD         
Sponsors and Collaborators
Johns Hopkins University
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01647321     History of Changes
Other Study ID Numbers: NA_00069253
First Posted: July 23, 2012    Key Record Dates
Last Update Posted: August 30, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Johns Hopkins University:
SPMS

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Neoplasm Metastasis
Multiple Sclerosis, Chronic Progressive
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
 Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Neoplastic Processes
Neoplasms