Functional Electrical Stimulation for Individuals With Secondary Progressive Multiple Sclerosis

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Evaluating the Effects of Functional Electrical Stimulation on Ambulation in Individuals With Secondary Progressive Multiple Sclerosis

Conditions
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Secondary Progressive Multiple Sclerosis

Intervention / Treatment
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* Behavioral: Active cycling
* Behavioral: Passive cycling


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 68 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active cycling<br>Individuals will receive functional electrical stimulation while on the stationary bike and instructed to actively pedal. | Behavioral: Active cycling<br>* 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.<br>* Other names: endurance training;|
| Sham Comparator: Passive cycling<br>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<br>* 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.<br>* Other names: letting the functional electrical stimulation move the legs;|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SPMS