Functional Electrical Stimulation for Individuals With Secondary Progressive Multiple Sclerosis
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Secondary Progressive Multiple Sclerosis |
Behavioral: exercise training |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Evaluating the Effects of Functional Electrical Stimulation on Ambulation in Individuals With Secondary Progressive Multiple Sclerosis |
- 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.
| Estimated Enrollment: | 20 |
| Study Start Date: | July 2012 |
| Estimated Study Completion Date: | October 2014 |
| Estimated Primary Completion Date: | June 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: functional electrical stimulation
Individuals will receive active functional electrical stimulation while on the stationary bike, or their legs will be passively moved while on the stationary bike during the exercise sessions.
|
Behavioral: exercise training
The exercise program uses a stationary bike equipped with functional electrical stimulation of leg muscles. The training program is expected to be performed for one hour, three times a week for 12 weeks.
Other Names:
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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 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.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| 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 LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT01647321
| Contact: Shannon Inches | 443-923-9235 | Inches@kennedykrieger.org |
| United States, Maryland | |
| Kennedy Krieger Institute / Johns Hopkins | Recruiting |
| Baltimore, Maryland, United States, 21205 | |
| Principal Investigator: K M Zackowski, PhD | |
More Information
No publications provided
| Responsible Party: | Hugo W. Moser Research Institute at Kennedy Krieger, Inc. |
| ClinicalTrials.gov Identifier: | NCT01647321 History of Changes |
| Other Study ID Numbers: | NA_00069253 |
| Study First Received: | July 19, 2012 |
| Last Updated: | September 25, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Hugo W. Moser Research Institute at Kennedy Krieger, Inc.:
|
SPMS |
Additional relevant MeSH terms:
|
Multiple Sclerosis Multiple Sclerosis, Chronic Progressive Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System |
Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases Pathologic Processes |
ClinicalTrials.gov processed this record on March 03, 2015