View Clinical Trial (Medical Research Study)
Evaluating the Effects of Functional Electrical Stimulation on Ambulation in Individuals With Secondary Progressive Multiple Sclerosis
| City: |
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Baltimore |
| State: |
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Maryland |
| Zip Code: |
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21205 |
| Conditions: |
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Secondary Progressive Multiple Sclerosis |
| Purpose: |
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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.
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| Study Summary: |
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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 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.
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| 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
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| NCT ID: |
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NCT01647321 |
| Primary Contact: |
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Shannon Inches
Phone: 443-923-9235
Email: Inches@kennedykrieger.org
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| Backup Contact: |
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N/A |
| Location Contact: |
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Baltimore, Maryland 21205
United States
There is no listed contact information for this specific location.
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 20, 2013 |
| Modifications to this listing: |
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