Functional Electrical Stimulation for Individuals With Secondary Progressive Multiple Sclerosis
Status: | Recruiting |
---|---|
Conditions: | Neurology |
Therapuetic Areas: | Neurology |
Healthy: | No |
Age Range: | 18 - 68 |
Updated: | 9/30/2018 |
Start Date: | July 2012 |
End Date: | June 2020 |
Contact: | Sandi Cassard |
Email: | scassar1@jhmi.edu |
Phone: | 443-287-4353 |
Evaluating the Effects of Functional Electrical Stimulation on Ambulation in Individuals With Secondary Progressive Multiple Sclerosis
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.
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.
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.
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.
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
We found this trial at
1
site
601 North Caroline Street
Baltimore, Maryland 21205
Baltimore, Maryland 21205
Principal Investigator: S Newsome, MD
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