Functional Electrical Stimulation for Individuals With Secondary Progr
Evaluating the Effects of Functional Electrical Stimulation on Ambulation in Individuals With Secondary Progressive Multiple Sclerosis
What it found
We found no results in the registry or in papers.
This trial finished 7 years ago. We found no results in the registry or in any paper that cites it.
What was tested
Treatment tested
- Active cycling
Placebo
- Passive cycling
What it measured
Main measures
Change in timed 25 foot walk from baseline to end of training
Participants are assessed at baseline (visit 1), one-month (visit 2), two-months (visit 3), three-months (visit 4), end of study (visit 5)
Disability progressionWalking and mobility
Who could take part
Progressive MS · 18 to 68
Show the full 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
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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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History
Started
Jul 2012
Main results due
Oct 2019
Finished
Oct 2019