Multiple Sclerosis Clinical Trial
Epidural Stimulation in Multiple Sclerosis
Summary
A study to quantify changes in motor performance of epidural stimulation in progressive multiple sclerosis (MS) patients over the course of 12 rehabilitation sessions.
Full Description
The purpose of this trial is to study spinal motor nerve response to electrical stimulation delivered directly to the epidural space, and to measure any changes in motor performance during 12 sessions over the course of one month.
Eligibility Criteria
Inclusion Criteria:
Myelopathy secondary to Progressive MS
No clinical or radiologic MS relapses for > 5 years
EDSS score of 6.5 (constant bilateral assistance required to walk about 20 meters without resting) as assessed by a Neurologist with a specialty in MS
Able to ambulate 10 feet independently with or without gait aid use
At least 22 years of age
No changes to spasticity medications or dalfampridine over the last 3 months
Exclusion Criteria:
Currently a prison inmate, or awaiting trial, related to criminal activity
Pregnancy at the time of enrollment
History of chronic and/or treatment resistant urinary tract infection
Spasticity (grade of 4) measured bilaterally in two muscle groups using Modified Ashworth Scale (MAS). Muscle groups tested will include bilateral knee flexors, extensors; ankle plantarflexors, dorsiflexors
Unhealed decubitus ulcer
Unhealed skeletal fracture
Receiving diathermy treatment
Active participation in an interventional clinical trial
Any illness or condition which, based on the research team's assessment, will compromise the patient's ability to comply with the protocol, patient safety, or the validity of the data collected during this study.
History of coagulopathy or other significant cardiac or medical risk factors for surgery
Ventilator-dependent respiration
Diagnosed with cardiopulmonary dysfunction (e.g., chronic obstructive pulmonary disease, cardiac failure, or heart arrhythmia)
Untreated clinical diagnosis of depression
History of frequent hypotension characterized by light headedness, or loss of consciousness
History of frequent hypertension characterized by headache, or bradycardia
Any active, implanted medical device
Treatment of chemodenervation and/or neurolysis during the trial, or within 6 months of initiating the trial
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There is 1 Location for this study
Rochester Minnesota, 55905, United States More Info
Principal Investigator
Principal Investigator
Sub-Investigator
Sub-Investigator
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