Epidural Stimulation in Multiple Sclerosis
Multiple Sclerosis, Demyelinating Disorder, Autoimmune Diseases
About this trial
This is an interventional basic science trial for Multiple Sclerosis
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
Sites / Locations
- Mayo ClinicRecruiting
Arms of the Study
Arm 1
Experimental
Percutaneous Epidural Stimulation
Epidural spinal stimulation will be delivered via percutaneously implanted electrodes during rehabilitation. All implanted electrodes will be removed at the end of trial participation. The effects of epidural stimulation will be recorded via electrophysiological and biomechanical metrics described within the outcomes measures.