Status:
COMPLETED
Epidural Stimulation in Multiple Sclerosis
Lead Sponsor:
Kristin Zhao, PhD
Collaborating Sponsors:
Mayo Clinic
Conditions:
Multiple Sclerosis
Demyelinating Disorder
Eligibility:
All Genders
22+ years
Phase:
NA
Brief 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.
Detailed 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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 11 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 27 2024
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT06019611
Start Date
September 11 2023
End Date
February 27 2024
Last Update
April 27 2025
Active Locations (1)
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1
Mayo Clinic
Rochester, Minnesota, United States, 55905