Clinical trial NCT06019611: Epidural Stimulation in Multiple Sclerosis
Official title: A Pilot Study to Explore the Use of Percutaneous Spinal Stimulation in Participants With Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Demyelinating Disorder
Autoimmune Diseases
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: Mayo Clinic
First posted: 2023-08-31
Enrollment: 2
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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 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

Primary outcomes:
measure: Kinematics
timeFrame: Baseline and 4 weeks.
measure: Static Balance, Eyes-open.
timeFrame: Baseline and 4 weeks
measure: Electromyography (EMG)
timeFrame: End of Study (4 weeks)
measure: Spasticity, Knee Extensors (1)
timeFrame: End of Study (4 weeks)
measure: Spasticity, Knee Extensors (2)
timeFrame: End of Study (4 weeks)
Secondary outcomes:
measure: Overground Ambulation
timeFrame: Baseline and 4 weeks
measure: Disability
timeFrame: Baseline and 4 weeks
measure: Fatigue
timeFrame: Baseline and 4 weeks
measure: Pain, Overall
timeFrame: Baseline and 4 weeks
measure: Bladder Control
timeFrame: Baseline and 4 weeks
measure: Bowel Control
timeFrame: Baseline and 4 weeks
measure: Impact of Visual Impairment
timeFrame: Baseline and 4 weeks
measure: Cognitive Dysfunction
timeFrame: Baseline and 4 weeks
measure: Mental Health
timeFrame: Baseline and 4 weeks
measure: Social Support
timeFrame: Baseline and 4 weeks
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
References: