A Pilot Study to Explore the Use of Percutaneous Spinal Stimulation in Participants With Multiple Sclerosis
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 2
- Locations
- 1
- Primary Endpoint
- Kinematics
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 22 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
Intervention: Percutaneous epidural stimulation (Device)
Outcomes
Primary Outcomes
Kinematics
Time Frame: Baseline and 4 weeks.
Change in maximum knee flexion, measured in degrees. Difference in maximum knee flexion between Baseline and End of Study with epidural stimulation off, and at End of Study between epidural stimulation off and epidural stimulation on.
Static Balance, Eyes-open.
Time Frame: Baseline and 4 weeks
Percentage of change in postural sway area (cm\^2) measured based on the center of force trajectory sway in the anterior-posterior and medial-lateral directions during static balance test with eyes-open. Decrease in postural sway area indicates an improvement in balance. Difference in postural sway area during balance test between Baseline and End of Study with epidural stimulation off, and at End of Study between epidural stimulation off and epidural stimulation on, both with subjects' eyes open, and closed.
Electromyography (EMG)
Time Frame: End of Study (4 weeks)
Percentage of change in Root Mean Square (RMS) (time averaging, period of 0.25 sec) electromyography (EMG) (normalized to the max value during all gait cycles) of hamstring and rectus femoris during late-stance to mid-swing phase of gait, at End of Study between epidural stimulation on and epidural stimulation off.
Spasticity, Knee Extensors (1)
Time Frame: End of Study (4 weeks)
Change in measurements of the first swing angle (FSA) leg muscle tone utilizing Wartenberg's pendulum test, focusing on subject's most impaired side, measured at End of Study between epidural stimulation off and epidural stimulation on.
Spasticity, Knee Extensors (2)
Time Frame: End of Study (4 weeks)
Change in measurement of leg muscle tone utilizing the Modified Ashworth Scale (MAS). The Modified Ashworth Scale (MAS) is the standard clinical assessment tool for evaluating extremity spasticity in patients with central nervous system lesions. In this study, spasticity in the knee extensor muscles was assessed with the participant in a supine position, their legs dangling off the edge of an adjustable-height therapy mat. The resistance to knee flexion was graded on a 0-4 scale (0, 1, 1+, 2, 3, and 4) according to the MAS protocol for knee flexion, with lower scores indicating less muscle tone (0: no increase in muscle tone; 4: limb rigid in flexion). MAS was scored individually for both the right and left sides and reported separately at the end of the study, both with and without epidural stimulation. (A score of 1.5 indicates a MAS score of 1+).
Secondary Outcomes
- Overground Ambulation(Baseline and 4 weeks)
- Disability(Baseline and 4 weeks)
- Fatigue(Baseline and 4 weeks)
- Pain, Overall(Baseline and 4 weeks)
- Bladder Control(Baseline and 4 weeks)
- Bowel Control(Baseline and 4 weeks)
- Impact of Visual Impairment(Baseline and 4 weeks)
- Cognitive Dysfunction(Baseline and 4 weeks)
- Mental Health(Baseline and 4 weeks)
- Social Support(Baseline and 4 weeks)
Investigators
Kristin Zhao, PhD
Principal Investigator
Mayo Clinic