Epidural Stimulation in Multiple Sclerosis

Kristin Zhao, PhD

Status: Completed

Conditions: Multiple Sclerosis; Demyelinating Disorder; Autoimmune Diseases

Treatments: Device: Percutaneous epidural stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT06019611

23-003967

Details and patient eligibility

About

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.

Enrollment: 2 patients

Sex: All

Ages: 22+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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2 participants in 1 patient group

Percutaneous Epidural Stimulation

Experimental group

Description:

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.

Treatment:

Device: Percutaneous epidural stimulation