Epidural Stimulation in Multiple Sclerosis

NCT06019611 | Completed Results DMC FDA Device

• 1 other identifier: 23-003967
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis; Demyelinating Disorder; Autoimmune Diseases

Outcome Measures

Primary Outcomes (5)

• Kinematics

  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.

  Baseline and 4 weeks.

• Static Balance, Eyes-open.

  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.

  Baseline and 4 weeks

• Electromyography (EMG)

  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.

  End of Study (4 weeks)

• Spasticity, Knee Extensors (1)

  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.

  End of Study (4 weeks)

• Spasticity, Knee Extensors (2)

  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+).

  End of Study (4 weeks)

Secondary Outcomes (10)

• 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

Study Arms (1)

Percutaneous Epidural Stimulation

EXPERIMENTAL

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.

Device: Percutaneous epidural stimulation

Interventions

Percutaneous epidural stimulation DEVICE

Abbott percutaneous trial lead for epidural neurostimulation (Model 3086) Abbott clinician programmer for epidural and dorsal root ganglion neurostimulation (Model 3874) Ripple Neuromed Nomad Neurostimulation System

Percutaneous Epidural Stimulation

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kristin Zhao, PhD: lead
• Mayo Clinic: collaborator

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis; Demyelinating Diseases; Autoimmune Diseases

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Immune System Diseases

Results Point of Contact

• Title: Dr. Kristin Zhao, Director of the Assistive and Restorative Technologies Laboratory
• Organization: Mayo Clinic

zhao.kristin@mayo.edu

507-284-8942

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 2, 2023
• First Posted: August 31, 2023
• Study Start: September 11, 2023
• Primary Completion: February 27, 2024
• Study Completion: February 27, 2024
• Last Updated: April 27, 2025
• Results First Posted: April 27, 2025

Record last verified: 2025-04

Locations

US (1)