Epidural Stimulation in Multiple Sclerosis

A Pilot Study to Explore the Use of Percutaneous Spinal Stimulation in Participants With Multiple Sclerosis

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06019611

Enrollment

Registered

2023-08-31

Start date

2023-09-11

Completion date

2024-02-27

Last updated

2025-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autoimmune Diseases, Demyelinating Disorder, Multiple Sclerosis

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.

Interventions

DEVICEPercutaneous epidural stimulation

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

22 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Kinematics	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.	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)	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)	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)	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

Measure	Time frame	Description
Bowel Control	Baseline and 4 weeks	Measurement of changes in patient-reported bladder control, utilizing the Bowel Control Scale (BWCS). Items are scaled so that lower scores indicate a greater degree of bowel control. The total BWCS score can range from 0 to 26, with a score of 0 equivalent to complete bowel control and a score of 26 equivalent to very poor bowel control.
Impact of Visual Impairment	Baseline and 4 weeks	Measurement of changes in patient-reported visual impairment, utilizing the Impact of Visual Impairment Scale (IVIS). Items are scaled so that lower scores indicate less impairment on simple visual tasks. The total IVIS score can range from 0 to 15, with a score of 0 equivalent to no impairment and a score of 15 equivalent to severe visual impairment.
Overground Ambulation	Baseline and 4 weeks	Change in walking speed during gait analysis, measured between Baseline and End of Study with epidural stimulation off, and at End of Study between epidural stimulation off and epidural stimulation on.
Mental Health	Baseline and 4 weeks	Measurement of changes in patient-reported psychological distress and psychological well-being, utilizing the Mental Health Inventory (MHI-18). Items are scaled so that higher scores indicate less psychological distress. The raw score range is 0-100, with higher scores equivalent to less psychological distress and greater psychological well-being.
Social Support	Baseline and 4 weeks	Measurement of changes in patient-reported availability of social support, utilizing the Modified Social Support Survey (MSSS). Items are scaled so that higher scores indicate more social support. The total MSSS score can range from 18 to 90, with a score of 18 equivalent to no social support and a score of 90 equivalent to strong social support.
Cognitive Dysfunction	Baseline and 4 weeks	Measurement of changes in patient-reported cognitive dysfunction, utilizing the Perceived Deficits Questionnaire (PDQ). Items are scaled so that lower scores indicate less cognitive dysfunction. The total PDQ score can range from 0 to 80, with a score of 0 equivalent to no cognitive dysfunction and a score of 80 equivalent to extreme cognitive dysfunction.
Disability	Baseline and 4 weeks	Measurement of changes in patient-reported disability status, utilizing the Short Form (36) Health Survey (SF-36). Questions are numerically ranked, with lower numbers representing more disability. Scores are combined into a composite scale from 0-100, with a score of zero equivalent to maximum disability and a score of 100 equivalent to no disability.
Fatigue	Baseline and 4 weeks	Measurement of changes in patient-reported fatigue status, utilizing the Modified Fatigue Impact Scale (MFIS). Items are scaled so that higher scores indicate a greater impact of fatigue on a person's activities. The total MFIS score can range from 0 to 84, with a score of zero equivalent to no fatigue and a score of 84 equivalent to maximum fatigue.
Pain, Overall	Baseline and 4 weeks	Measurement of changes in patient-reported pain status, utilizing the Pain Effects Scale (PES). Items are scaled so that higher scores indicate a greater impact of pain on a person's activities. The total PES score can range from 5 to 30, with a score of 5 equivalent to no pain and a score of 30 equivalent to maximum pain.
Bladder Control	Baseline and 4 weeks	Measurement of changes in patient-reported bladder control, utilizing the Bladder Control Scale (BLCS). Items are scaled so that lower scores indicate a greater degree of bladder control. The total BLCS score can range from 0 to 22, with a score of 0 equivalent to complete bladder control and a score of 22 equivalent to very poor bladder control.

Countries

United States

Participant flow

Recruitment details

Of 2 enrolled participants, 2 met inclusion criteria and proceeded to treatment.

Participants by arm

Arm	Count
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. Percutaneous epidural stimulation: 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	2
Total	2

Arm

Count

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. Percutaneous epidural stimulation: 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

Total

Baseline characteristics

Characteristic	Percutaneous Epidural Stimulation
Age, Customized Age 21 - 40	0 Participants
Age, Customized Age 41+	2 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants
Race (NIH/OMB) Asian	0 Participants
Race (NIH/OMB) Black or African American	0 Participants
Race (NIH/OMB) More than one race	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants
Race (NIH/OMB) White	2 Participants
Sex: Female, Male Female	0 Participants
Sex: Female, Male Male	2 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	0 / 2
other Total, other adverse events	2 / 2
serious Total, serious adverse events	0 / 2

Outcome results

Primary

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.

Time frame: End of Study (4 weeks)

Arm	Measure	Group	Value (MEAN)
Percutaneous Epidural Stimulation	Electromyography (EMG)	Change in voltage measurements of rectus femoris at End of Study, between ES on and ES off	-7 percent change
Percutaneous Epidural Stimulation	Electromyography (EMG)	Change in voltage measurements of hamstring at End of Study, between ES on and ES off	20 percent change

Primary

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.

Time frame: Baseline and 4 weeks.

Arm	Measure	Group	Value (MEAN)
Percutaneous Epidural Stimulation	Kinematics	Difference in maximum knee flexion between Baseline and End of Study with ES off	15.5 degrees
Percutaneous Epidural Stimulation	Kinematics	Difference in maximum knee flexion at End of Study between ES off and ES on	10 degrees

Primary

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.

Time frame: End of Study (4 weeks)

Arm	Measure	Value (MEAN)
Percutaneous Epidural Stimulation	Spasticity, Knee Extensors (1)	6.5 degrees

Primary

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+).

Time frame: End of Study (4 weeks)

Population: 1 participant analyzed per row.

Arm	Measure	Group	Value (NUMBER)
Percutaneous Epidural Stimulation	Spasticity, Knee Extensors (2)	Participant 1, right side, ES off	2 score on a scale
Percutaneous Epidural Stimulation	Spasticity, Knee Extensors (2)	Participant 1, right side, ES on	1.5 score on a scale
Percutaneous Epidural Stimulation	Spasticity, Knee Extensors (2)	Participant 1, left side, ES off	2 score on a scale
Percutaneous Epidural Stimulation	Spasticity, Knee Extensors (2)	Participant 1, left side, ES on	0 score on a scale
Percutaneous Epidural Stimulation	Spasticity, Knee Extensors (2)	Participant 2, right side, ES off	1.5 score on a scale
Percutaneous Epidural Stimulation	Spasticity, Knee Extensors (2)	Participant 2, right side, ES on	1.5 score on a scale
Percutaneous Epidural Stimulation	Spasticity, Knee Extensors (2)	Participant 2, left side, ES off	1.5 score on a scale
Percutaneous Epidural Stimulation	Spasticity, Knee Extensors (2)	Participant 2, left side, ES on	1 score on a scale

Primary

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.