Multiple SclerosisNCT06019611

Epidural Stimulation in Multiple Sclerosis

A study testing Percutaneous epidural stimulation in people with Multiple Sclerosis and Demyelinating Disorder, run by Kristin Zhao, PhD at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 22 years and older
Conditions the study is for: Multiple Sclerosis, Demyelinating Disorder, Autoimmune Diseases
What is being tested?: Percutaneous epidural stimulation
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 2 participants
Where: 1 siteUnited States
Study dates: 11 Sep 2023to 27 Feb 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 22 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 17Show fewer

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 locations and contacts

1 site in 1 country.

United States1 site

Mayo Clinic
Rochester, Minnesota, 55905

Other trials in United States

About this study

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

A study to quantify changes in motor performance of epidural stimulation in progressive multiple sclerosis (MS) patients over the course of 12 rehabilitation sessions.

Read the 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.

Conditions: Multiple Sclerosis, Demyelinating Disorder, Autoimmune Diseases
Being tested: Percutaneous epidural stimulation
Medical subject headings: Multiple Sclerosis, Demyelinating Diseases, Autoimmune Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Percutaneous epidural stimulationDevice
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 groups in NCT06019611
Study group	Role	What they receive
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. Receives: Device: Percutaneous epidural stimulation

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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+).
Measured: End of Study (4 weeks)

Secondary outcomes (10)

Overground Ambulation
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.
Measured: Baseline and 4 weeks
Disability
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.
Measured: Baseline and 4 weeks
Fatigue
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.
Measured: Baseline and 4 weeks
Pain, Overall
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.
Measured: Baseline and 4 weeks
Bladder Control
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.
Measured: Baseline and 4 weeks
Bowel Control
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.
Measured: Baseline and 4 weeks
Impact of Visual Impairment
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.
Measured: Baseline and 4 weeks
Cognitive Dysfunction
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.
Measured: Baseline and 4 weeks
Mental Health
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.
Measured: Baseline and 4 weeks
Social Support
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.
Measured: Baseline and 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

11 Sep 202327 Feb 2024

First posted31 Aug 2023
Study start11 Sep 2023
Primary completion27 Feb 2024
Study completion27 Feb 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Multiple SclerosisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Basic science
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 2 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06019611
Sponsor's protocol ID: 23-003967
Status last verified: Apr 2025
First submitted: 2 Aug 2023
Last updated: 27 Apr 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes

Publications

Jahanian O, Asp AJ, Gill ML, Veith DD, Fernandez KA, Hogen CA, Mills CJ, Thoreson AR, Solinsky R, Kaufman KR, Grahn PJ, Zhao KD, Tobin WO. Percutaneous spinal stimulation to enhance gait and alleviate functional impairments in multiple sclerosis: A pilot study. Mult Scler J Exp Transl Clin. 2026 Apr 29;12(2):20552173261432301. doi: 10.1177/20552173261432301. eCollection 2026 Apr-Jun.
PubMed 42112095

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 27 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Pilot Study to Explore the Use of Percutaneous Spinal Stimulation in Participants With Multiple Sclerosis
ClinicalTrials.gov ID: NCT06019611
Acronym / sponsor ID: 23-003967
Conditions: Multiple Sclerosis, Demyelinating Disorder, Autoimmune Diseases
Study type: Interventional
Recruitment status: Completed
Enrolment: 2 participants (actual)
Lead sponsor: Kristin Zhao, PhDUniversity, hospital or other
Collaborators: Mayo Clinic
Study start: 11 Sep 2023 (actual)
Primary completion: 27 Feb 2024 (actual)
Study completion: 27 Feb 2024 (actual)
First posted: 31 Aug 2023 (actual)
Results: Posted 27 Apr 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Basic science
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Percutaneous Epidural Stimulation	Experimental	Device: Percutaneous epidural stimulationEpidural 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.

Who may qualify

Ages: 22 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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

Key exclusion criteria (17 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Percutaneous epidural stimulationAbbott 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	Device	Percutaneous Epidural Stimulation

Primary outcome

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+).

10 secondary outcomes

Overground Ambulation
Time frame: Baseline and 4 weeks
Disability
Time frame: Baseline and 4 weeks
Fatigue
Time frame: Baseline and 4 weeks
Pain, Overall
Time frame: Baseline and 4 weeks
Bladder Control
Time frame: Baseline and 4 weeks
Bowel Control
Time frame: Baseline and 4 weeks
Impact of Visual Impairment
Time frame: Baseline and 4 weeks
Cognitive Dysfunction
Time frame: Baseline and 4 weeks
Mental Health
Time frame: Baseline and 4 weeks
Social Support
Time frame: Baseline and 4 weeks

Results and safety

Results posted to the registry on 27 Apr 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Percutaneous Epidural Stimulation	2	2

Primary outcome: Kinematics

Time frame: Baseline and 4 weeks.. Mean (Full Range). Unit: degrees

Measure	Percutaneous Epidural Stimulation n = 2
Difference in maximum knee flexion between Baseline and End of Study with ES off	15.5 (1 to 30)
Difference in maximum knee flexion at End of Study between ES off and ES on	10 (4 to 16)

Primary outcome: Static Balance, Eyes-open.

Time frame: Baseline and 4 weeks. Number. Unit: percent change

Measure	Percutaneous Epidural Stimulation n = 2
Difference in postural sway area between Baseline (ES off) and End of Study (ES off), eyes open	-50
Difference in postural sway area between Baseline (ES off) and End of Study (ES off), eyes closed	-90
Difference in postural sway area between End of Study (ES off) and End of Study (ES on), eyes open	-29
Difference in postural sway area between End of Study (ES off) and End of Study (ES on), eyes closed	-54

Primary outcome: Electromyography (EMG)

Time frame: End of Study (4 weeks). Mean (Full Range). Unit: percent change

Measure	Percutaneous Epidural Stimulation n = 2
Change in voltage measurements of rectus femoris at End of Study, between ES on and ES off	-7 (-14 to 0)
Change in voltage measurements of hamstring at End of Study, between ES on and ES off	20 (0 to 40)

Primary outcome: Spasticity, Knee Extensors (1)

Time frame: End of Study (4 weeks). Mean (Full Range). Unit: degrees

Measure	Percutaneous Epidural Stimulation n = 2
Value	6.5 (5 to 8)

10 secondary outcomes are reported in the full results.

Adverse events

Time frame: 4 weeks.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Percutaneous Epidural Stimulation	0 of 2 (0%)	2 of 2 (100%)	0 of 2

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 42112095Jahanian O, Asp AJ, Gill ML, Veith DD, Fernandez KA, Hogen CA, Mills CJ, Thoreson AR, Solinsky R, Kaufman KR, Grahn PJ, Zhao KD, Tobin WO. Percutaneous spinal stimulation to enhance gait and alleviate functional impairments in multiple sclerosis: A pilot study. Mult Scler J Exp Transl Clin. 2026 Apr 29;12(2):20552173261432301. doi: 10.1177/20552173261432301. eCollection 2026 Apr-Jun.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Percutaneous epidural stimulation in people with Multiple Sclerosis and Demyelinating Disorder, run by Kristin Zhao, PhD at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Kinematics (time frame: Baseline and 4 weeks.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06019611, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2025.