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| Name | Class |
|---|---|
| Mayo Clinic | OTHER |
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A study to quantify changes in motor performance of epidural stimulation in progressive multiple sclerosis (MS) patients over the course of 12 rehabilitation sessions.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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+). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and 4 weeks |
| Disability |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42112095 | Derived | 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. |
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Of 2 enrolled participants, 2 met inclusion criteria and proceeded to treatment.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Full Range | degrees | Baseline and 4 weeks. |
|
4 weeks.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Skin abrasion | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Kristin Zhao, Director of the Assistive and Restorative Technologies Laboratory | Mayo Clinic | 507-284-8942 | zhao.kristin@mayo.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 5, 2023 | Feb 25, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D007154 | Immune System Diseases |
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| End of Study (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. |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Baseline and 4 weeks |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
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|
| 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. | Posted | Number | percent change | Baseline and 4 weeks |
|
|
|
| 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. | Posted | Mean | Full Range | percent change | End of Study (4 weeks) |
|
|
|
| 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. | Posted | Mean | Full Range | degrees | End of Study (4 weeks) |
|
|
|
| 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+). | 1 participant analyzed per row. | Posted | Number | score on a scale | End of Study (4 weeks) |
|
|
|
| Secondary | 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. | Posted | Mean | Full Range | percent change | Baseline and 4 weeks |
|
|
|
| Secondary | 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. | 1 participant analyzed per row. | Posted | Number | score on a scale | Baseline and 4 weeks |
|
|
|
| Secondary | 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. | 1 participant analyzed per row. | Posted | Number | score on a scale | Baseline and 4 weeks |
|
|
|
| Secondary | 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. | 1 participant analyzed per row. | Posted | Number | score on a scale | Baseline and 4 weeks |
|
|
|
| Secondary | 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. | 1 participant analyzed per row. | Posted | Number | score on a scale | Baseline and 4 weeks |
|
|
|
| Secondary | 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. | 1 participant analyzed per row. | Posted | Number | score on a scale | Baseline and 4 weeks |
|
|
|
| Secondary | 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. | 1 participant analyzed per row. | Posted | Number | score on a scale | Baseline and 4 weeks |
|
|
|
| Secondary | 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. | 1 participant analyzed per row. | Posted | Number | score on a scale | Baseline and 4 weeks |
|
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|
| Secondary | 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. | 1 participant analyzed per row. | Posted | Number | score on a scale | Baseline and 4 weeks |
|
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| Secondary | 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. | 1 participant analyzed per row. | Posted | Number | score on a scale | Baseline and 4 weeks |
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| 0 |
| 2 |
| 0 |
| 2 |
| 2 |
| 2 |
| Knee pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Bladder incontinence | Renal and urinary disorders | Non-systematic Assessment |
|
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| Difference in postural sway area between End of Study (ES off) and End of Study (ES on), eyes closed |
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| Participant 1, left side, ES off |
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| Participant 1, left side, ES on |
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| Participant 2, right side, ES off |
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| Participant 2, right side, ES on |
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| Participant 2, left side, ES off |
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| Participant 2, left side, ES on |
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