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Epidural Stimulation in Multiple Sclerosis

Primary Purpose

Multiple Sclerosis, Demyelinating Disorder, Autoimmune Diseases

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Percutaneous epidural stimulation
Sponsored by
Kristin Zhao, PhD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Multiple Sclerosis

Eligibility Criteria

22 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Mayo ClinicRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Percutaneous Epidural Stimulation

Arm 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.

Outcomes

Primary Outcome Measures

Kinematics
Change in measurements of joint angles, measured in degrees.
Kinetics
Change in measurement of movement force and pressure, measured in kilograms
Electromyography (EMG)
Change in voltage measurements in major muscle groups of the lower extremities.
Spasticity (1)
Change in measurements of leg muscle tone utilizing Wartenberg's pendulum test, with tone measured via electromyography.
Spasticity (2)
Change in measurement of leg muscle tone utilizing the Modified Ashworth Scale (MAS). A physical therapist will use a 5-point scale to assess resistance of major muscles during passive range of motion, with a lower score for a muscle indicating less tone.

Secondary Outcome Measures

Overground ambulation (1)
Measurement of changes in overground mobility as measured by the Timed 25-Foot Walk (T25-FW). Trainers will record the time in seconds in which the subject can cover 25 feet, with a lower score characterizing better overground mobility.
Overground ambulation (2)
Measurement of changes in overground mobility as measured by the Timed Up and Go (TUG). Trainers will record the time in seconds in which the subject can stand from a seated position in a chair, traverse 3 meters, turn around, return to the chair, and sit back down. A lower score characterizes better overground mobility.
Balance
Measurement of changes in ability to perform 14 activities of daily life requiring balance using the Berg Balance Scale. Trainers will assess capabilities in all categories on a 0 to 4 scale, with a higher number indicating greater capability, and total the scores, with a higher total score indicating greater overall balance.
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.
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.
Pain
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 fatigue and a score of 84 equivalent to maximum fatigue.
Sexual Satisfaction
Measurement of changes in patient-reported sexual satisfaction, utilizing the Sexual Satisfaction Scale (SSS). Items are scaled so that lower scores indicate a greater degree of satisfaction with aspects of the person's sex life. The total SSS score can range from 4 to 24, with a score of 4 equivalent to extreme satisfaction and a score of 24 equivalent to extreme dissatisfaction.
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.
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.
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.
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.
Mental Health
Measurement of changes in patient-reported psychological distress and psychological well-being, utilizing the Mental Health Inventory (MHI). Items are scaled so that higher scores indicate less psychological distress. The raw score range is 38-226, with higher scores equivalent to less psychological distress and greater psychological well-being.
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.

Full Information

First Posted
August 2, 2023
Last Updated
October 23, 2023
Sponsor
Kristin Zhao, PhD
Collaborators
Mayo Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT06019611
Brief Title
Epidural Stimulation in Multiple Sclerosis
Official Title
A Pilot Study to Explore the Use of Percutaneous Spinal Stimulation in Participants With Multiple Sclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 11, 2023 (Actual)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
September 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Kristin Zhao, PhD
Collaborators
Mayo Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis, Demyelinating Disorder, Autoimmune Diseases

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Percutaneous Epidural Stimulation
Arm Type
Experimental
Arm 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.
Intervention Type
Device
Intervention Name(s)
Percutaneous epidural stimulation
Intervention Description
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
Primary Outcome Measure Information:
Title
Kinematics
Description
Change in measurements of joint angles, measured in degrees.
Time Frame
Through study completion; approximately 4 weeks.
Title
Kinetics
Description
Change in measurement of movement force and pressure, measured in kilograms
Time Frame
Through study completion; approximately 4 weeks.
Title
Electromyography (EMG)
Description
Change in voltage measurements in major muscle groups of the lower extremities.
Time Frame
Through study completion; approximately 4 weeks.
Title
Spasticity (1)
Description
Change in measurements of leg muscle tone utilizing Wartenberg's pendulum test, with tone measured via electromyography.
Time Frame
Through study completion; approximately 4 weeks.
Title
Spasticity (2)
Description
Change in measurement of leg muscle tone utilizing the Modified Ashworth Scale (MAS). A physical therapist will use a 5-point scale to assess resistance of major muscles during passive range of motion, with a lower score for a muscle indicating less tone.
Time Frame
Through study completion; approximately 4 weeks.
Secondary Outcome Measure Information:
Title
Overground ambulation (1)
Description
Measurement of changes in overground mobility as measured by the Timed 25-Foot Walk (T25-FW). Trainers will record the time in seconds in which the subject can cover 25 feet, with a lower score characterizing better overground mobility.
Time Frame
Through study completion; approximately 4 weeks.
Title
Overground ambulation (2)
Description
Measurement of changes in overground mobility as measured by the Timed Up and Go (TUG). Trainers will record the time in seconds in which the subject can stand from a seated position in a chair, traverse 3 meters, turn around, return to the chair, and sit back down. A lower score characterizes better overground mobility.
Time Frame
Through study completion; approximately 4 weeks.
Title
Balance
Description
Measurement of changes in ability to perform 14 activities of daily life requiring balance using the Berg Balance Scale. Trainers will assess capabilities in all categories on a 0 to 4 scale, with a higher number indicating greater capability, and total the scores, with a higher total score indicating greater overall balance.
Time Frame
Through study completion; approximately 4 weeks.
Title
Disability
Description
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.
Time Frame
Through study completion; approximately 4 weeks.
Title
Fatigue
Description
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.
Time Frame
Through study completion; approximately 4 weeks.
Title
Pain
Description
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 fatigue and a score of 84 equivalent to maximum fatigue.
Time Frame
Through study completion; approximately 4 weeks.
Title
Sexual Satisfaction
Description
Measurement of changes in patient-reported sexual satisfaction, utilizing the Sexual Satisfaction Scale (SSS). Items are scaled so that lower scores indicate a greater degree of satisfaction with aspects of the person's sex life. The total SSS score can range from 4 to 24, with a score of 4 equivalent to extreme satisfaction and a score of 24 equivalent to extreme dissatisfaction.
Time Frame
Through study completion; approximately 4 weeks.
Title
Bladder Control
Description
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.
Time Frame
Through study completion; approximately 4 weeks.
Title
Bowel Control
Description
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.
Time Frame
Through study completion; approximately 4 weeks.
Title
Impact of Visual Impairment
Description
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.
Time Frame
Through study completion; approximately 4 weeks.
Title
Cognitive Dysfunction
Description
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.
Time Frame
Through study completion; approximately 4 weeks.
Title
Mental Health
Description
Measurement of changes in patient-reported psychological distress and psychological well-being, utilizing the Mental Health Inventory (MHI). Items are scaled so that higher scores indicate less psychological distress. The raw score range is 38-226, with higher scores equivalent to less psychological distress and greater psychological well-being.
Time Frame
Through study completion; approximately 4 weeks.
Title
Social Support
Description
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.
Time Frame
Through study completion; approximately 4 weeks.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Carol M. Denny
Phone
507-422-9337
Email
denny.carol@mayo.edu
Facility Information:
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carol M. Denny
Phone
507-422-9337
Email
denny.carol@mayo.edu
First Name & Middle Initial & Last Name & Degree
William O. Tobin, MBBCh, Ph.D.
First Name & Middle Initial & Last Name & Degree
Kristin D. Zhao, Ph.D.
First Name & Middle Initial & Last Name & Degree
Megan L. Gill, P.T., D.P.T.
First Name & Middle Initial & Last Name & Degree
Peter J. Grahn, Ph.D.

12. IPD Sharing Statement

Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials

Learn more about this trial

Epidural Stimulation in Multiple Sclerosis

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