Epidural Stimulation in Multiple Sclerosis

Browse trials for

• Multiple Sclerosis 3,264
• Demyelinating Diseases 103
• Autoimmune Diseases 802

Multiple Sclerosis

3,264 studies on the registry are indexed under Multiple Sclerosis; 659 are open to participants now.

This study's enrollment of 2 is below the median of 50 across 2,201 interventional studies indexed under Multiple Sclerosis.

Lead sponsor

Kristin Zhao, PhD is the lead sponsor of 7 studies on the registry; none are open to participants now.

Study arms

• Experimental
  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.

  Device: Percutaneous epidural stimulation

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

Primary outcomes

1. 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.

2. 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.

   Time frame: Baseline and 4 weeks

3. 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)

4. 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)

5. 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)

Secondary outcomes

1. 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.

   Time frame: Baseline and 4 weeks

2. 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.

   Time frame: Baseline and 4 weeks

3. 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.

   Time frame: Baseline and 4 weeks

4. 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.

   Time frame: Baseline and 4 weeks

5. 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.

   Time frame: Baseline and 4 weeks

6. 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.

   Time frame: Baseline and 4 weeks

7. 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.

   Time frame: Baseline and 4 weeks

8. 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.

   Time frame: Baseline and 4 weeks

9. 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.

   Time frame: Baseline and 4 weeks

10. 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.

    Time frame: Baseline and 4 weeks

Baseline characteristics

Study documents

• Protocol and statistical analysis plan ↗ · Dec 5, 2023

PDFs hosted by the registry, ClinicalTrials.gov.