N/A
N=2
Epidural Stimulation in Multiple Sclerosis
Multiple Sclerosis · Demyelinating Disorder · Autoimmune Diseases
Bottom Line
View on ClinicalTrials.gov: NCT06019611 ↗Enrolled (actual)
2
Serious AEs
0.0%
Results posted
Apr 2025
Primary outcome: Primary: Kinematics — 15.5; 10 degrees
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Percutaneous epidural stimulation (Device)
- Age
- Adult, Older Adult · 22+ yrs
- Sex
- All
- Sponsor
- Kristin Zhao, PhD
- Primary completion
- Feb 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Kinematics |
15.5; 10 | — |
| PRIMARY Static Balance, Eyes-open. |
-50; -90; -29; -54 | — |
| PRIMARY Electromyography (EMG) |
-7; 20 | — |
| PRIMARY Spasticity, Knee Extensors (1) |
6.5 | — |
| PRIMARY Spasticity, Knee Extensors (2) |
2; 1.5; 2; 0; 1.5; 1.5 | — |
| SECONDARY Overground Ambulation |
-25; 15 | — |
| SECONDARY Disability |
68; 72; 56; 50 | — |
| SECONDARY Fatigue |
30; 30; 30; 34 | — |
| SECONDARY Pain, Overall |
17; 18; 19; 16 | — |
| SECONDARY Bladder Control |
1; 0; 2; 13 | — |
| SECONDARY Bowel Control |
1; 0; 5; 9 | — |
| SECONDARY Impact of Visual Impairment |
3; 0; 0; 0 | — |
| SECONDARY Cognitive Dysfunction |
0; 0; 2; 9 | — |
| SECONDARY Mental Health |
78; 98; 73; 53 | — |
| SECONDARY Social Support |
66; 89; 63; 70 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT06019611). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.