Epidural Stimulation in Multiple Sclerosis

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

CompletedNot a drug-phase studyProgressive MSNCT06019611

What it found

Results posted, not judged

Results are posted in the registry, but without a statistical test of the main measure. See the numbers below.

What was tested

Treatment tested

  • Percutaneous epidural stimulation

Results by group

Kinematics

Baseline and 4 weeks.

GroupValueIntervalNumber analysed
Percutaneous Epidural Stimulation15.5 degrees1–302
Percutaneous Epidural Stimulation10 degrees4–162

Percutaneous Epidural Stimulation

15.5

Percutaneous Epidural Stimulation

10

Static Balance, Eyes-open.

Baseline and 4 weeks

GroupValueIntervalNumber analysed
Percutaneous Epidural Stimulation-50 percent change2
Percutaneous Epidural Stimulation-90 percent change2
Percutaneous Epidural Stimulation-29 percent change2
Percutaneous Epidural Stimulation-54 percent change2

Percutaneous Epidural Stimulation

-50

Percutaneous Epidural Stimulation

-90

Percutaneous Epidural Stimulation

-29

Percutaneous Epidural Stimulation

-54

Electromyography (EMG)

End of Study (4 weeks)

GroupValueIntervalNumber analysed
Percutaneous Epidural Stimulation-7 percent change-14–02
Percutaneous Epidural Stimulation20 percent change0–402

Percutaneous Epidural Stimulation

-7

Percutaneous Epidural Stimulation

20

Spasticity, Knee Extensors (1)

End of Study (4 weeks)

GroupValueIntervalNumber analysed
Percutaneous Epidural Stimulation6.5 degrees5–82

Spasticity, Knee Extensors (2)

End of Study (4 weeks)

GroupValueIntervalNumber analysed
Percutaneous Epidural Stimulation2 score on a scale2
Percutaneous Epidural Stimulation1.5 score on a scale2
Percutaneous Epidural Stimulation2 score on a scale2
Percutaneous Epidural Stimulation0 score on a scale2
Percutaneous Epidural Stimulation1.5 score on a scale2
Percutaneous Epidural Stimulation1.5 score on a scale2
Percutaneous Epidural Stimulation1.5 score on a scale2
Percutaneous Epidural Stimulation1 score on a scale2

Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.

Safety

GroupParticipants at riskSerious adverse eventsDeaths
Percutaneous Epidural Stimulation20 (0.0%)0

As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.

What it measured

Main measures

  • Kinematics

    Baseline and 4 weeks.

  • Static Balance, Eyes-open.

    Baseline and 4 weeks

    Walking and mobility

  • Electromyography (EMG)

    End of Study (4 weeks)

    Walking and mobility

  • Spasticity, Knee Extensors (1)

    End of Study (4 weeks)

    Spasticity

  • Spasticity, Knee Extensors (2)

    End of Study (4 weeks)

    MRI lesionsSpasticity

Other measures (10)

  • Overground Ambulation

    Baseline and 4 weeks

    Walking and mobility

  • Disability

    Baseline and 4 weeks

    Disability progressionQuality of life (reported by participants)

  • Fatigue

    Baseline and 4 weeks

    FatigueQuality of life (reported by participants)

  • Pain, Overall

    Baseline and 4 weeks

    PainQuality of life (reported by participants)

  • Bladder Control

    Baseline and 4 weeks

    Bladder, bowel and sexual functionQuality of life (reported by participants)

  • Bowel Control

    Baseline and 4 weeks

    Bladder, bowel and sexual functionQuality of life (reported by participants)

  • Impact of Visual Impairment

    Baseline and 4 weeks

    Quality of life (reported by participants)

  • Cognitive Dysfunction

    Baseline and 4 weeks

    Thinking and memoryQuality of life (reported by participants)

  • Mental Health

    Baseline and 4 weeks

    Quality of life (reported by participants)

  • Social Support

    Baseline and 4 weeks

    Quality of life (reported by participants)

Who could take part

Progressive MS · 22 and over

Show the full 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

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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

Papers

Loading reviews and guidelines…

History

    1. Started

      Sept 2023

    2. Main results due

      Feb 2024

    3. Finished

      Feb 2024

    4. Results posted

      Apr 2025

    Assembled by software from public sources.