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NCT06019611Completed

Epidural Stimulation in Multiple Sclerosis

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

Source: ClinicalTrials.gov · Last updated 27 Apr 2025

Brief summary (registry, in English)

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

Status (registry)
Completed
Study type
Interventional
Enrollment
2 (actual)
First submitted
2 Aug 2023
Start date
11 Sept 2023
Primary completion date
27 Feb 2024
Lead sponsor
Kristin Zhao, PhD
NCT number
NCT06019611

What you commit to

  • Study type: Interventional
  • Participants enrolled: 2
  • From 11 Sept 2023 to the primary completion date, 27 Feb 2024
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Receiving diathermy treatment

Other illness

  • History of chronic and/or treatment resistant urinary tract infection
  • Unhealed decubitus ulcer
  • 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
  • Diagnosed with cardiopulmonary dysfunction (e.g., chronic obstructive pulmonary disease, cardiac failure, or heart arrhythmia)
  • History of frequent hypotension characterized by light headedness, or loss of consciousness
  • History of frequent hypertension characterized by headache, or bradycardia

Other

  • Currently a prison inmate, or awaiting trial, related to criminal activity
  • Pregnancy at the time of enrollment
  • 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 skeletal fracture
  • Active participation in an interventional clinical trial
  • Ventilator-dependent respiration
  • Untreated clinical diagnosis of depression
  • Any active, implanted medical device
  • Treatment of chemodenervation and/or neurolysis during the trial, or within 6 months of initiating the trial

Who the study is looking for

  • 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

Age in the registry: 22 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Mayo Clinic
Coordinator of this site? Confirm its status
RochesterUnited StatesUnknown status

Related publications

This page is information, not medical advice. Discuss any trial with your doctor.