Percutaneous Spinal Stimulation in Participants with Multiple Sclerosis

Overview

About this study

The purpose of this study is to evaluate the effectiveness of percutaneous epidural spinal stimulation (ES) and task-specific training over 1 month in participants with Progressive MS to impact motor function and spasticity.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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 21 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.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 4/13/23. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Kristin Zhao, Ph.D., M.S.

Open for enrollment

Contact information:

Julie Block

(507) 255-7393

Block.Julie@mayo.edu

More information

Publications

Publications are currently not available