Epidural and Dorsal Root Stimulation in Humans with Spinal Cord Injury

Overview

About this study

A study to compare electrophysiologic activity of epidural stimulation and dorsal root ganglion stimulation, as well as quantify changes in motor performance with both types of stimulation over the course of 10 rehabilitation sessions.

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:

  • Spinal cord injury due to trauma located between the seventh cervical vertebrae and the tenth thoracic vertebrae.
  • American Spinal Injury Association grading scale of A, B, C, or D.
  • Intact spinal reflexes below the level of SCI.
  • SCI must have occurred at least 1 year prior to study enrollment.
  • At least 22 years of age.
  • If female, must be willing to use medically-acceptable method of contraception during study participation.
  • Completed vaccination series for SARS-CoV-2.

Exclusion Criteria:

  • Currently a prison inmate, or awaiting trial, related to criminal activity.
  • Pregnancy at the time of screening for trial enrollment.
  • DEXA T-score of less than -3.5 at spine and femur head.
  • Active, untreated urinary tract infection.
  • Body mass > 113 kg (250 pounds).
  • Unhealed decubitus ulcer.
  • Unhealed skeletal fracture.
  • Spinal abnormality that may impede percutaneous implantation of spinal electrodes.
  • Untreated clinical diagnosis of psychiatric disorder.
  • Joint contractures that impede typical range of motion.
  • Modified Ashworth Spasticity score of 4 during impaired joint assessments.
  • Non-MRI-compatible implanted medical devices.
  • Undergoing, or planning to undergo, diathermy treatment.
  • Active participation in an interventional clinical trial.
  • History of clinically-diagnosed cardiopulmonary disorder, such as severe orthostatic hypotension, which may impede participation in rehabilitation activities such as changes in body position such as supine-to-sit-to-stand activities, prolonged standing, or stepping.
  • History of frequent and/or severe autonomic dysreflexia.
  • History of seizure disorder.
  • Any illness or condition which, based on the research team’s assessment, will compromise with the patient’s ability to comply with the protocol, patient safety, or the validity of the data collected during this study.

Eligibility last updated 9/22/21. 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

Peter Grahn, Ph.D.

Open for enrollment

Contact information:

Tyson Scrabeck CCRP

(507) 538-1016

Scrabeck.Tyson@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

.
CLS-20515966

Mayo Clinic Footer