Epidural and Dorsal Root Stimulation in Humans With Spinal Cord Injury

Description

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.

Conditions

Spinal Cord Injuries, Paraplegia, Tetraplegia, Paralysis

Study Overview

Study Details

Study overview

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.

Pilot Study of Epidural and Dorsal Root Stimulation in Humans With Spinal Cord Injury

Epidural and Dorsal Root Stimulation in Humans With Spinal Cord Injury

Condition
Spinal Cord Injuries
Intervention / Treatment

-

Contacts and Locations

Rochester

Mayo Clinic, Rochester, Minnesota, United States, 55905

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Spinal cord injury due to trauma located at or above 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
  • * Currently a prison inmate, or awaiting trial, related to criminal activity
  • * Pregnancy at the time of screening for trial enrollment
  • * Active, untreated urinary tract infection
  • * 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
  • * Non-MRI-compatible implanted medical devices
  • * Other implanted stimulation devices (e.g. deep brain stimulator, cardiac pacemaker, diaphragmatic pacer, etc.)
  • * 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

Ages Eligible for Study

22 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Peter J. Grahn, Ph.D.,

Peter J. Grahn, Ph.D., PRINCIPAL_INVESTIGATOR, Mayo Clinic

Study Record Dates

2025-10