Epidural and Dorsal Root Stimulation in Humans With Spinal Cord Injury

Completed · Not applicable

Conditions studied: Spinal Cord Injuries, Paraplegia, Tetraplegia, Paralysis

In brief

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.

Key facts

Study ID

NCT04736849

Run by

Peter J. Grahn, Ph.D.

People needed

22

Starts

2021-09-24

Expected to finish

2025-03-19

Last updated by the study team

2026-07-16

Who can join

Age: 22 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Mayo Clinic — Rochester, Minnesota, United States

Full record on ClinicalTrials.gov

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