Status:
COMPLETED
Epidural and Dorsal Root Stimulation in Humans With Spinal Cord Injury
Lead Sponsor:
Peter J. Grahn, Ph.D.
Collaborating Sponsors:
National Institute of Neurological Disorders and Stroke (NINDS)
Conditions:
Spinal Cord Injuries
Paraplegia
Eligibility:
All Genders
22+ years
Phase:
NA
Brief Summary
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 co...
Detailed Description
This study aims to expand the understanding of how electrical spinal stimulation enables function, specifically the pathophysiological mechanisms of action underlying spinal electrical stimulation aft...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
September 24 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 19 2025
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT04736849
Start Date
September 24 2021
End Date
March 19 2025
Last Update
August 8 2025
Active Locations (1)
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1
Mayo Clinic
Rochester, Minnesota, United States, 55905