Comparing epidural and dorsal root stimulation for spinal cord injury recovery
Pilot Study of Epidural and Dorsal Root Stimulation in Humans With Spinal Cord Injury
This study is testing whether two types of electrical stimulation can help people with spinal cord injuries improve their movement and recovery during rehabilitation sessions.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 32 (estimated) |
| Ages | 22 Years and up |
| Sex | All |
| Sponsor | Mayo Clinic Academic / other |
| Locations | 1 site (Rochester, Minnesota) |
| Trial ID | NCT04736849 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of two types of electrical spinal stimulation—epidural and dorsal root ganglion stimulation—on motor performance in individuals with spinal cord injuries. Participants will undergo 10 rehabilitation sessions where their electrophysiologic activity will be monitored to understand the mechanisms of action behind spinal electrical stimulation. The goal is to enhance knowledge of how these stimulation techniques can improve function and recovery in patients with spinal cord injuries.
Who should consider this trial
Good fit: Ideal candidates are adults aged 22 and older with spinal cord injuries due to trauma at or above the tenth thoracic vertebrae and intact spinal reflexes.
Not a fit: Patients with unhealed injuries, certain psychiatric disorders, or incompatible medical devices may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved rehabilitation strategies for individuals with spinal cord injuries, enhancing their motor function and quality of life.
How similar studies have performed: Other studies have shown promise with spinal stimulation techniques, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion 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 Exclusion Criteria: * 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 this trial is running
Rochester, Minnesota
- Mayo Clinic — Rochester, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: Peter J. Grahn, Ph.D. — Mayo Clinic
- Study coordinator: Julie B. Block
- Email: block.julie@mayo.edu
- Phone: 507-255-7393
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.