Cervical epidural stimulation to improve autonomic and voluntary function after spinal cord injury
CE-STAND: Cervical Epidural STimulation After Neurologic Damage
PHASE1; PHASE2 · University of Minnesota · NCT06410001
This trial will test an implanted cervical epidural stimulator to see if it improves autonomic control, trunk stability, and voluntary movement in adults with chronic motor-complete cervical spinal cord injuries.
Quick facts
| Phase | PHASE1; PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 36 (estimated) |
| Ages | 22 Years and up |
| Sex | All |
| Sponsor | University of Minnesota (other) |
| Drugs / interventions | radiation |
| Locations | 1 site (Minneapolis, Minnesota) |
| Trial ID | NCT06410001 on ClinicalTrials.gov |
What this trial studies
CE-STAND is a Phase I/II, single-site trial at the University of Minnesota that implants the Abbott Eterna epidural stimulator in adults with chronic motor-complete cervical spinal cord injuries (C4–C7). Participants serve as their own controls and will undergo programming with Bayesian optimization to identify up to 15 stimulation settings at the end of each visit, with assessments every three months and a one-year follow-up. The trial will measure autonomic outcomes (blood pressure regulation, bowel/bladder/sexual function), volitional motor control, truncal stability, and overall quality of life, while monitoring safety. A total of 36 participants will be enrolled over a four-year enrollment period.
Who should consider this trial
Good fit: Ideal candidates are medically stable adults (≥22 years) with chronic (>1 year), motor-complete cervical SCI between C4 and C7 (ASIA A or B), intact segmental reflexes below the lesion, and the ability to undergo surgery and attend regular clinic visits.
Not a fit: Patients who require ventilatory support, have unstable cardiopulmonary disease, cannot safely stop anticoagulation, have recent spinal instrumentation, or have non-cervical or non-motor-complete injuries are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, the implanted stimulator could improve blood pressure control, bladder/bowel/sexual function, trunk stability, and voluntary movement, producing substantial quality-of-life gains.
How similar studies have performed: Prior work with epidural stimulation at thoracolumbar levels has produced some restoration of volitional movement and autonomic improvements, but cervical and autonomic-targeted eSCS is less tested and more novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Twenty two years of age or older * Able to undergo the informed consent/assent process * Stable, motor-complete SCI * Discrete SCI between C4 and C7 (upper extremity weakness) * ASIA A or B SCI Classification * Medically stable in the judgment of the PI * Intact segmental reflexes below the lesion of injury * Greater than 1 year since initial injury and at least 6 months from any required spinal instrumentation * Normal or corrected-to-normal vision to accurately perceive visual stimuli on the N-back task screen, and sufficient hearing ability to accurately perceive auditory stimuli during the task * Willing to attend all scheduled appointments Exclusion Criteria: * Diseases and conditions that would increase the morbidity and mortality of this surgery such as cardiopulmonary. * Individuals who require respiratory support, including ongoing or intermittent use of a ventilator and/or diaphragmatic pacer * Inability to withhold antiplatelet/anticoagulation agents perioperatively * Individuals who have history of recurrent autonomic dysreflexia in the judgment of the PI * Significant dysautonomia that would prohibit rehabilitation or any history of cerebrovascular accident or myocardial infarction associated with autonomic dysreflexia. A single tilt table test with syncope, presyncope, or SBP \< 50 or \> 200 * Failure to exhibit cardiovascular autonomic dysfunction on tilt table testing * Other conditions that would make the subject unable to participate in testing/rehabilitation in the judgment of the PI * Patients who have participated in another study within the last 12 months in which they have received fluoroscopic or other related radiation exposure * Current and anticipated need for opioid pain medications or pain that would prevent full participation in the program in the judgment of the PI * Clinically significant mental illness in the judgment of the PI * Treatment with botulinum toxin, intrathecal baclofen pump, and antispasmodics will not be permitted unless discussed with and approved by the study PI * Patients with a history of significant depression or drug abuse * Volitional movements present during EMG testing in bilateral lower extremities * Unhealed spinal fracture * Presence of significant contracture with loss of greater than two-thirds range of motion * Presence of pressure ulcers * Current Pregnancy
Where this trial is running
Minneapolis, Minnesota
- University of Minnesota — Minneapolis, Minnesota, United States (RECRUITING)
Study contacts
- Principal investigator: Ann Parr, MD, PhD — University of Minnesota
- Study coordinator: Ann Parr, MD, PhD
- Email: ce-stand@umn.edu
- Phone: 612-625-4102
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.
Conditions: Spinal Cord Injury, Cervical, Spinal cord injury, Epidural spinal cord stimulation, Autonomic dysfunction