Cervical epidural stimulation to improve autonomic and voluntary function after spinal cord injury

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.