RecruitingPhase 1Phase 2NCT06410001

CE-STAND: Cervical Epidural STimulation After Neurologic Damage

Sponsor

University of Minnesota

Enrollment

36 participants

Start Date

Mar 15, 2026

Study Type

INTERVENTIONAL

Conditions

Spinal Cord Injury

Summary

CE-STAND aims to address three areas under-represented in research: chronic, cervical, and autonomic dysfunction. It is both significant and highly impactful, as treating autonomic dysfunction could substantially improve function and quality of life (QoL) in chronic cervical SCI patients.

Eligibility

Min Age: 22 Years

Inclusion Criteria10

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 Criteria17

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