CE-STAND: Cervical Epidural STimulation After Neurologic Damage

University of Minnesota (UMN)

Status and phase

Begins enrollment this month

Phase 2

Phase 1

Conditions

Spinal Cord Injury

Treatments

Device: Epidural Spinal Cord Stimulation System

Study type

Interventional

Funder types

Other

Identifiers

NCT06410001

NEUROSURG-2023-31800

Details and patient eligibility

About

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.

Full description

Spinal cord injury (SCI) affects over 18,000 individuals annually, leading to significant motor and autonomic dysfunctions that reduce quality of life (QoL). Epidural spinal cord stimulation (eSCS) has shown potential in restoring function in chronic individuals with SCI. However, research on cervical, and autonomic dysfunction-related SCI remains limited. This study will assess the safety and efficacy of eSCS in improving autonomic and volitional functions, as well as truncal stability, bowel, bladder, and sexual function, and overall QoL.

The study is a Phase I/II trial in which participants will serve as their own controls. The Abbott Eterna epidural stimulator system will be implanted, and assessments will occur every three months. The study will be conducted over a period of four years. A total of 36 participants will be enrolled and followed for one year.

Bayesian Optimization will be used to determine the most effective stimulation settings, with 15 settings programmed at the end of each visit.

FDA and UMN IRB approvals have been secured for the study. Interim reports will be made available through peer-reviewed journals, conference presentations, and clinical network reporting.

CE-STAND seeks to advance SCI treatment by expanding eSCS applications in chronic cervical SCI, improving patient outcomes, and reducing healthcare costs.

Enrollment

36 estimated patients

Sex

All

Ages

22+ years old

Volunteers

No Healthy Volunteers

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