CE-STAND: Cervical Epidural Stimulation for Spinal Cord Injury

This study, called CE-STAND, is testing a device called the Abbott Eterna system. This system involves an implantable pulse generator (IPG) and a lead that delivers epidural spinal cord stimulation (eSCS). Researchers want to see if this stimulation can help improve function and quality of life for people with chronic spinal cord injury (SCI) in the neck (cervical area), especially those with problems like autonomic dysfunction (issues with automatic body functions like blood pressure or bladder control). The main goal is to check the safety of the stimulator over one year. You might be able to join if you are at least 22 years old, have a stable and complete SCI between C4 and C7 (meaning weakness in your upper body), and it's been more than a year since your injury. The study is currently unclear on its recruitment status and plans to enroll 36 participants.

Study design
This is a Phase I/II interventional study where participants will serve as their own controls. A total of 36 participants will be enrolled.
What's involved
You would have the Abbott Eterna epidural stimulator system implanted. Assessments will take place every three months over a period of one year.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for one year after the stimulator is implanted to assess its safety.

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NCT06410001

CE-STAND: Cervical Epidural STimulation After Neurologic Damage

Recruiting
PHASE1Ages 22+InterventionalTreatment
University of Minnesota
~36 participants
Updated 2026-03-27 on ClinicalTrials.gov
What's tested:Epidural Spinal Cord Stimulation System

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety of epidural spinal cord stimulator in chronic cervical patients
Measured over 1 year
Spinal Cord Injury
1 sites across 1 states
Minnesota1
  • Ann Parr, MD, PhD · PRINCIPAL_INVESTIGATOR · University of Minnesota
  • Manda Keller-Ross, PhD, DPT, PT · PRINCIPAL_INVESTIGATOR · University of Minnesota
  • Nadine Mansour, MD, MPH, PhD · PRINCIPAL_INVESTIGATOR · University of Minnesota

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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
  • Safety of epidural spinal cord stimulator in chronic cervical patients1 year

    Incidence of adverse events (AEs) and serious adverse events (SAEs) including hypotension, other hemodynamic instability, infection, bleeding, significant pain, spasticity, or cerebrospinal fluid leak.