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.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
CE-STAND: Cervical Epidural STimulation After Neurologic Damage
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- 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
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- 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.