NCT06410001 CE-STAND: Cervical Epidural STimulation After Neurologic Damage
| NCT ID | NCT06410001 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | University of Minnesota |
| Condition | Spinal Cord Injury |
| Study Type | INTERVENTIONAL |
| Enrollment | 36 participants |
| Start Date | 2026-03-15 |
| Primary Completion | 2030-05-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 36 participants in total. It began in 2026-03-15 with a primary completion date of 2030-05-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Ann Parr, MD, PhD
PRINCIPAL INVESTIGATOR
University of Minnesota
Frequently Asked Questions
Who can join the NCT06410001 clinical trial?
This trial is open to participants of all sexes, aged 22 Years or older, studying Spinal Cord Injury. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06410001 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06410001 currently recruiting?
Yes, NCT06410001 is actively recruiting participants. Contact the research team at ce-stand@umn.edu for enrollment information.
Where is the NCT06410001 trial being conducted?
This trial is being conducted at Minneapolis, United States.
Who is sponsoring the NCT06410001 clinical trial?
NCT06410001 is sponsored by University of Minnesota. The principal investigator is Ann Parr, MD, PhD at University of Minnesota. The trial plans to enroll 36 participants.