NCT06410001 · University of Minnesota
CE-STAND: Cervical Epidural STimulation After Neurologic Damage
What this study is 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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Minneapolis, Minnesota
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 27, 2026 · Source of record for eligibility and locations