Tracking autonomic blood-pressure changes after spinal cord injury to predict complications
Longitudinal Autonomic Characterization as a Predictor for Secondary Medical Complications Post-SCI
NA · Mayo Clinic · NCT07210437
We will test whether tracking blood pressure and autonomic responses over time in adults with C6–T12 spinal cord injuries can help predict later medical complications.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 18 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Mayo Clinic (other) |
| Locations | 1 site (Rochester, Minnesota) |
| Trial ID | NCT07210437 on ClinicalTrials.gov |
What this trial studies
This interventional protocol at Mayo Clinic enrolls adults with cervical-to-thoracic (C6–T12) spinal cord injuries, including both acute (<3 months) and chronic (>1 year) participants. Subjects undergo standardized autonomic testing including sympathetic inhibition and above-level and below-level sympathetic activation with repeated measurements over time. Some tests involve vasoactive provocation (e.g., phenylephrine) and physiologic maneuvers while monitoring safety and cardiovascular responses. The study aims to link longitudinal patterns of autonomic regulation to the risk of developing secondary medical complications using a small, deeply phenotyped cohort.
Who should consider this trial
Good fit: Adults 18–75 with a spinal cord injury from C6 to T12 (ASIA A–D), either within 3 months of injury or more than 1 year post-injury, who are medically stable and can undergo autonomic testing are ideal candidates.
Not a fit: Individuals with active cardiovascular, respiratory, peripheral neurological, or autonomic disease, pregnant or lactating women, or those taking medications that interact with phenylephrine are unlikely to be eligible or to receive benefit from participation.
Why it matters
Potential benefit: If successful, this approach could help clinicians identify people at higher risk for blood-pressure–related complications after SCI so they can receive earlier monitoring or preventive care.
How similar studies have performed: Prior studies have shown autonomic dysfunction after SCI and associations with complications, but using longitudinal pharmacologic and physiologic autonomic testing to predict future medical events is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria * 18-75 years old * Spinal cord injury with neurological level of injury from C6-T12 * ASIA Impairment Scale A-D. * Either acute SCI \<3 months prior (n=10) or chronic SCI (\>1 year since injury, n=8). Exclusion criteria * Symptoms of cardiovascular (including, but not limited to: hypertension, stroke, chest pain, etc.), respiratory, peripheral neurological or autonomic disease (particularly diabetes mellitus requiring treatment); * Women who are pregnant or lactating * Taking or being administered a medication known to potentially have adverse interactions with phenylephrine * In the judgement of the principal investigator, any illness or condition that will interfere with the patient's ability to comply with the protocol, compromise patient safety, or interfere with the interpretation of the study results.
Where this trial is running
Rochester, Minnesota
- Mayo Clinic — Rochester, Minnesota, United States (RECRUITING)
Study contacts
- Principal investigator: Ryan Solinsky, MD — Mayo Clinic
- Study coordinator: Zachary Pohlkamp
- Email: pohlkamp.zachary@mayo.edu
- Phone: 507-422-0140
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Spinal Cord Injuries