How spinal cord stimulation affects blood pressure, immune, and heart function after spinal cord injury
Acute and Chronic Repercussion of Spinal Cord Stimulation After Spinal Cord Injury
This research will test whether spinal cord stimulation can change blood pressure control and immune and heart function in adults with spinal cord injury.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | All |
| Sponsor | Mayo Clinic Academic / other |
| Locations | 1 site (Rochester, Minnesota) |
| Trial ID | NCT07210411 on ClinicalTrials.gov |
What this trial studies
This interventional protocol will use epidural and transcutaneous spinal cord stimulation along with controlled tests that trigger sympathetic inhibition and activation to measure cardiovascular and immune responses. Participants include adults aged 18–50 with spinal cord injuries at levels C6–T8 more than six months after injury, plus uninjured controls. The team will compare responses in people with and without implanted epidural stimulators and will record blood pressure regulation, heart function markers, and immune measures during the stimulation and challenge tests. All visits are conducted in person at Mayo Clinic in Rochester, Minnesota.
Who should consider this trial
Good fit: Ideal candidates are adults 18–50 years old with a C6–T8 spinal cord injury at least six months old (AIS A–D), including those with or without implanted epidural stimulators.
Not a fit: People with injuries below T8, less than six months since injury, or outside the 18–50 age range would not be eligible and are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the approach could lead to new ways to stabilize blood pressure and improve cardiovascular and immune health after spinal cord injury.
How similar studies have performed: Early clinical work using epidural or transcutaneous stimulation has shown promising improvements in blood pressure regulation after spinal cord injury, but effects on immune function remain largely untested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria * Age 18-50. * American Spinal Injury Association Impairment Scale A-D,64 to encompass a representational spectrum of autonomic dysfunction after spinal cord injury. * Neurological level of injury, C6-T8, as defined by the International Standards for Neurological Classification of Spinal Cord Injury.64 Incorporating level of injury over this broad range to capture the spectrum of autonomic dysfunction. Individuals with injuries below T8 will not be included to ensure transcutaneous spinal cord stimulation does not occur over the injury/glial scar, where it may have altered properties. The C6 level was chosen to ensure hand cold pressor stimuli triggers above level sympathetic activation. * Time since injury of greater than six months, given early changes in spinal cord connectivity and recovery prior to this. * Both individuals with and without currently implanted epidural spinal cord stimulators will be enrolled. * Twenty uninjured controls will also be enrolled. Exclusion criteria * History of clinically diagnosed cardiovascular disease, diabetes, autonomic neuropathies, neurological disorders (with exception of spinal cord injury for individuals in those cohorts), or are active smokers. * Individuals who are taking betablockers, antihypertensives, or other sympathetically active medications which they are unable to hold. * Women who are pregnant or lactating, given known hormonal influences on autonomic regulation.65,66 * Cognitive issues preventing informed consent for participation. * Body mass index \>30 kg/m2 for the uninjured controls only given increased risk of prediabetes and potential confounding normative values. * 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.