How spinal cord stimulation affects blood pressure, immune, and heart function after spinal cord injury

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Mayo Clinic
  Rochester, Minnesota, United States Recruiting

Study contacts

• Principal investigator: Ryan J. Solinsky, MD — Mayo Clinic
• Study coordinator: Erin Lund
• Email: lund.erin@mayo.edu
• Phone: 507-284-9298

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.