Spinal Cord Stimulation and Blood Pressure Control After Spinal Cord Injury

This study is looking at how your body controls blood pressure after a spinal cord injury, and how spinal cord stimulation (either implanted or worn on the skin) affects this control, as well as your immune system and heart health. Researchers will use various tests, like a cold pressor test (placing your hand or foot in cold water) or a Valsalva maneuver (trying to breathe out with your mouth and nose closed), to see how your body responds. You may be able to join if you are 18-50 years old, have a spinal cord injury classified as ASIA A-D, and your injury is between C6 and T8. The main goal is to understand how the Valsalva maneuver affects your blood pressure during these tests. The study is currently unclear on its recruitment status and plans to enroll 80 participants.

Study design
This is an interventional study, meaning you will receive specific tests and interventions. It plans to enroll 80 participants.
What's involved
You will undergo diagnostic testing sessions, which include various tests of sympathetic activity and blood pressure responses. The duration of these sessions is not specified.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint, Valsalva Maneuver Phase II, is measured during a single laboratory diagnostic testing session. No further follow-up is specified.

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NCT07210411

Acute and Chronic Repercussion of Spinal Cord Stimulation After Spinal Cord Injury

Recruiting
NAAges 18–50InterventionalDiagnostic
Mayo Clinic
~80 participants
Updated 2026-05-28 on ClinicalTrials.gov
What's tested:Tests of sympathetic inhibitionTests of above level sympathetic activationTesting of below level sympathetic activationEpidural stimulationTranscutaneous stimulation

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Valsalva Maneuver Phase II
Measured over During laboratory diagnostic testing session
Spinal Cord Injuries
1 sites across 1 states
Minnesota1
  • Ryan J. Solinsky, MD · PRINCIPAL_INVESTIGATOR · Mayo Clinic

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Eligibility criteria

Inclusion

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

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
  • Valsalva Maneuver Phase IIDuring laboratory diagnostic testing session

    Presence or absence of phase II on Valsalva maneuver testing, which takes approximately 15 seconds to complete. This will be repeated x3.