NCT07210411 · Mayo Clinic
Acute and Chronic Repercussion of Spinal Cord Stimulation After Spinal Cord Injury
What this study is about
The purpose of this research is to learn about how the participant's body is able to balance changes in blood pressure, and how spinal cord stimulation affects these changes as well as immune \& cardiovascular function in participants with spinal cord injury.
View original scientific description
The purpose of this research is to learn about how the participant's body is able to balance changes in blood pressure, and how spinal cord stimulation affects these changes as well as immune \& cardiovascular function in participants with spinal cord injury.
Interventions
DIAGNOSTIC_TEST
Tests of sympathetic inhibition
Bolus phenylephrine infusion using the Oxford technique will generate the need to inhibit sympathetic activity. Similarly, resting state Mayer waves will be assessed with regard to heart rate and blood pressure responses.
DIAGNOSTIC_TEST
Tests of above level sympathetic activation
Cold pressor test of the hand will be used to cause sympathetic activation. Valsalva's maneuver will assess the ability to buffer against blood pressure fall (phase II).
DIAGNOSTIC_TEST
Testing of below level sympathetic activation
Cold pressor test of the foot and bladder pressor response (in individuals with SCI) will be tested.
DEVICE
Epidural stimulation
Currently implanted epidural stimulation will be used during diagnostic testing.
DEVICE
Transcutaneous stimulation
Transcutaneous stimulation will be used for participants with spinal cord injury without an implanted stimulator during diagnostic testing.
Primary outcome measures
Valsalva Maneuver Phase II
Time frame: During 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.
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
- 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
- Rochester, Minnesota
Related conditions & keywords
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 May 28, 2026 · Source of record for eligibility and locations