NCT04493372 · Mayo Clinic
Deciphering Preserved Autonomic Function After Spinal Cord Injury
What this study is about
This study looks to characterize gradients of dysfunction in the autonomic nervous system after spinal cord injury. The autonomic nervous system plays key roles in regulation of blood pressure, skin blood flow, and bladder health- all issues that individuals with spinal cord injury typically suffer.
View original scientific description
This study looks to characterize gradients of dysfunction in the autonomic nervous system after spinal cord injury. The autonomic nervous system plays key roles in regulation of blood pressure, skin blood flow, and bladder health- all issues that individuals with spinal cord injury typically suffer. Focusing on blood pressure regulation, the most precise metric with broad clinical applicability, the investigators will perform laboratory-based tests to probe the body's ability to generate autonomic responses. For both individuals with spinal cord injury and uninjured controls, laboratory-based experiments will utilize multiple parallel recordings to identify how the autonomic nervous system is able to inhibit and activate signals. The investigators anticipate that those with autonomic dysfunction after spinal cord injury will exhibit abnormalities in these precise metrics. The investigators will further have research participants wear a smart watch that tracks skin electrical conductance, heart rate, and skin temperature, which can all provide clues as to the degree of autonomic dysfunction someone may suffer at home. The investigators will look to see if any substantial connections exist between different degrees of preserved autonomic function and secondary autonomic complications from spinal cord injury. In accomplishing this, the investigators hope to give scientists important insights to how the autonomic nervous system works after spinal cord injury and give physicians better tools to manage these secondary autonomic complications.
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 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 autonomic dysreflexia
Cold pressor test of the foot and bladder pressor response (in individuals with SCI) will be tested.
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
- All subjects \- age 18-50 years old. Participants with spinal cord injury
- Adult onset, traumatic spinal cord injury.
- American Spinal Injury Association Impairment Scale, A-D, to encompass a spectrum of autonomic dysfunction after spinal cord injury.
- Neurological level of injury, C1-T12, as defined by the International Standards for Neurological Classification of Spinal Cord Injury. Incorporating level of injury down to T12 to encompass a broad range of autonomic dysfunction.
Exclusion criteria
- History of cardiovascular disease, hypertension, neurologic disorders (with exception of spinal cord injury), or diabetes.
- Women who are pregnant or lactating.
- Currently taking blood thinners.
- Pacemaker, implanted defibrillator, or intrathecal pump incompatible with MRI scanning.
- Cognitive issues preventing informed consent for participation.
- Body mass index \>30 kg/m2 for controls, in an effort to limit effects of early cardiovascular disease and diabetes in control population. Body mass index has not proven to be a good estimate of these factors following spinal cord injury.
Where
- Rochester, Minnesota
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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