Deciphering Preserved Autonomic Function After Spinal Cord Injury
Part of paid clinical trials in Rochester, Minnesota.
- Sponsor
- Mayo Clinic
- Study ID
- NCT04493372
- Status
- Recruiting
Conditions
- Autonomic Dysreflexia
- Autonomic Imbalance
- Orthostatic Hypotension
- Spinal Cord Injuries
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 50 Years
- Healthy Volunteers
- Accepted
Interventions
- Tests of sympathetic inhibition — DIAGNOSTIC_TESTBolus 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.
- Tests of sympathetic activation — DIAGNOSTIC_TESTCold 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).
- Testing of autonomic dysreflexia — DIAGNOSTIC_TESTCold pressor test of the foot and bladder pressor response (in individuals with SCI) will be tested.
Study Details
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.
Key Dates
- Start date
- Nov 13, 2020
- Status verified
- Apr 2026
- Primary completion
- Sep 8, 2026
- Completion
- Sep 8, 2026
Study Design
- Enrollment
- 69 participants (estimated)
- Allocation
- NON_RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- DIAGNOSTIC
Arms
- Experimental: Individuals with spinal cord injury
- Experimental: Individuals without spinal cord injury
Primary Outcome Measure
Valsalva Maneuver Phase II [ Time Frame: During laboratory diagnostic testing session ]
Central Contacts
- Erin Lund507-284-9298
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Mayo Clinic | Rochester | Minnesota | 55902 |
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