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_TEST
    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.
  • Tests of sympathetic activation — DIAGNOSTIC_TEST
    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).
  • Testing of autonomic dysreflexia — DIAGNOSTIC_TEST
    Cold 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

Locations (1)

FacilityCityStateZIPSite coordinators
Mayo ClinicRochesterMinnesota55902
Erin Lund
507-284-9298

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