Recruiting

Observational Study

Sponsor:

Mayo Clinic

Code:

NCT04493372

Conditions

Spinal Cord Injuries

Autonomic Imbalance

Autonomic Dysreflexia

Orthostatic Hypotension

Eligibility Criteria

Sex: All

Age: 18 - 50

Healthy Volunteers: Accepted

Interventions

Tests of sympathetic inhibition

Tests of sympathetic activation

Testing of autonomic dysreflexia

Study Details

Brief summary:

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.

Conditions

Spinal Cord Injuries

Autonomic Imbalance

Autonomic Dysreflexia

Orthostatic Hypotension

Study ID

NCT04493372

Start date

Nov 13, 2020

Status verified date

Apr, 2026

Completion date

Sep 8, 2026

Anticipated

Primary completion date

Sep 8, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 50

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

69 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Individuals with spinal cord injury

experimental: Individuals without spinal cord injury

Interventions

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.

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).

Testing of autonomic dysreflexia

Cold pressor test of the foot and bladder pressor response (in individuals with SCI) will be tested.

Primary outcome measure

  • Valsalva Maneuver Phase II [ Time Frame: During laboratory diagnostic testing session ]

Central Contacts and Locations

Central contacts

Locations

Mayo Clinic

Recruiting

Rochester, Minnesota, United States, 55902

Contacts

More Information

Sponsor

Mayo Clinic

Last update posted

May 28, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-05-28.