Deciphering Preserved Autonomic Function After Spinal Cord Injury

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-50
SponsorMayo Clinic

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

69 Participants
are divided into 2 treatment groups
Group A: Individuals with spinal cord injuryExperimental treatment 3 interventions
Group B: Individuals without spinal cord injuryExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Valsalva Maneuver Phase II

Presence or absence of phase II on Valsalva maneuver testing, which takes approximately 15 seconds to complete. This will be repeated x3.

Time frame
During laboratory diagnostic testing session

Secondary outcomes

1

Beat-to-beat heart rate

Electrocardiogram will record continuous measures with changes in R-R interval (ms) quantified and compared to baseline.

Time frame
During laboratory diagnostic testing session
2

Beat-to-beat blood pressure

Non-invasive continuous blood pressure monitors will be used, with changes in systolic and diastolic pressure (in mmHg) from resting baseline measured.

Time frame
During laboratory diagnostic testing session
3

Continuous galvanic skin response

Changes from resting state conductance with be quantified with a smartwatch.

Time frame
During laboratory diagnostic testing session
4

Continuous wrist temperature

Changes from resting state temperature with be quantified with a smartwatch.

Time frame
During laboratory diagnostic testing session

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.