Deciphering Preserved Autonomic Function After Spinal Cord Injury

NCT ID: NCT04493372

Last Updated: 2026-02-02

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 69 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-13
• Study Completion Date: 2026-03-31

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.

Detailed Description

This study looks to characterize gradients of dysfunction in the autonomic nervous system after spinal cord injury. To accomplish this, we are enrolling both individuals with and without spinal cord injuries (see inclusion criteria). Individuals will undergo the listed diagnostics as part of a battery of laboratory testing. These will be correlated to clinical histories of autonomic dysfunction the ADFSCI and COMPASS-31 surveys (noted in outcome measures).

Conditions

Spinal Cord Injuries; Autonomic Imbalance; Autonomic Dysreflexia; Orthostatic Hypotension

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Individuals with spinal cord injury

Group Type: EXPERIMENTAL

Tests of sympathetic inhibition

Intervention Type: 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

Intervention Type: 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

Intervention Type: DIAGNOSTIC_TEST

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

Individuals without spinal cord injury

Group Type: EXPERIMENTAL

Tests of sympathetic inhibition

Intervention Type: 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

Intervention Type: 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

Intervention Type: DIAGNOSTIC_TEST

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

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.

Intervention Type: 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).

Intervention Type: DIAGNOSTIC_TEST

Testing of autonomic dysreflexia

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

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Ryan J. Solinsky

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ryan Solinsky, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic

Rochester, Minnesota, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

PI

Role: CONTACT

solinsky.ryan@mayo.edu

507-255-4058

Facility Contacts

Ryan Solinsky, MD

Role: primary

Solinsky.Ryan@mayo.edu

Other Identifiers

23-005772

Identifier Type: -

Identifier Source: org_study_id