Longitudinal Autonomic Characterization as a Predictor for Secondary Medical Complications Post-SCI

NCT ID: NCT07210437

Last Updated: 2025-12-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-02-01
• Study Completion Date: 2028-06-01

Brief Summary

The purpose of this research is to learn about how the body is able to balance changes in blood pressure, how that changes over time, and how these changes impact a participant's risk of developing medical problems.

Conditions

Spinal Cord Injuries

Study Design

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

Study Groups

Chronic 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 above level 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 below level sympathetic activation

Intervention Type: DIAGNOSTIC_TEST

Cold pressor test of the foot and bladder pressor response will be tested.

Acute 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 above level 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 below level sympathetic activation

Intervention Type: DIAGNOSTIC_TEST

Cold pressor test of the foot and bladder pressor response 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 above level 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 below level sympathetic activation

Cold pressor test of the foot and bladder pressor response will be tested.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• 18-75 years old
• Spinal cord injury with neurological level of injury from C6-T12
• ASIA Impairment Scale A-D.
• Either acute SCI <3 months prior (n=10) or chronic SCI (>1 year since injury, n=8).

Exclusion Criteria

• Symptoms of cardiovascular (including, but not limited to: hypertension, stroke, chest pain, etc.), respiratory, peripheral neurological or autonomic disease (particularly diabetes mellitus requiring treatment);
• Women who are pregnant or lactating
• Taking or being administered a medication known to potentially have adverse interactions with phenylephrine
• In the judgement of the principal investigator, any illness or condition that will interfere with the patient's ability to comply with the protocol, compromise patient safety, or interfere with the interpretation of the study results.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Craig H. Neilsen Foundation

OTHER

Sponsor Role: collaborator

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

Zachary Pohlkamp

Role: CONTACT

pohlkamp.zachary@mayo.edu

507-422-0140

Facility Contacts

Zachary Pohlkamp

Role: primary

507-422-0140

References

Solinsky R, Burns K, Hamner JW, Singer W, Taylor JA. Characterizing preserved autonomic regulation following spinal cord injury: Methods of a novel concerted testing battery and illustrative examples of a new translationally focused data representation. medRxiv [Preprint]. 2024 Jun 1:2024.05.31.24308290. doi: 10.1101/2024.05.31.24308290.

Reference Type: BACKGROUND

PMID: 38854077 (View on PubMed)

Other Identifiers

25-003333

Identifier Type: -

Identifier Source: org_study_id