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

Mayo Clinic

Status: Enrolling

Conditions: Spinal Cord Injuries

Treatments: Diagnostic Test: Tests of sympathetic inhibition; Diagnostic Test: Testing of below level sympathetic activation; Diagnostic Test: Tests of above level sympathetic activation

Study type: Interventional

Funder types: Other

Identifiers

NCT07210437

25-003333

Details and patient eligibility

About

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.

Enrollment: 18 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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18 participants in 2 patient groups

Chronic Spinal Cord Injury

Experimental group

Treatment:

Diagnostic Test: Tests of above level sympathetic activation

Diagnostic Test: Testing of below level sympathetic activation

Diagnostic Test: Tests of sympathetic inhibition

Acute Spinal Cord Injury

Experimental group

Treatment:

Diagnostic Test: Tests of above level sympathetic activation

Diagnostic Test: Testing of below level sympathetic activation

Diagnostic Test: Tests of sympathetic inhibition