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NCT Number: NCT07210437

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

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.

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Key information

Conditions

Spinal Cord Injuries Central Nervous System Diseases Nervous System Diseases Spinal Cord Diseases Trauma, Nervous System Wounds and Injuries

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location status: Recruiting

Location contact

Erin Lund

CONTACT

[email protected]

507-284-9298

Ryan J. Solinsky, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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 above level 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 below level sympathetic activation

Diagnostic Test

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

Primary outcomes

  1. Valsalva Maneuver Phase II

    Time frame: During laboratory diagnostic testing session

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

Secondary outcomes

  1. Beat-to-beat heart rate

    Time frame: During laboratory diagnostic testing session

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

  2. Beat-to-beat blood pressure

    Time frame: During laboratory diagnostic testing session

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

  3. Continuous galvanic skin response

    Time frame: During laboratory diagnostic testing session

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

  4. Quantify autonomic dysreflexia and orthostatic hypotension

    Time frame: Baseline, prior to laboratory diagnostic testing session

    Participants will be given the Autonomic Dysfunction Following Spinal Cord Injury questionnaire (score range 0-436, with higher scores indicating more autonomic dysfunction).

  5. Respiration

    Time frame: During laboratory diagnostic testing session

    Elastic respiratory transducer bands around mid-chest and upper abdomen will monitor breathing depth and frequency.

  6. Beat-by-Beat Popliteal and Brachial Blood Flow

    Time frame: During laboratory diagnostic testing session

    The investigators will use Doppler derived flow velocities to estimate whole limb blood flow through the popliteal and brachial arteries

  7. Immunology Blood Draw

    Time frame: During laboratory diagnostic testing session

    Baseline samples will be collected and compared against changes to blood pressure.

  8. Serum Catecholamines and Cortisol

    Time frame: During laboratory diagnostic testing session

    Baseline resting catecholamines (norepinephrine, epinephrine, dopamine) and cortisol will be drawn from the IV after 10 minutes of quiet rest at baseline and prior to bladder filling or foot cold pressor. Just prior to the conclusion of this testing, an additional blood draw will take place through the IV to assess changes in these levels.

  9. Pressure-induced vasodilation

    Time frame: During laboratory diagnostic testing session

    Changes to skin blood flow following a gradual change in pressure to the skin surface area. Laser doppler will be used to monitor changes in blood flow.

Study contacts

Contact information is provided by the study sponsor or research team.

Erin Lund

CONTACT

[email protected]

507-284-9298

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • The Craig H. Neilsen Foundation

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Oct 7, 2025
Registry last updated
May 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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