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Recruiting NCT07210437

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

No phase Interventional Spinal Cord Injuries

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Tests of sympathetic inhibition, Tests of above level sympathetic activation, Testing of below level sympathetic activation.
Who it may be relevant to
Registry conditions: Spinal Cord Injuries. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Diagnostic test 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.
  • 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).
  • Diagnostic test Testing of below level sympathetic activation
    Cold pressor test of the foot and bladder pressor response will be tested.

Primary outcome measures

  • Valsalva Maneuver Phase II [Time frame: During laboratory diagnostic testing session]
Secondary outcome measures (9)
  • Beat-to-beat heart rate [Time frame: During laboratory diagnostic testing session]
  • Beat-to-beat blood pressure [Time frame: During laboratory diagnostic testing session]
  • Continuous galvanic skin response [Time frame: During laboratory diagnostic testing session]
  • Quantify autonomic dysreflexia and orthostatic hypotension [Time frame: Baseline, prior to laboratory diagnostic testing session]
  • Respiration [Time frame: During laboratory diagnostic testing session]
  • Beat-by-Beat Popliteal and Brachial Blood Flow [Time frame: During laboratory diagnostic testing session]
  • Immunology Blood Draw [Time frame: During laboratory diagnostic testing session]
  • Serum Catecholamines and Cortisol [Time frame: During laboratory diagnostic testing session]
  • Pressure-induced vasodilation [Time frame: During laboratory diagnostic testing session]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Diagnostic

Study locations

United States · 1 center
  • Mayo Clinic — Rochester

Publications

  • 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. PMID 38854077

Identifiers

NCT: NCT07210437 · 25-003333

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗