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

Обзор

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.

Вмешательства

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

Первичные конечные точки

• Valsalva Maneuver Phase II [Срок оценки: During laboratory diagnostic testing session]

Вторичные конечные точки (9)

• Beat-to-beat heart rate [Срок оценки: During laboratory diagnostic testing session]
• Beat-to-beat blood pressure [Срок оценки: During laboratory diagnostic testing session]
• Continuous galvanic skin response [Срок оценки: During laboratory diagnostic testing session]
• Quantify autonomic dysreflexia and orthostatic hypotension [Срок оценки: Baseline, prior to laboratory diagnostic testing session]
• Respiration [Срок оценки: During laboratory diagnostic testing session]
• Beat-by-Beat Popliteal and Brachial Blood Flow [Срок оценки: During laboratory diagnostic testing session]
• Immunology Blood Draw [Срок оценки: During laboratory diagnostic testing session]
• Serum Catecholamines and Cortisol [Срок оценки: During laboratory diagnostic testing session]
• Pressure-induced vasodilation [Срок оценки: During laboratory diagnostic testing session]

Критерии участия

Критерии включения

• 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).

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Диагностика

Центры проведения

США · 1 центр

• Mayo Clinic — Rochester

Публикации

• 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

Идентификаторы

NCT: NCT07210437 · 25-003333

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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