Deciphering Preserved Autonomic Function After Spinal Cord Injury

Обзор

This study looks to characterize gradients of dysfunction in the autonomic nervous system after spinal cord injury. The autonomic nervous system plays key roles in regulation of blood pressure, skin blood flow, and bladder health- all issues that individuals with spinal cord injury typically suffer. Focusing on blood pressure regulation, the most precise metric with broad clinical applicability, the investigators will perform laboratory-based tests to probe the body's ability to generate autonomic responses. For both individuals with spinal cord injury and uninjured controls, laboratory-based experiments will utilize multiple parallel recordings to identify how the autonomic nervous system is able to inhibit and activate signals. The investigators anticipate that those with autonomic dysfunction after spinal cord injury will exhibit abnormalities in these precise metrics. The investigators will further have research participants wear a smart watch that tracks skin electrical conductance, heart rate, and skin temperature, which can all provide clues as to the degree of autonomic dysfunction someone may suffer at home. The investigators will look to see if any substantial connections exist between different degrees of preserved autonomic function and secondary autonomic complications from spinal cord injury. In accomplishing this, the investigators hope to give scientists important insights to how the autonomic nervous system works after spinal cord injury and give physicians better tools to manage these secondary autonomic complications.

Подробное описание

This study looks to characterize gradients of dysfunction in the autonomic nervous system after spinal cord injury. To accomplish this, we are enrolling both individuals with and without spinal cord injuries (see inclusion criteria). Individuals will undergo the listed diagnostics as part of a battery of laboratory testing. These will be correlated to clinical histories of autonomic dysfunction the ADFSCI and COMPASS-31 surveys (noted in outcome measures).

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 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 autonomic dysreflexia
  Cold pressor test of the foot and bladder pressor response (in individuals with SCI) will be tested.

Первичные конечные точки

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

Вторичные конечные точки (6)

• 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]
• Continuous wrist temperature [Срок оценки: During laboratory diagnostic testing session]
• Quantify autonomic dysreflexia and orthostatic hypotension [Срок оценки: Baseline, prior to laboratory diagnostic testing session]
• Quantify secondary autonomic complications [Срок оценки: Baseline, prior to laboratory diagnostic testing session]

Критерии участия

Критерии включения

All subjects

\- age 18-50 years old.

Participants with spinal cord injury

• Adult onset, traumatic spinal cord injury.
• American Spinal Injury Association Impairment Scale, A-D, to encompass a spectrum of autonomic dysfunction after spinal cord injury.
• Neurological level of injury, C1-T12, as defined by the International Standards for Neurological Classification of Spinal Cord Injury. Incorporating level of injury down to T12 to encompass a broad range of autonomic dysfunction.

Критерии исключения

• History of cardiovascular disease, hypertension, neurologic disorders (with exception of spinal cord injury), or diabetes.
• Women who are pregnant or lactating.
• Currently taking blood thinners.
• Pacemaker, implanted defibrillator, or intrathecal pump incompatible with MRI scanning.
• Cognitive issues preventing informed consent for participation.
• Body mass index >30 kg/m2 for controls, in an effort to limit effects of early cardiovascular disease and diabetes in control population. Body mass index has not proven to be a good estimate of these factors following spinal cord injury.

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Диагностика

Центры проведения

США · 1 центр

• Mayo Clinic — Rochester

Идентификаторы

NCT: NCT04493372 · 23-005772

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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