Acute and Chronic Repercussion of Spinal Cord Stimulation After Spinal Cord Injury

Обзор

The purpose of this research is to learn about how the participant's body is able to balance changes in blood pressure, and how spinal cord stimulation affects these changes as well as immune \& cardiovascular function in participants with spinal cord injury.

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 (in individuals with SCI) will be tested.
• Устройство Epidural stimulation
  Currently implanted epidural stimulation will be used during diagnostic testing.
• Устройство Transcutaneous stimulation
  Transcutaneous stimulation will be used for participants with spinal cord injury without an implanted stimulator during diagnostic testing.

Первичные конечные точки

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

Вторичные конечные точки (8)

• 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]

Критерии участия

Критерии включения

• Age 18-50.
• American Spinal Injury Association Impairment Scale A-D,64 to encompass a representational spectrum of autonomic dysfunction after spinal cord injury.
• Neurological level of injury, C6-T8, as defined by the International Standards for Neurological Classification of Spinal Cord Injury.64 Incorporating level of injury over this broad range to capture the spectrum of autonomic dysfunction. Individuals with injuries below T8 will not be included to ensure transcutaneous spinal cord stimulation does not occur over the injury/glial scar, where it may have altered properties. The C6 level was chosen to ensure hand cold pressor stimuli triggers above level sympathetic activation.
• Time since injury of greater than six months, given early changes in spinal cord connectivity and recovery prior to this.
• Both individuals with and without currently implanted epidural spinal cord stimulators will be enrolled.
• Twenty uninjured controls will also be enrolled.

Критерии исключения

• History of clinically diagnosed cardiovascular disease, diabetes, autonomic neuropathies, neurological disorders (with exception of spinal cord injury for individuals in those cohorts), or are active smokers.
• Individuals who are taking betablockers, antihypertensives, or other sympathetically active medications which they are unable to hold.
• Women who are pregnant or lactating, given known hormonal influences on autonomic regulation.65,66
• Cognitive issues preventing informed consent for participation.
• Body mass index >30 kg/m2 for the uninjured controls only given increased risk of prediabetes and potential confounding normative values.
• 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: Да

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, Tuthill C, Hamner JW, Taylor JA. Transcutaneous spinal cord stimulation and its impact on cardiovascular autonomic regulation after spinal cord injury. Am J Physiol Heart Circ Physiol. 2024 Jan 1;326(1):H116-H122. doi: 10.1152/ajpheart.00588.2023. Epub 2023 Nov 10. PMID 37947438
• Solinsky R, Burns K, Hamner JW, Veith DD, Singer W, Taylor JA. A Novel Testing Battery for Preserved Autonomic Regulation Following Spinal Cord Injury and New Translationally Focused Data Representation. Top Spinal Cord Inj Rehabil. 2025 Spring;31(2):50-61. doi: 10.46292/sci24-00071. Epub 2025 Jun 19. PMID 40585014

Идентификаторы

NCT: NCT07210411 · 25-001000

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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