Deciphering Preserved Autonomic Function After Multiple Sclerosis

Обзор

This study looks to characterize gradients of dysfunction in the autonomic nervous system in patients with clinically diagnosed multiple sclerosis. The autonomic nervous system plays key roles in regulation of blood pressure, skin blood flow, and bladder health- all issues that individuals with multiple sclerosis 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 multiple sclerosis 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 with multiple sclerosis will exhibit abnormalities in these precise metrics. The investigators will look to see if any substantial connections exist between different degrees of preserved autonomic function and secondary autonomic complications from multiple sclerosis. In accomplishing this, the investigators hope to give scientists important insights to how the autonomic nervous system works after multiple sclerosis and give physicians better tools to manage these secondary autonomic complications.

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 will be tested.

Первичные конечные точки

• Valsalva Maneuver Phase II [Срок оценки: During single laboratory diagnostic testing session, on average 30 minutes after start of laboratory testing session]

Вторичные конечные точки (7)

• Beat-to-beat heart rate [Срок оценки: Continuous recording during single laboratory diagnostic testing session, from baseline to lab session end, average of 3 hours in duration]
• Beat-to-beat blood pressure [Срок оценки: Continuous recording during single laboratory diagnostic testing session, from baseline to lab session end, average of 3 hours in duration]
• 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]
• Serum Catecholamines [Срок оценки: 3x during single laboratory diagnostic testing session - collected at Baseline, pre-pressor test, post-pressor test - pre-pressor & post-pressor timepoint labs collected on average 2.5 & 3 hours post-baseline, respectively]
• Serum Cortisol [Срок оценки: 3x during single laboratory diagnostic testing session - collected at Baseline, pre-pressor test, post-pressor test - pre-pressor & post-pressor timepoint labs collected on average 2.5 & 3 hours post-baseline, respectively]
• T-Cell Exhaustion Markers [Срок оценки: During single laboratory diagnostic testing session - Baseline]

Критерии участия

Критерии включения

• 18-50 years old
• clinically confirmed diagnosis of multiple sclerosis -OR- uninjured control

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
• having a body mass index (BMI) ≥ 35 kg/m2
• taking or being administered a medication known to potentially have adverse interactions with phenylephrine
• in the judgement of the principal investigator or clinical collaborator, 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

Идентификаторы

NCT: NCT07012135 · 24-007459

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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