Auricular VNS Following Subarachnoid Hemorrhage

Официальное название

Transcutaneous Auricular Vagus Nerve Stimulation Following Spontaneous Subarachnoid Hemorrhage

Обзор

This study will evaluate whether non-invasive auricular vagal nerve stimulation lowers inflammatory markers, and improves outcomes following spontaneous subarachnoid hemorrhage.

Подробное описание

Vagal nerve stimulation (VNS) has been studied in several inflammatory conditions, and has been implemented in animal models of subarachnoid hemorrhage (SAH) with promising results. The purpose of the proposed study is to determine how applying auricular VNS in patients presenting with spontaneous SAH impacts their expression of inflammatory markers in their blood and cerebrospinal fluid (CSF), and how it impacts their clinical course and outcomes.

This study will involve randomizing patients to stimulation with VNS, or sham stimulation. Blood and CSF will be collected on admission, and serially throughout the patient's admission. Clinical events tracked during the hospital stay include development of cerebral vasospasm, need for CSF diversion via a shunt, stress-induced cardiomyopathy, and development of stroke or global cerebral ischemia. Outcomes following admission will include functional scores at discharge, and at follow-up visits for up to 2 years after discharge.

Вмешательства

• Устройство Auricular Vagus Nerve Stimulation
  Transcutaneous auricular vagal nerve stimulation
• Устройство Sham Auricular Vagus nerve Stimulation
  Transcutaneous auricular vagal nerve ear clip applied without current

Первичные конечные точки

• Inflammatory markers in the serum on admission [Срок оценки: On hospital day 1]
• Change in inflammatory markers in the serum [Срок оценки: Through hospital admission, average of 4 weeks]
• Inflammatory markers in the CSF on admission [Срок оценки: On hospital day 1]
• Change in inflammatory markers in the CSF [Срок оценки: Through hospital admission, average of 4 weeks]
• Cerebral vasospasm [Срок оценки: Through hospital admission, average of 4 weeks]
• Hydrocephalus [Срок оценки: Through hospital admission, average of 4 weeks]

Вторичные конечные точки (9)

• Inflammatory markers in the serum on admission [Срок оценки: On hospital day 1]
• Change in inflammatory markers in the serum [Срок оценки: Through hospital admission, average of 4 weeks]
• Inflammatory markers in the CSF on admission [Срок оценки: On hospital day 1]
• Change in inflammatory markers in the CSF [Срок оценки: Through hospital admission, average of 4 weeks]
• Cerebral vasospasm [Срок оценки: Through hospital admission, average of 4 weeks]
• Cerebral ischemia [Срок оценки: Through hospital admission, average of 4 weeks]
• Hydrocephalus [Срок оценки: Through hospital admission, average of 4 weeks]
• Clinical outcome [Срок оценки: 2 years]
• Stressed-induced cardiomyopathy [Срок оценки: Through hospital admission, average of 4 weeks]

Критерии участия

Критерии включения

• Spontaneous subarachnoid hemorrhage

Критерии исключения

• Trauma-induced subarachnoid hemorrhage
• Ongoing chemotherapy
• Taking immunosuppressive medications for other medical illnesses
• Presence of a pacemaker
• Prolonged bradycardia at time of admission

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Washington University School of Medicine — St Louis

Публикации

• Tan G, Huguenard AL, Donovan KM, Demarest P, Liu X, Li Z, Adamek M, Lavine K, Vellimana AK, Kummer TT, Osbun JW, Zipfel GJ, Brunner P, Leuthardt EC. The effect of transcutaneous auricular vagus nerve stimulation on cardiovascular function in subarachnoid hemorrhage patients: A randomized trial. Elife. 2025 Jan 9;13:RP100088. doi: 10.7554/eLife.100088. PMID 39786346
• Huguenard A, Tan G, Johnson G, Adamek M, Coxon A, Kummer T, Osbun J, Vellimana A, Limbrick D Jr, Zipfel G, Brunner P, Leuthardt E. Non-invasive Auricular Vagus nerve stimulation for Subarachnoid Hemorrhage (NAVSaH): Protocol for a prospective, triple-blinded, randomized controlled trial. PLoS One. 2024 Aug 23;19(8):e0301154. doi: 10.1371/journal.pone.0301154. eCollection 2024. PMID 39178291
• Huguenard AL, Tan G, Rivet DJ, Gao F, Johnson GW, Adamek M, Coxon AT, Kummer TT, Osbun JW, Vellimana AK, Limbrick DD, Zipfel GJ, Brunner P, Leuthardt EC. Auricular Vagus Nerve Stimulation Mitigates Inflammation and Vasospasm in Subarachnoid Hemorrhage: A Randomized Trial. medRxiv [Preprint]. 2024 May 1:2024.04.29.24306598. doi: 10.1101/2024.04.29.24306598. PMID 38746275
• Tan G, Huguenard AL, Donovan KM, Demarest P, Liu X, Li Z, Adamek M, Lavine K, Vellimana AK, Kummer TT, Osbun JW, Zipfel GJ, Brunner P, Leuthardt EC. The effect of transcutaneous auricular vagus nerve stimulation on cardiovascular function in subarachnoid hemorrhage patients: a safety study. medRxiv [Preprint]. 2024 Sep 8:2024.04.03.24304759. doi: 10.1101/2024.04.03.24304759. PMID 38633771
• Huguenard AL, Tan G, Johnson GW, Adamek M, Coxon AT, Kummer TT, Osbun JW, Vellimana AK, Limbrick DD Jr, Zipfel GJ, Brunner P, Leuthardt EC. Non-invasive Auricular Vagus nerve stimulation for Subarachnoid Hemorrhage (NAVSaH): Protocol for a prospective, triple-blinded, randomized controlled trial. medRxiv [Preprint]. 2024 Mar 19:2024.03.18.24304239. doi: 10.1101/2024.03.18.24304239. PMID 38562875

Идентификаторы

NCT: NCT04557618 · 202007034

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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