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临床试验/NCT07131696
NCT07131696招募中不适用

The Effect of Transcutaneous Vagal Nerve Stimulation (tVNS) on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid Hemorrhage

Marshall Holland1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2026年2月6日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
10
试验地点
1
主要终点
Number of participants affected by cerebral inflammation during the course of the study as assessed by laboratory markers in blood and cerebral spinal fluid

研究概览

简要总结

The significance of developing a safe and effective therapy for aneurysmal subarachnoid hemorrhage (aSAH) patients suffering cerebral vasospasm (CVS) cannot be overstated. Vasospasm - a clamping down of normal arteries in the days following rupture - remains incredibly challenging to treat.1,2 Current drugs and minimally invasive surgical therapies are helpful, yet woefully insufficient. Symptomatic cerebral vasospasm afflicts about 30% of aneurysmal subarachnoid hemorrhage patients and nearly half will go on to suffer a stroke, despite aggressive medical care.1-3 The autonomic nervous system is a balance between sympathetic (fight or flight) and parasympathetic (rest and digest) influence with sympathetic overactivity and inflammation shown to play an important role in the development and severity of cerebral vasospasm.4,5,17-20 Prior studies of autonomic nervous system neuromodulation highlight its promise as a promising potential avenue to improve morbidity and mortality from CVS in aSAH.6-15 Despite progress, continued high levels of CVS morbidity and mortality stress the urgent need for exploration of neuromodulation therapy.

In this proposal, the study team will modulate the autonomic nervous system function in aSAH patients using transcutaneous vagal nerve stimulation (tVNS). tVNS involves placement of a stimulation electrode on the external ear to non-invasively stimulate a branch of the vagal nerve and increase parasympathetic influence. This device has FDA approval for epilepsy and cluster headache.

The study hypothesis is that neuromodulation of the autonomic nervous system with tVNS (increasing parasympathetic influence) reduces sympathetic overactivity and inflammation in aSAH resulting in decreased morbidity of CVS.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Provision of signed and dated informed consent
  • •Stated willingness to comply with all study procedures and availability for the duration of the study
  • •Male or Female
  • •18-65 years of age
  • •Diagnosed with Fisher grade 3 or 4 aneurysmal subarachnoid hemorrhage
  • •Ability to undergo endovascular treatment of aneurysmal subarachnoid hemorrhage
  • •For females of reproductive potential: negative pregnancy test at time of treatment.
  • •Plan to undergo standard of care treatment and follow-up

排除标准

  • •Medically unfit to undergo endovascular treatment (e.g., Hunt Hess grade 5)
  • •Does not provide consent
  • •Posterior circulation aneurysmal subarachnoid hemorrhage
  • •Initial aneurysm treatment after post bleed day 1

研究组 & 干预措施

tVNS

Experimental

干预措施: Transcutaneous Vagal Nerve Stimulation (Device)

结局指标

主要结局

Number of participants affected by cerebral inflammation during the course of the study as assessed by laboratory markers in blood and cerebral spinal fluid

时间窗: Pre-op, Day 1, 2, 7, 10, and discharge (assessed up to 21 days)

Rate of blood flowing through the brain as assessed by transcranial doppler imaging

时间窗: Pre-op, Day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, and discharge (assessed up to 21 days)

Number of participants experiencing sudden health issues during the study as determined by the need for ventriculoperitoneal shunt placement prior to discharge, length of hospital stay, and disposition upon discharge.

时间窗: Pre-op, Day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, and discharge (assessed up to 21 days)

次要结局

未报告次要终点

研究者

发起方
Marshall Holland
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Marshall Holland

Assistant Professor of Neurosurgery

University of Alabama at Birmingham

研究点 (1)

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