STORM: Safety, Feasibility, and Efficacy of Non-invasive Vagus Nerve Stimulation (nVNS) in the Treatment of Aneurysmal Subarachnoid Hemorrhage
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- The presentation of severe adverse device events (SADEs) within 30 minutes of nVNS first treatment dose.
研究概览
简要总结
This is a single-site, single-arm, open-label pilot study assessing the safety, feasibility, and efficacy of non-invasive vagus nerve stimulation (nVNS), gammaCore, for the acute treatment of aneurysmal subarachnoid hemorrhage (SAH) subjects in a neurocritical care setting. 25 patients will be enrolled, all treated with an active device. The primary efficacy outcomes are reduced aneurysm rupture rate, reduced seizure and seizure-spectrum activity, minimized hemorrhage grades, and increased survival.
详细描述
This is a single-site, single-arm, open-label pilot study assessing the safety, feasibility, and efficacy of non-invasive vagus nerve stimulation (nVNS), gammaCore, for the acute treatment of aneurysmal subarachnoid hemorrhage (SAH). The hypothesis is that two 2-minute non-invasive stimulations of the cervical branch of the vagus nerve with nVNS, 3 times daily (TID), is a safe, practical, and potentially effective treatment after SAH in the neurocritical care setting. After diagnosis and surgical repair of the SAH, patients admitted to the Neuroscience Intensive Care Unit (NeuroICU) at Massachusetts General Hospital (MGH) will be screened for eligibility. Upon providing informed consent, eligible patients will be enrolled, begin the treatment protocol, and will be monitored. Data collection will be completed using automated systems, electronic reports, and manual collection before, during, and after nVNS.
The primary objective is to examine the safety, feasibility, and possible efficacy of nVNS as a treatment after aneurysmal subarachnoid hemorrhage (SAH).
Safety will be assessed by the incidence of severe adverse device events (SADEs) following nVNS.
Feasibility of the nVNS implementation will be evaluated by the ability to deliver >85% of doses per protocol, report of minimal interference with current standard of care treatments and procedures in in the NeuroICU, and beginning of treatment within 72 hours of presumed aneurysm rupture.
Efficacy of nVNS will be explored using the following assessments:
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, 18-85 years of age
- •Ruptured aneurysmal SAH confirmed by angiography and repaired by neurosurgical clipping or endovascular occlusion (coiling)
- •Modified Glasgow Coma Scale (mGCS) score ≥ 10 and Hunt Hess 1-4 within 72 hours of presumed aneurysm rupture
- •Enrollment and initiation of nVNS treatment must occur within 72 hours of presumed aneurysm rupture
- •Provide a legally obtained informed consent form from the participant or the legally authorized representative (LAR); telephonic consent is acceptable
- •Female participants of reproductive age must have a negative pregnancy test result (urine or blood)
排除标准
- •Use of any concomitant electrostimulation device, including a pacemaker, defibrillator, or deep brain stimulator
- •No plan to secure aneurysm, defined as aneurysm that has not been surgically or endovascularly treated
- •Previous neck dissection or radiation
- •History of carotid artery disease or carotid surgery/dissection
- •History of secondary or tertiary heart blocks, ventricular tachycardia, or supraventricular tachycardia (SVT; including atrial fibrillation)
- •Screws, metals, or devices in the neck
- •Currently participating in an investigational drug or device clinical trial with potential to confound data collection
研究组 & 干预措施
Treatment group
The gammaCore device supplies non-invasive stimulation to the cervical branch of the vagus nerve.
干预措施: gammaCore (Device)
结局指标
主要结局
The presentation of severe adverse device events (SADEs) within 30 minutes of nVNS first treatment dose.
时间窗: up to 10 days post-rupture
The rate of serious adverse events, such as bradycardia, hypotension, and decline in modified Glasgow Coma Scale grade. Events are determined through continuous monitoring of vital signs, including but not limited to: blood pressure, O2 saturation, heart rate, routine blood work, EKG, and alarm trigger frequency.
次要结局
- The feasibility of nVNS in SAH subjects in the critical care setting.(up to 10 days post-rupture)
- The self-reported assessment for physical, mental, and social health at follow up (90 days).(at 90 days post-rupture)
- The occurrence of ischemic complications.(up to 10 days post-rupture)
- The frequency of alarm triggers peri-nVNS.(up to 10 days post-rupture)
- The measure of subject disability using a modified Rankin Score at baseline, intervention completion (10 days), and follow up (90 days).(at 10 days and 90 days post-rupture)
- The self-reported assessment for the quality of life of patients with neurological disorders at follow up (90 days).(at 90 days post-rupture)
- The rate of established predictors of delayed cerebral ischemia (DCI) and outcome.(up to 10 days post-rupture)
研究者
Aman B. Patel, M.D.
Associate Professor of Neurosurgery
Massachusetts General Hospital