Safety and Efficacy of Non-invasive Vagus Nerve Stimulation in the Treatment of Headache in Subarachnoid Hemorrhage
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- The Difference Between the Active and Sham Treatment Groups in Morphine Equivalence Dosage PER DAY
研究概览
简要总结
This is a single site, randomized, sham-controlled, double blinded pilot study assessing the feasibility, safety, tolerability, and efficacy of non-invasive VNS (nVNS), gammaCore, in the treatment of headache in subarachnoid hemorrhage (SAH). 40 participants will be enrolled, 20 in the active device arm and 20 in the sham arm. The primary efficacy outcome is the the difference between the active and sham treatment groups in morphine equivalence dosage.
详细描述
This is a single site, randomized, sham-controlled, double-blind study assessing the feasibility, safety, tolerability, and efficacy of non-invasive VNS (nVNS) in the treatment of headache in subarachnoid hemorrhage (SAH). The hypothesis is that two-two minute noninvasive stimulations of the cervical branch of the Vagus nerve, every 5 hours, is efficacious in safely reducing headache intensity and frequency in patients with headache due to SAH, during the patient's intensive care unit (ICU) stay. After screening and obtaining informed consent, eligible patients diagnosed with SAH on head scans, admitted to the Neurosurgical Intensive Care Unit (NSCU) at Northshore University Hospital will be randomized to either the treatment (stimulation of the cervical branch of the Vagus nerve) or sham (inactive stimulation) group. Pain intensity will be evaluated every 4 hours. Non-invasive stimulation will be performed every 5 hours. Device related adverse events, mean headache intensity, and mean and peak morphine equivalence dosage during the study period will be compared between the VNS group and the sham group.
The primary objective of this study is to examine the safety and effectiveness of nVNS as a treatment for headache in subarachnoid hemorrhage (SAH).
The primary safety endpoint for this study is the incidence of device related serious adverse events.
The primary outcome measurements for effectiveness is the difference between the active and sham treatment groups in morphine equivalence dosage
Secondary endpoints include descriptive comparisons between the active and sham treatment groups in:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Established signed and dated informed consent form
- •CT of the head revealing blood in the subarachnoid space
- •Subject is male or female, 18 to 80 years of age
- •Subject alert to be able to verbalize pain level. If alertness improves after placement of an external ventricular drain, or once extubated, and the patient becomes alert , the patient will be enrolled
- •Subject reports pain of > =7 on 10 Point Pain numeric rating scale
- •Female of reproductive age must have a negative pregnancy test (Urine or blood test)
排除标准
- •Use of any concomitant electrostimulation devices (Pacemaker, defibrillator, deep brain stimulation.)
- •Unsecured aneurysm defined as aneurysm that has not been surgically or endovascularly treated.
- •Previous carotid surgeries or known history of carotid artery disease
- •Screws, metals or device in the neck
- •History of secondary or tertiary heart blocks, ventricular tachycardia, Supra-Ventricular Tachycardia (including atrial fibrillation)
- •Alcoholics (CAGE scale of 2 or greater). If patients are on Clinical Institute Withdrawal Assessment for Alcohol (CIWA) protocol for alcohol withdrawal, the patient will be excluded from the study.
- •Drug addicts or chronic opioid users confirmed by history or with urine toxicology showing opiates or cocaine
- •small traumatic SAH
结局指标
主要结局
The Difference Between the Active and Sham Treatment Groups in Morphine Equivalence Dosage PER DAY
时间窗: up to 14 days of admission
Daily morphine equivalence dosage will be calculated and compared between the active and Sham group
Overall Difference in MED at 7 Days
时间窗: baseline and 7 days
difference in mean morphine equivalent dosage at 7 days between active and sham group
次要结局
- The Difference in Device Related Heart Rate Change Before and After Stimulation(up to 14 days of admission)
- Change in SBP Between Active and Sham Group(before and after stimulation, up to 14 days)
- The Difference Between the Active and Sham Treatment Groups in the Mean Daily Headache Intensity Pre and Post Stimulation(up to 14 days of admission)
研究者
Tania Rebeiz
Assistant Professor, MD
Northwell Health