Vagus Nerve Stimulation Following Intracerebral Hemorrhage (IHC) to Mitigate ICH-induced Inflammation and Cerebral Edema
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Change in the inflammatory marker IL-6 in plasma
研究概览
简要总结
This study will evaluate whether non-invasive auricular vagal nerve stimulation lowers inflammatory markers, and improves outcomes following intracerebral hemorrhage.
详细描述
Vagal nerve stimulation (VNS) has been studied as a novel method of reducing inflammation, and it has been successfully used in animal models of inflammatory conditions. The purpose of the proposed study is to determine if transcutaneous auricular VNS will impact inflammatory markers in the blood and cerebrospinal fluid (CSF) in patients with intracerebral hemorrhage, 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 the development of peri-hematomal edema, interventions for edema (medical or surgical), and intensive care unit and hospital stay. Outcomes following admission will include functional scores at discharge, and at follow-up visits for up to 2 years after discharge. No additional appointments will be made specially for the research study.
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)
盲法说明
All participants will be fitted with an auricular stimulator, but blinded to whether they are receiving stimulation or not. Outcome scores will be assessed and recorded by clinicians blinded to treatment arm.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients who present with a spontaneous supratentorial intracerebral hemorrhage (ICH) to Barnes Jewish Hospital
排除标准
- •Patients < 18 years old
- •Patients with a presumed traumatic etiology for their ICH, infratentorial location, ICH volume > 60 ml or < 10 ml, at risk of imminent death (e.g. Glasgow Coma Scale, GCS of 3 or one or more pupils unreactive), surgical intervention imminently planned (not including ventriculostomy)
- •Patients undergoing active cancer therapy
- •Patients with sustained bradycardia on arrival with a heart rate < 50 beats per minute.
- •Patients who cannot be enrolled within 48 hours of the initial bleed.
研究组 & 干预措施
Auricular VNS Stimulation
Participants receive twice daily auricular vagal nerve stimulation
干预措施: Auricular Vagus Nerve Stimulation (Device)
Sham Auricular VNS Stimulation
Participants will have an auricular vagal nerve stimulator placed in their ear twice daily, without the stimulation applied
干预措施: Sham Auricular Vagus nerve Stimulation (Device)
结局指标
主要结局
Change in the inflammatory marker IL-6 in plasma
时间窗: 14 days
Blood samples collected on days 1, 4, 7, 10, and 14 (Day 1 serves as baseline, prior to first treatment). Inflammatory markers will be reported in pg/mL.
Growth of perihematomal edema
时间窗: 14 days
Change in edema extension distance (baseline vs. peak) will be compared between groups, via quantitative assessment of serial computed tomography (CT) scans obtained on day 1, 4, 7, 10, and 14 (Day 1 serves as baseline, prior to first treatment).
Neurological worsening
时间窗: Through hospital admission, average 14 days
Occurrence of clinical deterioration due to edema by criteria of 1) a reduction in GCS by 2 points or greater that persists for at least one hour, 2) worsening focal neurological deficits (NIHSS increase by at least 4 points), excluding other causes, or 3) need for surgical intervention or medical treatments for edema (osmotic therapies).
次要结局
- Change in additional inflammatory markers in plasma(14 days)
- Change in inflammatory markers in cerebrospinal fluid(14 days)
- Neurological outcome(2 years)
- Hospital length of stay(Through hospital admission, average 14 days)
- Relative perihematomal edema(14 days)