Non-invasive TRanscutaneous Cervical Vagus Nerve Stimulation as a Treatment for Acute Stroke; Safety and Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 69
- 试验地点
- 8
- 主要终点
- Cardiovascular effects, clinical worsening or death (primary safety measure)
研究概览
简要总结
This study aims to determine safety and feasibility of non-invasive transcutaneous cervical Vagus nerve stimulation (nVNS) when delivered promptly after clinical diagnosis of acute stroke. Vagus nerve stimulation will be performed via GammaCore® device. A total of 60 patients will be randomized to each of 3 different groups; 'standard dose' vagal stimulation, 'high dose' vagal stimulation, and 'sham stimulation' (1:1:1 ratio). Adverse device events, serious adverse device events, and feasibility of vagal nerve stimulation at the setting of acute stroke will be evaluated. The study will be performed in a multi-center fashion among stroke centers within TurkStrokeNet Network.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
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
- •Male or female patients who are older than 18 years old who have been admitted to neurological intensive care or stroke units with ischemic or hemorrhagic stroke
- •Patients with symptom onset time within 6 hours or with unknown time of onset and no evidence of acute ischemia on fluid attenuation inversion recovery (FLAIR) imaging
- •Patients who have given written informed consent prior to undertaking any study-related procedure.
排除标准
- •Patients who have a pre-stroke disability ≥ 2 according to the modified Rankin Score
- •Patients who have a NIH Stroke Scale/Score (NIHSS) ≤ 4 or ≥30
- •Patients who have a NIHSS item 1a ≥2
- •Patients who have experienced early dramatic neurological improvement (NIHSS score improvement ≥8) prior to study randomization suggesting resolution of signs/symptoms of stroke
- •Patients with classical lacunar syndrome
- •Patients who have local infection, rash or space occupying lesion at the stimulation site
- •Patients with a prior injury to the vagus nerve (cervical vagotomy)
- •Patients with conditions that make the positioning of the device not possible such as tonic head deviation or involuntary movements of the head and neck
- •Patients using medications that can interfere with central neurotransmitter mechanisms potentially involved in the central vagal pathway (complete list is provided below under concomitant medications)
- •Patients with known severe (>90% stenosis) bilateral carotid artery disease
- •Patients with known carotid hypersensitivity
- •Patients who had undergone bilateral carotid endarterectomy or neck surgery involving the region of carotid triangle
- •Patients who have low blood pressure (Baseline SBP≤100 mmHg or DBP≤60 mmHg)
- •Patients who have slow heart rate (Baseline HR≤60/min)
- •Patients who have high blood pressure (SBP>220 mmHg or DBP>130 mmHg) despite initial line of treatment
- •Patients who have been involved in any investigational study within the previous 90 days
- •Patients who have any terminal illness such that the patient would not be expected to survive more than 90 days
- •Pregnant women
- •Patients with severe hypoglycemia at admission (<60 mg/dl)
- •Patient experiencing seizures
- •Patients with baseline ECG showing first-degree AV block; second- or third-degree atrio-ventricular block with no pacemaker/ICD in place; or ventricular tachycardia/fibrillation
- •Patients with digitalis toxicity
- •Patients who are suspected to have an acute coronary syndrome after clinical evaluations (Clinical, ECG, or any related biomarker)
- •Patients who are scheduled to have an emergent carotid artery angioplasty stenting or endarterectomy
- •Patients implanted with an electrical and/or neurostimulator device, including but not limited to cardiac pacemaker or defibrillator, vagal neurostimulator, deep brain stimulator, spinal stimulator, bone growth stimulator, or cochlear implant.
- •Patients implanted with metal cervical spine hardware or having a metallic implant near the GammaCore stimulation site.
结局指标
主要结局
Cardiovascular effects, clinical worsening or death (primary safety measure)
时间窗: 24 hours
any of the following: * severe bradycardia (HR ≤50/min) during treatment application * significant decrease in arterial blood pressure (≥20 mmHg decrease in mean arterial blood pressure) during treatment application * neurological worsening (progression of neurologic deficit as shown by ≥ 4 points increase in NIH Stroke Scale Score) within 24 hours * death within 24 hours
次要结局
未报告次要终点
研究者
Ethem Murat Arsava
Professor of Neurology
Hacettepe University