NCT06918964招募中2 期
Efficacy and Safety of Transcutaneous Auricular Vagus Nerve Stimulation for Acute Intracerebral Hemorrhage
Beijing Tiantan Hospital1 个研究点 分布在 1 个国家目标入组 186 人开始时间: 2025年9月15日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 186
- 试验地点
- 1
- 主要终点
- Volume of perihematoma edema assessed by CT
研究概览
简要总结
This study aims to evaluate the efficacy and safety of transcutaneous auricular vagus nerve stimulation (taVNS) in patients with acute intracerebral hemorrhage (ICH). The taVNS intervention will be delivered using the BS-TVNS800-1 transcutaneous electrical stimulation therapy device (KERFUN, Shanxi, China). A total of 186 patients will be randomly assigned in a 1:1 ratio to either the taVNS group or the sham-taVNS group. The primary outcome is the relative volume of perihematoma edema assessed on day 10-14 after randomization. Adverse events associated with taVNS therapy will be systematically evaluated to assess its safety profile.
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
- Double (Participant, Outcomes Assessor)
盲法说明
The participants and outcome assessors are unaware of the trial grouping.
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
- •Patients with spontaneous supratentorial intracerebral hemorrhage.
- •Age between 18 and 80 years.
- •Onset within 72 hours.
- •Hematoma volume between 5 and 40 mL.
- •Glasgow Coma Scale (GCS) score greater than
- •Written informed consent obtained from the patient or their legal representative.
排除标准
- •Secondary intracerebral hemorrhage (e.g., traumatic, tumor-related, vascular malformation, aneurysm, or coagulopathy-related).
- •Primary intraventricular hemorrhage.
- •Parenchymal hemorrhage that ruptures into the ventricles, with blood completely filling one lateral ventricle, the third ventricle, the fourth ventricle or more than half of both lateral ventricles.
- •Progressive neurological or other severe diseases.
- •Planned surgical treatment within 24 hours.
- •Pre-existing disability caused by previous illnesses: Modified Rankin Scale (mRS) score ≥
- •Patients with severe cardiomyopathy, heart failure, pacemaker implantation, atrial fibrillation, frequent premature beats, second-degree or higher atrioventricular block, or other severe arrhythmias.
- •Severe pulmonary disease, liver disease, renal insufficiency (glomerular filtration rate < 30 mL/min), active gastrointestinal bleeding, or malignant tumors with an expected survival of less than 3 months.
- •Patients with hyperthyroidism, hypothyroidism, syncope, epilepsy, multiple sclerosis, Parkinson's disease, multiple system atrophy, or other known disorders affecting autonomic nervous function.
- •Use of medications that interfere with autonomic function (e.g., beta-blockers, theophylline, tricyclic antidepressants, or steroids) within 7 days before screening.
- •Patients who cannot tolerate taVNS.
- •Congenital or acquired ear abnormalities preventing taVNS treatment.
- •Inability to comply with 10 days of treatment.
- •Pregnancy or within 30 days of delivery.
- •Participation in another interventional clinical trial.
- •Inability to obtain written informed consent from the participant or their legal representative.
结局指标
主要结局
Volume of perihematoma edema assessed by CT
时间窗: Day 10-14 after randomization
Relative edema volume.
次要结局
- Autonomic activity assessed by baroreflex sensitivity(Day 10-14 after randomization)
- National Institutes of Health stroke scale (NIHSS)(Day 10-14 after randomization)
- GCS (Glasgow Coma Scale)(Day 10-14 after randomization)
- MMSE (Mini-Mental State Examination)(Day 10-14 after randomization)
- MoCA (Montreal Cognitive Assessment)(Day 10-14 after randomization)
- 90-day modified Rankin Scale (mRS)(90 ± 7 days after randomization)
- 90-day EQ-5D (EuroQol 5-Dimension Questionnaire) score(90 ± 7 days after randomization)
- 90-day GCS (Glasgow Coma Scale)(90 ± 7 days after randomization)
- 90-day MMSE (Mini-Mental State Examination)(90 ± 7 days after randomization)
- PHQ-9 (Patient Health Questionnaire-9)(Day 10-14 after randomization)
- 90-day National Institutes of Health stroke scale (NIHSS)(90 ± 7 days after randomization)
- 90-day MoCA (Montreal Cognitive Assessment)(90 ± 7 days after randomization)
- 90-day PHQ-9 (Patient Health Questionnaire-9)(90 ± 7 days after randomization)
- Autonomic activity assessed by heart rate variability(Day 10-14 after randomization)
研究者
Kaijiang Kang
Principal Investigator
Beijing Tiantan Hospital
研究点 (1)
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