NCT01176721已完成2 期
Transcutaneous Non-invasive Vagus Nerve Stimulation (t-VNS) in the Treatment of Schizophrenia: a Randomized, Controlled, Double Blind, Two-armed Clinical Trial
cerbomed GmbH4 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2010年3月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 4
- 主要终点
- Safety and efficacy of t-VNS in schizophrenia
研究概览
简要总结
Randomized, controlled, double-blind, two-armed clinical investigation to show the efficacy and safety of transcutaneous vagus nerve stimulation (t-VNS), applied at the left auricle, in schizophrenia.
Study hypothesis: t-VNS may improve negative symptoms, depressive symptoms, cognitive impairment,and aggressive behavior of treated schizophrenia patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of a schizophrenic disorder (F20 according to ICD-10),duration of disease ≥ 12 months
- •Appliance of the t-VNS® medical device according to the manual
排除标准
- •Improvent of the PANSS score within the period of 2 - 4 weeks from screening to the baseline
- •Pregnancy
- •Bronchial asthhma in medical history
- •clinically relevant internistic, neurological or psychiatric diseases
- •abuse of drugs or alcohol until 4 weeks to enrollment
- •Traumatic brain injury in medical history as well as invasive and non-invasive methods of treatment (e.g. tumor surgery (Gammma knife surgery))
- •indication of structural impairment of the basal ganglia or the brain stem
- •malformations of the pinna
- •further circumstances that at the discretion of the investigator will not allow to include the subject into the clinical study
结局指标
主要结局
Safety and efficacy of t-VNS in schizophrenia
时间窗: 24 weeks
次要结局
- Recording of clinical performance of t-VNS in schizophrenia(24 weeks)
研究者
研究点 (4)
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