NCT02227563终止不适用
tDCS & Auditory Hallucinations in Schizophrenia (AVH-SZ)
Herzog Hospital2 个研究点 分布在 1 个国家目标入组 3 人开始时间: 2014年3月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 3
- 试验地点
- 2
- 主要终点
- change from baseline in auditory hallucination rating scale
研究概览
简要总结
The aim of this study is to evaluate tDCS effects on schizophrenia symptoms, particularly on auditory verbal hallucinations. tDCS applied with cathodal (inhibitory) electrode over the left temporal parietal junction and anodal (excitatory) electrode over the left dorsolateral prefrontal cortex.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ages 18-60
- •Primary diagnosis of Diagnostic and Statistical Manual, fifth edition, schizophrenia
- •Persistent auditory verbal hallucinations
- •Right handed
- •Under stable doses of antipsychotic medication for ≥4 weeks
- •Normal hearing by self-report and physical exam
- •Use of effective method of birth control for women of childbearing capacity
- •Capable to provide informed consent. For patients judged to be incapable to provide informed consent the legal guardian of the patient must agree to participation in the study and provide signed informed consent
排除标准
- •Current or past history of substance dependence or abuse (excluding nicotine)
- •Other current Axis I disorders
- •History of seizure, epilepsy in self or first degree relatives, stoke, brain surgery, head injury, intracranial metal implants, known structural brain lesion, devices that may be affected by tDCS (pacemaker, medication pump, cochlear implant, implanted brain stimulator)
- •Frequent and persistent migraines
- •History of adverse reaction to neurostimulation
- •Participation in study of investigational medication within 6 weeks
- •Pregnancy
- •Women who are breast-feeding
- •Current significant laboratory abnormality
结局指标
主要结局
change from baseline in auditory hallucination rating scale
时间窗: 1 week post-treatment
次要结局
- change in self-report quality of life scale from baseline(1 week post treatment)
研究者
研究点 (2)
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