Efficacy of tDCS in the Treatment of Resistant Auditory Hallucinations in Schizophrenia: A Double Blind, Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 3
- 主要终点
- auditory hallucinations rating scale (AHRS)
研究概览
简要总结
The regions which are assumed to underlie the pathophysiology of schizophrenia, namely hypoactivity at the prefrontal level and pathological hyperactivity of the associative regions of the language located in the left temporoparietal region.
To assess the efficacy of tDCS on auditory hallucinations, the investigators performs an randomized double blind versus placebo trial. In each arms patients will receive two tDCS sessions a day during two weeks.
详细描述
Hearing hallucinations are one of the major symptoms of schizophrenia. In 30% of patients they are resistant to common psychotropic treatments. tDCS (Transcranial Direct Current Stimulation) is a technical of brain stimulation, non-invasive, painless that modulates brain activity by the transcranial administration of a low-intensity electric current, via two electrodes (an anode and a cathode). Several scientifics studies have reported a beneficial effect of tDCS in the treatment of pain, depression and especially hearing hallucinations in schizophrenia.
The main study purpose is to evaluate the effectiveness of tDCS on resistant auditory hallucinations in patients with schizophrenia.
Then, to evaluate the effectiveness of tDCS on global schizophrenic symptomatology and to assess the impact of tDCS on patients' quality of life.
Also the study, evaluate the impact of tDCS on cortical excitability. We measure the change in serum BDNF (Brain Derived Neutrophic Factor) before and after tDCS stimulation. Indeed, to evaluate the impact of tDCS on neurocognitive functions.
Patients will receive either active tDCS or placebo tDCS randomly. All patients will have two tDCS/day sessions, one hour apart, for 2 working weeks. The stimulation parameters will be consistent with the literature data, namely: Intensity = 2mA; duration of sessions = 20 minutes; total number of sessions = 20 (2 daily sessions for two working weeks).
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Schizophrenia according to DSM-V.
- •Refractory auditory hallucinations(despite two antipsychotics trials).
- •Right-handed patients.
- •Written informed consent.
排除标准
- •Presence of other psychiatric disorders than schizophrenia (except addiction to tobacco or caffeine ).
- •History of severe head trauma or coma.
- •History of epilepsy or neurological disorder or a general medical condition.
- •Presence of intracranial metallic objects or pacemaker.
- •Hospitalized patients without consent.
- •pregnant women .
研究组 & 干预措施
transcranial direct current stimulation
The transcranial direct current stimulation (tDCS) with two elecrodes placed over the scalp: the anode over the LTP, le cathode over L DLPFG.
干预措施: transcranial direct current stimulation (Device)
transcranial direct current stimulation sham
tDCS device allows sham stimulation. This technic give the same impression that active stimulation and allows optimum placebo stimulation.
干预措施: transcranial direct current stimulation (Device)
结局指标
主要结局
auditory hallucinations rating scale (AHRS)
时间窗: 15 days after
AHRS is a scale frequently used to assess auditory hallucinations in schizophrenia studies (Hoffman et al. 2005).
次要结局
- CGI(15 days after)
- PANSS,(15 days after)
研究者
Noomane Bouaziz, MD
MD
Centre hospitalier de Ville-Evrard, France