NCT02451371已完成1 期
A Pilot Study for the Treatment of Refractory Auditory Verbal Hallucinations With Transcranial Direct Current Stimulation(tDCS) in Patients With Schizophrenia
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Auditory hallucination change by changes in The Psychotic Symptom Rating Scales (PSYRATs) Auditory hallucinations subscale score
研究概览
简要总结
The purpose of this study is to exploratively evaluate the efficacy and safety of transcranial direct current stimulation (tDCS) in patients with schizophrenia who experience persistent auditory verbal hallucinations after adequate antipsychotics therapy for over three months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with schizophrenia by the Diagnostic and Statistical Manual of Mental Disorders, Fourth edition, Text Revision (DSM-IV-TR)
- •Presence of auditory hallucination after three months' trial of antipsychotics of adequate dose
- •The Hamilton Program for Schizophrenia Voices Questionnaire (HPSVQ) score is at least 8
排除标准
- •Significant brain pathology including head trauma, seizure, meningitis
- •Intellectual disability (IQ < 70)
- •Severe personality disorder
- •Substance use disorder (except nicotine)
- •Severe medical illness
- •Disability in the sensory organs
- •Pregnancy
结局指标
主要结局
Auditory hallucination change by changes in The Psychotic Symptom Rating Scales (PSYRATs) Auditory hallucinations subscale score
时间窗: approximately 2 weeks
Auditory hallucination change by changes in the auditory hallucinations subscale from the Psychotic Symptom Rating Scales
次要结局
- Electroencephalography - resting(approximately 2 weeks)
- Electroencephalography - P300 peak(approximately 2 weeks)
- Electroencephalography - P300 source(approximately 2 weeks)
- Electroencephalography - P50(approximately 2 weeks)
- Brain Magnetic Resonance Image (MRI) - T1 Image grey matter volume(approximately 2 weeks)
- Brain MRI - functional MRI(approximately 2 weeks)
- Brain MRI - Diffusion Tensor Image (DTI) functional anisotropy(approximately 2 weeks)
- Electroencephalography - ERN (error-related negativity) peak(approximately 2 weeks)
- Electroencephalography - ERN (error-related negativity) frequency activity(approximately 2 weeks)
- Brain Magnetic Resonance Image (MRI) - T1 Image grey matter thickness(approximately 2 weeks)
- Electroencephalography - ERN (error-related negativity) source(approximately 2 weeks)
- Brain MRI - Diffusion Tensor Image (DTI) mean diffusivity(approximately 2 weeks)
- Brain MRI - Diffusion Tensor Image (DTI) radial diffusivity(approximately 2 weeks)
- Brain MRI - Diffusion Tensor Image (DTI) axial diffusivity(approximately 2 weeks)
- Brain MRI - myelin image(approximately 2 weeks)
- Auditory hallucination change by changes in the Korean Version of Hamilton Program for Schizophrenia Voices Questionnaire (HPSVQ) score(approximately 2 weeks)
- Auditory hallucination change by changes in the Auditory Hallucination Rating Scale (AHRS) score(approximately 2 weeks)
- Kicer values change with treatment in striatum assessed by 18F-DOPA Positron Emission Tomography (PET)(approximately 2 weeks)
- Magnetic Resonance Spectroscopy (MRS)(approximately 2 weeks)
研究者
研究点 (2)
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