Clinical Trials for Neuroimaging and Electrophysiology in Schizophrenic Patients With Negative Symptoms Using Transcranial Direct Current Stimulation
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- Positive and Negative Syndrome Scale (PANSS)
研究概览
简要总结
The investigators conducted a randomized controlled trial to reveal the effect of tDCS on negative symptoms in patients with schizophrenia and its underlying mechanism using the neuroimaging and electrophysiology.
详细描述
The project will investigate the use of a novel technique, transcranial direct current stimulation (tDCS) in the treatment of patients with schizophrenia. tDCS permit the application of an extremely weak continuous electrical current to the brain through an anode and a cathode applied on the scalp. Anodal stimulation appears to increase brain activity whereas cathodal stimulation has the opposite effect.
Using anodal and cathodal tDCS the investigators aimed to treat negative symptoms of schizophrenia. The investigators plan to apply tDCS such that it can simultaneously increased activity in the frontal brain areas and reduce activity over temporoparietal cortex, 2 areas involved in the physiopathology of the disease. Real active stimulation will be compare to a sham condition in 44 patients (22 in each group). 44 patients will be included in Seoul National University Hospital
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)
盲法说明
All researchers will conduct research with only the encrypted subject number. A separate third-party researcher will participate to encrypt the subject and adjust the active/sham direction of the tDCS device during the actual research.
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •DSM-IV Schizophrenia
- •1 or more items of Negative symptom score in PANSS > 5
排除标准
- •presences of neurological disorder or history
- •presence of severe personality disorders
- •presence of substance use disorder (except nicotin)
- •pregnancy
- •presence of severe medical condition or disorders
研究组 & 干预措施
actual tDCS
2mA direct current, 20 minutes per session, 2 sessions per day with at least 3hours interval between sessions, a total of 10 tDCS sessions
干预措施: tDCS (Device)
sham tDCS
sham direct current, 20 minutes per session, 2 sessions per day with at least 3hours interval between sessions, a total of 10 tDCS sessions
干预措施: tDCS (Device)
结局指标
主要结局
Positive and Negative Syndrome Scale (PANSS)
时间窗: approximately 2 weeks (baseline and 2 weeks followups)
changes in psychopathology To assess a patient using PANSS, an approximately 45-minute clinical interview is conducted. The patient is rated from 1 to 7 on 30 different symptoms based on the interview as well as reports of family members or primary care hospital workers
次要结局
- The Clinical Assessment Interview for Negative Symptoms (CAINS)(approximately 2 weeks (baseline and 2 weeks followups))
- DTI - radial diffusivity (RD)(approximately 2 weeks (baseline and 2 weeks followups))
- DTI - fractional anisotropy (FA)(approximately 2 weeks (baseline and 2 weeks followups))
- MRI - MRS(approximately 2 weeks (baseline and 2 weeks followups))
- Letter/Category fluency test(approximately 2 weeks (baseline and 2 weeks followups))
- MRI - cortical thickness(approximately 2 weeks (baseline and 2 weeks followups))
- MRI - cortical gyrification(approximately 2 weeks (baseline and 2 weeks followups))
- Electroencephalography - MMN(approximately 2 weeks (baseline and 2 weeks followups))
- Electroencephalography - ERN(approximately 2 weeks (baseline and 2 weeks followups))
- MRI - cortical surface area(approximately 2 weeks (baseline and 2 weeks followups))
- DTI - axial diffusivity (AD)(approximately 2 weeks (baseline and 2 weeks followups))
- Electroencephalography - P300(approximately 2 weeks (baseline and 2 weeks followups))
- MRI - grey matter volume(approximately 2 weeks (baseline and 2 weeks followups))
- Korean Wechsler Adult Intelligence Scale (K-WAIS)(baseline)
- Spatial Working Memory(approximately 2 weeks (baseline and 2 weeks followups))
- California Verbal Learning Test(approximately 2 weeks (baseline and 2 weeks followups))
- Electroencephalography - resting(approximately 2 weeks (baseline and 2 weeks followups))
- DTI - mean diffusivity (MD)(approximately 2 weeks (baseline and 2 weeks followups))
- MRI - rsfMRI(approximately 2 weeks (baseline and 2 weeks followups))
- fNIRS(approximately 2 weeks (baseline and 2 weeks followups))
研究者
Tae Young Lee, MD
Research Professor
Seoul National University Hospital