Dual-channel Transcranial Alternating Current Stimulations Targeting Negative Symptoms in Schizophrenia Patients: a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- reductive ratio of PANSS-negative symptoms scores
研究概览
简要总结
Negative symptoms are core symptoms in schizophrenia which play an important role in clinical outcomes and impede patients to return to society. Anti-psychotic medicines have shown limited effect in improving negative symptoms and cognitive functioning, whereas non-invasive neuromodulations, i.e. , transcranial alternating current stimulation (tACS), have shown promising potentials. Recently new evidence of brain structural and functional alterations has been provided by neuroimaging studies. Brady RO et al. found cerebellar-prefrontal network connectivity was related to negative symptoms in schizophrenia. It provides clues for developing a new tACS protocol targeting improving negative symptoms, in which dual-channel high-density alternating current stimulations were delivered over both the right dorsolateral prefrontal cortex and cerebellum simultaneously.
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
- Double (Participant, 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
- •meet the DSM-V diagnostic criteria for schizophrenia;
- •present with prominent negative symptoms with PANSS-negative scores >20, at least one score of PANSS N1-N7 >3, and reductive ratio of PANSS-negative in the past two weeks before recruitment <10%;
- •stable usage and dosage of anti-psychotic medicines in the past two weeks and during the tACS intervention.
- •age within 18-60;
- •illness duration >1year;
- •education at least 6 years;
- •written consent of receiving tACS intervention.
排除标准
- •Meet any DSM-V diagnostic criteria of any other psychiatric disorders besides schizophrenia ;
- •any history of alcohol or substance dependence in the past 3 months;
- •any other major physical disease (i.e., Sensorimotor disorder, neurological disease);
- •any metal implants or any other tACS contraindication.
结局指标
主要结局
reductive ratio of PANSS-negative symptoms scores
时间窗: At 1 week and 3 weeks
differences of reductive ratio of PANSS-negative symptoms scores after between active and sham tACS
次要结局
- changes of PANSS total scores(At 1 week and 3 weeks)
- cognitive functioning changes using MCCB(At 1 week and 3 weeks)
- changes of P300 activity(At 1 week)
- changes of MMN activity(At 1 week)
- changes of power of resting-state EEG activity(At 1 day and 1 week)
- centroid value from fNIRS recording before and after active or sham tACS(At 1 week)
- Integral value from fNIRS recording before and after active or sham tACS(At 1 week)