Effect of tDCS on Cognition, Symptoms in Chronic Schizophrenia Patients With Tardive dyskinesia_a Randomized, Double-blind, Sham-controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- Abnormal Involuntary Movements Scale
研究概览
简要总结
The aim of the study was to evaluate the efficacy, safety, and cognitive function of transcranial direct current stimulation (tDCS) in chronic schizophrenia patients with tardive dyskinesia (TD).
详细描述
This study is a randomized, double-blind, sham-controlled clinical trial. 60 patients with TD were randomly allocated to active (n=30) or sham tDCS groups (n=30). All patients received 2-mA anodal left/cathodal right prefrontal tDCS treatment (fifteen 30-minutes sessions: Monday to Friday once daily, every other week to do a group of treatment). Abnormal Involuntary Movements Scale (AIMS), Tardive Dyskinesia Rating Scale (TDRS), Assessment of Negative Symptoms(SANS), the Positive and Negative symptom scale(PANSS), and the Cambridge Neuropsychological Test Automatic Battery (CANTAB) were assessed in patients. All evaluations were scored at baseline, the end of 3rd weeks, 5th weeks, and 7th weeks. Side effects of tDCS were assessed with an experimenter-administered open-ended questionnaire during the whole experiment.
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)
盲法说明
This study is a randomized, double-blind, sham-controlled clinical trial.All patients received 2-mA anodal left/cathodal right prefrontal tDCS treatment (fifteen 30-minutes sessions: Monday to Friday once daily, every other week to do a group of treatment). All evaluations were performed at baseline, the end of 3rd weeks, 5th weeks, and 7th weeks by 2 psychiatrists blinded to the treatment assigned. Inter-rater reliability was satisfactory(ka=0.86).
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Right-handed;
- •meeting the diagnosis of schizophrania;
- •had been receiving antipsychotic drugs for at least 12 months;
- •at least one AIMS item rated(moderate) or at least two AIMS items rated ≥2(mild);
- •All patients volunteered to participate in this study.
排除标准
- •organic disorder that could cause movement disorders, mental retardation,and a history of substance dependence(except nicotine);
- •with serious physical illness(e.g.severe cardiovascular diseases);
- •with color blindness/weakness, stuttering, deafness.
结局指标
主要结局
Abnormal Involuntary Movements Scale
时间窗: Change from baseline AIMS(items1-7) total scores at 3 weeks and 5 weeks and 7 weeks
The primary outcome measure was the severity of TD symptoms, which was measured by the AIMS total score(the sum of items 1-7).The range for subscale scores(items1-7) is between 0-28 scores and the higher values represent a worse outcome.
次要结局
- Positive and Negative symptom scale(Change from baseline PANSS total scores at 5 weeks)
- Scale for the Assessment of Negative Symptoms(Change from baseline SANS total scores at 5 weeks)
- Tardive Dyskinesia Rating Scale(Change from baseline TDRS total scores at 3 weeks and 5 weeks and 7 weeks)
- Safety and Tolerabilit(We assessed the side affects during and after tDCS.)
- Cambridge Neuropsychological Test Automatic Battery(Change from baseline cognitive function at 3 weeks and 5 weeks and 7 weeks)
研究者
Xiang-Dong Du
Associate Professor
Suzhou Psychiatric Hospital