Efficacy of high definition transcranial direct current stimulation in negative symptoms of Schizophrenia as measured by proton magnetic resonance spectroscopy - a randomised sham controlled study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Primary outcome of the study is change in negative symptoms score as assessed at the end of 2 weeks of HDtDCS treatment with the specially designed score sheet.
研究概览
简要总结
Negative symptoms are highly relevant in the long course of schizophrenia. Antipsychotic drugs have been only mildly effective in improving negative symptoms. Negative symptoms are consistently related to specific neuroanatomical correlates, especially the prefrontal cortex. Promising results have been obtained in the study of effect of tDCS on negative symptoms. The study aims at assessing the effect of High Definition trancranial Direct Current Stimulation in negative symptoms of schizophrenia as measured by proton magnetic spectroscopic findings of left dorsolateral prefrontal cortex.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Diagnosis of Schizophrenia using Diagnostic Criteria for Research (DCR) of International Classification of Disease-10th edition (ICD-10, World Health Organization,1992) 2.Age between 18- 60 years of either sex 3.The Positive and Negative Syndrome Scale for Schizophrenia (PANSS) negative symptoms score of more than 15 4.Scale for Assessment of Negative Symptoms (SANS) score more than 20 5.Calgary Depression Scale for Schizophrenia (CDSS) score less than 7 6.Right handed 7.Patients giving written informed consent.
排除标准
- •1.Presence of co-morbid neurological or other psychiatric disorder(s).
- •2.Patient with co morbid substance dependence, except nicotine and caffeine.
- •3.Having any metallic implants/parts in body 4.Subjects who have received Electroconvulsive therapy in past 6 months.
结局指标
主要结局
Primary outcome of the study is change in negative symptoms score as assessed at the end of 2 weeks of HDtDCS treatment with the specially designed score sheet.
时间窗: PANSS, SANS, CGI, CDSS WILL BE APPLIED AT THE END OF 2 WEEKS & 6WEEKS
次要结局
- Secondary outcomes are changes in the levels of GABA, Glutamate, Glutamine, N-Acetyl Aspartate & N-Acetyl Aspartyl Glutamate in Dorsolateral Prefrontal Cortex using Proton MR Spectroscopic imaging and overall severity scores on CGI.(Proton Magnetic Resonance Spectroscopy will be done before giving HD tDCS and after 2 sessions of HD tDCS and at the end of 2 weeks.)