CTRI/2021/07/034759尚未招募3 期
Effectiveness Of Adjuvant HDtDCS On Functional Connectivity On Cognitive And Negative Symptoms Of Schizophrenia : A Controlled fMRI Study
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Reduction in scores on negative and cognitive symptoms after application of HDtDCS.
研究概览
简要总结
Schizophrenia is a chronic debilitating condition where the negative and cognitive symptoms cause functional impairment even after positive symptoms resolve. High definition transcranial direct current stimulation is a non invasive and cost effective neuomodulatory technique with promising results for negative and chronic symptoms of schizophrenia. HDtDCS is a technically enhanced version of tDCS giving a more focal stimulation and has a better predictive stimulation output which will be assessed on clinical rating scales and fMRI.
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.Duration of illness to be more than or equal to two years.
- •3.Age between 18- 60 years of either sex 4.The Positive and Negative Syndrome Scale for Schizophrenia (PANSS) negative symptoms score of more than 15 5.Scale for Assessment of Negative Symptoms (SANS) score more than 20 6.Right-handed 7.Educated upto class VIII or above 8.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 ECT in past 6 months.
- •5.Colour blind.
结局指标
主要结局
Reduction in scores on negative and cognitive symptoms after application of HDtDCS.
时间窗: 1. At baseline | 2. At the end of 2 weeks | 3. At the end of 4 weeks
次要结局
- Change in fMRI activation of Pre Frontal Cortex using cognitive task and change in resting state functional connectivity at baseline and after application of HDtDCS.(1. At baseline)
研究者
研究点 (1)
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