Neurobiological Correlates of the Effect of Add-On HD-tDCS for Working Memory Deficit in Schizophrenia
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- 1. Severity of Working memory deficits.
研究概览
简要总结
Schizophrenia, in addition to the positive and negative symptoms, is associated with impairments in cognitive functioning. Working memory (WM) is one of the cardinal deficits related to certain core symptoms of schizophrenia. WM impairment is a major predictor of functional outcome and quality of life in schizophrenia; WM deficits are not generally responsive to standard antipsychotic treatment. Transcranial direct current stimulation (tDCS) is a novel non-invasive focal brain stimulation technique using a low intensity direct current between two electrodes placed over the scalp. tDCS adaptively modulates neuroplasticity; this is partly dependent on BDNF regulation as well as genetic variation (val66met). Contextually, impaired BDNF function underlies WM deficits in schizophrenia. Very recently, an optimized version of tDCS, namely – High- Definition tDCS (HD-tDCS), has been proposed and studies have demonstrated superiority of this technique in terms of focalized neuromodulation as well as longer lasting adaptive plasticity effects. In this background, the current study, a randomized double blinded, placebo controlled trial will explore the neurobiological correlates of the effect of Add-On HD-tDCS for WM Deficits in Schizophrenia with the following objectives: a) To evaluate the neurobiological correlates of the effect of add-on HD-tDCS in patients with schizophrenia with deficient working memory ; b) To examine the neurobiological correlates (functional MRI activation as well as BDNF gene variation and expression) of WM deficit in schizophrenia. The potential translational implications of the study include: Understanding neurobiology of WM deficits in schizophrenia; Novel neurobiological correlates of clinical response to HD-tDCS in patients with schizophrenia with WM deficits; Development of personalized neuromodulation for treating schizophrenia in future.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- All
入选标准
- •Diagnosis of Schizophrenia and related disorders as per DSM criteria(Diagnostic and Statistical Manual for Mental Disorders, American Psychiatric Association), Right-handed, Lack of clinically significant positive symptoms as per established criteria and patient being on stable medications, Minimum education upto 8th standard, having significant cognitive deficits according to predefined criteria, Written informed consent obtained.
排除标准
- •Any contraindication to tDCS procedure (for example, metal in the head, implanted brain medical devices, local lesion or injury in the scalp/head), Co-morbid substance dependence (except tobacco and caffeine), Co-morbid neurological disease, Left/Mixed Handedness.
结局指标
主要结局
1. Severity of Working memory deficits.
时间窗: Twice. First time (Day 1), before the treatment | with HD-tDCS is given. And second time on the last day(day 5), after the completion of 10 session of HD-tDCS treatment.
2. Change in the neural correlates involved in Working memory deficits(Using brain imaging techniques like, structural MRI,resting fMRI, task based fMRI)
时间窗: Twice. First time (Day 1), before the treatment | with HD-tDCS is given. And second time on the last day(day 5), after the completion of 10 session of HD-tDCS treatment.
次要结局
- Change in the neural correlates involved in Working memory deficits(Using brain imaging techniques like, structural MRI,resting fMRI, task based fMRI)(Twice. First time (Day 1), before the treatment)