Effect of Adjuvant Intermittent Theta Burst Stimulation For Cognitive Deficits In Schizophrenia:An ERP Based Sham Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Effect of theta burst stimulation for cognitive deficits and reduction in scores of Montreal Cognitive Assessment Test (MoCA), Digit Symbol Substitution Test (DSST)
研究概览
简要总结
Cognitive impairments have long been accepted as core features of schizophrenia that contribute significantly to disability and are generally treatment refractory. Numerous neuropsychological studies demonstrate a broad range of measurable cognitive deficits in Schizophrenia including impairments in attention, working memory (WM), episodic memory, processing speed and executive functions. Despite the enormous importance of cognitive symptoms, there are still no satisfying treatment options in clinical practice. Noninvasive brain stimulation (NIBS) techniques have been proposed as new treatment options for cognitive deficits. The term NIBS summarizes various techniques, including repetitive transcranial magnetic stimulation (rTMS) and its variants. Hence, attempts have been taken to design specific strategies that improve the cognitive deficits. Most of the studies of cognition has been done on dLPFC for cognition. At present, repetitive intermittent theta burst stimulation (iTBS) is a more novel form of rTMS. iTBS is a new form of NIBS, that is characterized by the delivery of 600 pulses within 3 minutes. It produces an increase in motor cortex excitability in a short time, and its excitatory effect may be superior to that of rTMS. Stimulating the dmPFC may increase the integration of information that would otherwise be processed in parallel to those important for self relevant processes. This embedding of information pertaining to the other could potentially explain how humans are able to represent the perspective of others and attribute observable behaviour to unobservable mental attributes. Based on an extensive review, Van Overwalle (2011) concluded that the mPFC is preferentially engaged in social cognition. Studies on rTMS on dmPFC for cognitive symptoms in schizophrenia are lacking. There is however one study been done on dmPFC stimulation on social cognition (Razafimandimby, A et al.,2016). Hence in this study other domains of cognitive deficits would be looked for the effects of iTBS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 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 -11th edition 2.Minimum 2 years duration of illness and on stable dose of antipsychotics 3.Patients will be screened for cognitive deficit with Montreal Cognitive Assesement Test (MOCA).Cut off score <25 4.Right handed.
排除标准
- •1.Presence of co-morbid neurological disorder 2.Diagnosed intellectual disability 3.Past history of seizure episode 4.Past history of head injury 5.Patients who have received electroconvulsive therapy in last 6 months.
结局指标
主要结局
Effect of theta burst stimulation for cognitive deficits and reduction in scores of Montreal Cognitive Assessment Test (MoCA), Digit Symbol Substitution Test (DSST)
时间窗: Effect of theta burst stimulation for cognitive deficits and reduction in scores of Montreal Cognitive Assessment Test (MoCA), Digit Symbol Substitution Test (DSST)
次要结局
- Comparison of amplitude & latency of P300 component of ERP between active & sham(Comparison of amplitude & latency of P300 component of ERP between active & sham)