Efficacy and safety of extended high-definition transcranial direct current stimulation (hd- tdcs) in enhancing cognitive function in schizophrenia: a randomized, double-blind, sham-controlled trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Change in Hindi MoCA and SCoRS scores across T0, T1, and T2.
研究概览
简要总结
Schizophrenia is a chronic, disabling psychiatric disorder that affects approximately 20 million people worldwide.
It is characterized by positive symptoms (hallucinations, delusions), negative symptoms (emotional flattening, social withdrawal), and notably, cognitive impairments.
These cognitive deficits—particularly in attention, working memory, executive function, and processing speed—are increasingly recognized as core features of the disorder.
Unlike positive symptoms, cognitive dysfunction typically predates psychosis and persists throughout the illness
Despite advancements in pharmacotherapy, especially with second-generation antipsychotics, medications offer limited efficacy for cognitive improvement.
This highlights an urgent need for adjunctive non-pharmacological interventions.
High-definition transcranial direct current stimulation (HD- tDCS) is a non-invasive neuromodulation technique that alters neuronal excitability by delivering low-intensity direct currents via scalp electrodes.
Anodal stimulation enhances excitability, while cathodal stimulation reduces it.
HD- tDCS is portable, low-cost, well-tolerated, and has shown promise for enhancing cognitive domains like working memory and executive functioning in schizophrenia.
When targeted at the left dorsolateral prefrontal cortex (DLPFC), HD- tDCS has demonstrated measurable cognitive benefits.
This study aims to investigate the effectiveness of HD- tDCS as a tool for cognitive enhancement in patients with schizophrenia, particularly in improving working memory, attention, and executive function.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Double
入排标准
- 年龄范围
- 18.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Provided written informed consent.
- •Diagnosis of schizophrenia as per (DSM-5 criteria).
- •Age: 18–50 years.
- •Patient should be stable on same antipsychotic medication.
- •Hindi MOCA score of less than 26.
排除标准
- •1.History of seizures or neurological disorders.
- •Patients with implanted metallic devices
- •Substance dependence (except nicotine or caffeine) in the past 6 months.
- •Any other major mental disorders.
- •Patients with neurological disorders with history of epilepsy, organic brain damage or any neurological procedures
- •Patients with significant unstable medical conditions like uncontrolled hypertension, complicated diabetes mellitus, organic failures, etc.
结局指标
主要结局
Change in Hindi MoCA and SCoRS scores across T0, T1, and T2.
时间窗: baseline, 15 days, 30 days
Analysis: Mixed-effects repeated-measures ANOVA with group (active vs. sham) as the between-subjects factor and time (T0, T1, T2) as the within-subjects factor, conducted separately for MoCA and SCoRS.
时间窗: baseline, 15 days, 30 days
次要结局
- Changes in PANSS, WHO-QOL, & CGI-S scores.
研究者
Dr Mohan Dhyani
Sri Guru Ram Rai Institute Of Medical and Health Sciences