Effect of Transcranial Direct Current Stimulation (tDCS) on Inflammatory Biomarkers in Chronic Schizophrenia: A Randomised Double-Blind Controlled Trial.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Change in the IL-6 levels
研究概览
简要总结
The study is a randomized, double-blind, parallel-arm, sham-controlled trial that aims to compare the effects of transcranial direct current stimulation (tDCS) versus sham stimulation on inflammatory markers (IL-6 and TNF-alpha) and clinical outcomes (PANSS, AHRS, CGI-SCH, GAF) in patients with chronic schizophrenia over 10 days of treatment. The primary objective is to assess changes in IL-6 levels, while secondary objectives include evaluating changes in TNF-alpha, symptom scales, and adverse events. The study will be conducted at the psychiatry department of AIIMS Bhubaneswar, with 60 patients aged 18-60 years with moderate-to-severe schizophrenia symptoms randomized to receive either active tDCS (cathode over left temporo-parietal junction, anode over left dorsolateral prefrontal cortex) or sham stimulation. The researchers hope to elucidate the potential immunomodulatory effects of tDCS and its impact on symptoms in chronic schizophrenia, which may lead to more targeted, multifaceted interventions to improve patient outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients clinically diagnosed with schizophrenia (F20 according to ICD-11) for a period more than 2 years receiving antipsychotics.
- •2. Moderate to severe symptoms (PANSS score >75 and/or CGI-SGH score >4)
- •Patients of both sex 18-60 years
- •Right-handed.
- •Legally authorized representative (LAR) giving voluntary written consent for participation in the study.
排除标准
- •1. Patients with chance of pregnancy.
- •Any psychiatric emergency (e.g. suicidal risk, catatonia, prolonged nutritional deprivation) or others (e.g.: aggression or excitement)
- •Co-morbid neurological disease: i) History of migraine. ii) History of seizure/epilepsy. iii) History of head trauma or organic disease.
- •4. Any contraindication to tDCS procedure: i) Injury or local lesion in the scalp/head ii) Metallic implants in the head iii) Implanted brain medical devices
- •Left-handed.
结局指标
主要结局
Change in the IL-6 levels
时间窗: 10 days
次要结局
- To compare the adverse events reported in both control and intervention groups.(5 days and 10 days)
- Change in the Positive and Negative syndrome Scale(5 days and 10 days)
- Change in the Auditory hallucination rating scale(5 days and 10 days)
- Change in the Clinical global impression- Schizophrenia scale(5 days and 10 days)
- Change in the TNF alpha levels.(10 days)
- Change in the Global Assessment of Functioning scale(5 days and 10 days)
研究者
Dr. Debadatta Mohapatra
Associate Prof
All India Institute of Medical Sciences, Bhubaneswar