Modulating self-referential and interoceptive processing using transcranial alternating current stimulation (tACS): An open-label study to enhance recovery in schizophrenia
试验速览
- 阶段
- 2/3 期
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Social and occupational functioning
研究概览
简要总结
The study aims to modulate the intrinsic neural oscillations at a crucial hierarchical region, left dorsolateral prefrontal cortex (left DLPFC), using individualised accelerated high-definition theta-tACS and evaluate its impact on overall recovery as measured by the functioning at the 6th week of stimulation. We plan to evaluate the functioning as the primary outcome as the ultimate aim of management in schizophrenia and functional impairment does not always correlate with any single symptom domain. Moreover, subtle manifestations such as basic symptoms of self and cognitive deficits, among others, are not always comprehensively captured by the symptom rating scales but contributes to dysfunction. We hypothesize that the functional recovery using theta-tACS would be mediated through changes in interoception (heart rate variability, electrogastrography), self-referential processing and psychopathology.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Diagnosis of psychotic disorder as per International Classification of Diseases 10 at least as minimal sociooccupational dysfunction SOFAS more than
- •On a stable medication for the last 6 weeks with no major functionality in this 6 week period Providing written informed consent only patients with intact capacity to consent will be approached.
排除标准
- •Features suggestive of risk of harm to self (for example: suicidal risk, catatonia, prolonged nutritional deprivation) or others (for example: aggression or excitement) Need for Electroconvulsive therapy Recent history of antibiotic usage within the past 6 weeks Co-existing inflammatory bowel disease Co-morbid substance dependence (except caffeine and nicotine) Any significant medical or neurological disorder or condition affecting auditory, visual or any sensory modalities which remain uncorrected Any local skin lesion near the site of stimulation or any other contraindication to tACS.
结局指标
主要结局
Social and occupational functioning
时间窗: 6 week
次要结局
- heart rate variability markers(electrogastrography markers)
研究者
Dr. Sreeraj V S
National Institute of Mental Health and Neurosciences (NIMHANS)