Transcranial Alternating Current Stimulation (tACS) as an Augmentation Treatment for Negative Symptoms and Cognitive Deficits in Long-term Hospitalized Schizophrenia Patients
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- EEG
研究概览
简要总结
This study aims to evaluate the efficacy of transcranial alternating current stimulation (tACS) on negative symptoms and cognitive function in long-term hospitalized patients with schizophrenia. At the same time, this study will explore the potential impact of relevant biomarkers and genetic factors on the efficacy of tACS intervention.
详细描述
- Research purpose (1) This study aims to explore the synergistic therapeutic effect of tACS on negative symptoms and cognitive function in long-term hospitalized schizophrenia patients; (2) Using emotion-induced EEG activity in a virtual reality context as a biomarker, analyze its correlation with the clinical efficacy of tACS.
- Expected results (1) It is confirmed that tACS can improve negative symptoms and cognitive function in long-term hospitalized schizophrenia patients; (2) Biomarkers can be used to predict the efficacy of tACS in improving negative symptoms and cognitive function in long-term hospitalized schizophrenia patients, and guide clinical precision application.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Inclusion criteria for long-term hospitalized schizophrenia patients:
- •Diagnosed with DSM-5 schizophrenia and hospitalized for more than half a year
- •Aged between 18 and 65 years old
- •Willing to participate in the study and sign the informed consent
- •Stable condition, PANSS total score changed less than 15% at least 2 months before the study.
- •Education level above primary school
- •Normal vision or normal after correction
- •Inclusion criteria for normal control group:
- •No diagnosed mental illness
- •Aged between 18 and 65 years old
- •Willing to participate in the study and sign the informed consent
- •Education level above primary school
- •Normal vision or normal after correction
- •Residents living in Pudong community
排除标准
- •Exclusion criteria for long-term hospitalization of schizophrenia patients:
- •Combined diagnosis of other mental illnesses in DSM-5
- •History of severe neurological diseases, epilepsy, craniocerebral trauma, etc.
- •Severe organic diseases of the heart, liver, kidney and other organs that are unstable
- •Infectious skin diseases
- •Use of other drugs that affect the results during the study, such as benzodiazepines, non-benzodiazepine sedatives, and psychostimulants
- •Pregnant or lactating women
- •Patients with claustrophobia
- •Patients with alcohol, drugs Abuse history
- •Patients who have received TACS treatment in the past and have no effect or intolerance
- •Exclusion criteria for normal control group:
- •Patients with a history of severe neurological diseases, epilepsy, craniocerebral trauma, etc.
- •Patients with severe organic diseases that cause instability of organs such as heart, liver, and kidney
- •Patients with infectious skin diseases
- •During the study, drugs that affect the results were used in combination, such as benzodiazepines, non-benzodiazepine sedatives, and psychostimulants
- •Pregnant or lactating women
- •Patients with claustrophobia
- •Patients with a history of alcohol and drug abuse -
结局指标
主要结局
EEG
时间窗: Day 1 after tACS intervention
resting EEG power spectrum
Brief Negative Symptom Scale (Bnss)
时间窗: Day 4 after tACS intervention
The Brief Negative Symptom Scale (BNSS) ranges from 0 to 78, with higher scores indicating more severe negative symptoms.
MATRICS Consensus Cognitive Battery，MCCB
时间窗: Day 4 after tACS intervention
The MATRICS Consensus Cognitive Battery (MCCB) does not have a fixed total score range, as it consists of multiple tests assessing different cognitive domains. Each domain score is standardized as a T-score, typically ranging from approximately 0 to 100, with higher scores indicating better cognitive performance.
The Clinical Assessment Interview Scale
时间窗: Day 4 after tACS intervention
The Clinical Assessment Interview Scale for Negative Symptoms (CAINS) ranges from 0 to 52 , with higher scores indicating more severe negative symptoms.
EEG
时间窗: Day 1 after tACS intervention
resting EEG power spectrum
Eye Tracking
时间窗: Day 1 after tACS intervention
Binocular saccade amplitude and direction
Brief Negative Symptom Scale (Bnss)
时间窗: Day 4 after tACS intervention
The Brief Negative Symptom Scale (BNSS) ranges from 0 to 78, with higher scores indicating more severe negative symptoms.
MATRICS Consensus Cognitive Battery，MCCB
时间窗: Day 4 after tACS intervention
The MATRICS Consensus Cognitive Battery (MCCB) does not have a fixed total score range, as it consists of multiple tests assessing different cognitive domains. Each domain score is standardized as a T-score, typically ranging from approximately 0 to 100, with higher scores indicating better cognitive performance.
The Clinical Assessment Interview Scale
时间窗: Day 4 after tACS intervention
The Clinical Assessment Interview Scale for Negative Symptoms (CAINS) ranges from 0 to 52 , with higher scores indicating more severe negative symptoms.
次要结局
未报告次要终点
研究者
Weiqing Liu
Dr.
Tongji University