A Study on the Brain Mechanism of cTBS in Improving Medication-resistant Auditory Hallucinations in Schizophrenia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Psychotic Symptom Rating Scales-Auditory Hallucination Subscale (PSYRATS-AH)
研究概览
简要总结
This study is dedicated to exploring the brain mechanism of medication-resistant auditory hallucinations and developing effective treatment methods for them by using both cross-sectional and longitudinal designs. The continuous theta burst stimulation(cTBS) treatment mode, with the left cerebellum Crus II as the stimulation target, is applied to treat the schizophrenia patients with the medication-resistant auditory hallucinations. At the same time, the first-episode schizophrenia patients with auditory hallucinations were recruited as a test cohort to examine that brain mechanism of general auditory hallucinations in schizophrenia may be the structural and functional abnormalities in the temporoparietal circuit.
详细描述
Previous studies have shown that repetitive transcranial magnetic stimulation (rTMS) targeted at the temporal-parietal junction can effectively treat genenal auditory hallucinations in schizophrenia, but it is not the case for medication-resistant auditory hallucinations. Studies suggested that rTMS targeted at the left Crus II might be effective for medication-resistant auditory hallucinations. This study is dedicated to exploring the brain mechanism of medication-resistant auditory hallucinations and developing effective treatment methods for them by using both cross-sectional and longitudinal designs. The continuous theta burst stimulation(cTBS) treatment mode, with the left cerebellum Crus II as the stimulation target, is applied to treat the schizophrenia patients with the medication-resistant auditory hallucinations. Assessment with symptomatology, neuropsychology, neuroimaging, and machine learning methods is utilized to examine the investigators hypothesis that structural and functional abnormalities of the cerebral cortico-cerebellar-thalamic-cortical circuit (CCTCC) may contribute to brain mechanism of medication-resistant auditory hallucinations in schizophrenia. At the same time, the first-episode schizophrenia patients with auditory hallucinations were recruited as a test cohort to examine that brain mechanism of general auditory hallucinations in schizophrenia may be the structural and functional abnormalities in the temporoparietal circuit, whereas structural and functional abnormalities of the CCTCC may contribute to brain mechanism of medication-resistant auditory hallucinations in schizophrenia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Written informed consent
- •18-45 years old, right-handed
- •Meet the diagnostic criteria for schizophrenia according to the Structural Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V)
- •After a sufficient course of antipsychotic treatment (more than 6 weeks, two or more antipsychotic drugs, at least one of which is the second generation of atypical antipsychotic drugs), auditory hallucinations occurred more than 5 times a day for more than 6 months
- •Stable antipsychotic medication 4 weeks before and during the treatment (except auditory hallucination symptoms)
排除标准
- •A history of epilepsy, convulsions, stroke or other serious brain diseases
- •There are serious infectious diseases, malignant tumors, and severe somatic comorbidity
- •Mental retardation, personality disorder and so on
- •Contraindications for magnetic resonance imaging
- •Diagnose of substance dependence or abuse as primary clinical problem
- •Participants had received Modified Electraconvulsive Therapy (MECT) or TMS treatment in recent 6 months
研究组 & 干预措施
The schizophrenia patients with medication-resistant auditory hallucinations
Drug + cTBS intervention (the left cerebellum Crus II as the stimulation target)
干预措施: Antipsychotic drugs (Drug)
The schizophrenia patients with medication-resistant auditory hallucinations
Drug + cTBS intervention (the left cerebellum Crus II as the stimulation target)
干预措施: cTBS （the left cerebellum Crus II as the stimulation target） (Device)
The schizophrenia patients with general auditory hallucinations
Drug intervention
干预措施: Antipsychotic drugs (Drug)
Drug + cTBS intervention: the first-episode schizophrenia patients with auditory hallucinations
Drug + cTBS intervention (the left temporoparietal cortex as the stimulation target)
干预措施: Antipsychotic drugs (Drug)
Drug + cTBS intervention: the first-episode schizophrenia patients with auditory hallucinations
Drug + cTBS intervention (the left temporoparietal cortex as the stimulation target)
干预措施: cTBS（the left temporoparietal cortex as the stimulation target） (Device)
Drug intervention: the first-episode schizophrenia patients with auditory hallucinations
Drug intervention
干预措施: Antipsychotic drugs (Drug)
The schizophrenia patients with medication-resistant auditory hallucinations from the fourth arm
Drug + cTBS intervention (the left cerebellum Crus II as the stimulation target)
干预措施: Antipsychotic drugs (Drug)
The schizophrenia patients with medication-resistant auditory hallucinations from the fourth arm
Drug + cTBS intervention (the left cerebellum Crus II as the stimulation target)
干预措施: cTBS （the left cerebellum Crus II as the stimulation target） (Device)
结局指标
主要结局
Psychotic Symptom Rating Scales-Auditory Hallucination Subscale (PSYRATS-AH)
时间窗: From baseline to 10 weeks
The Psychotic Symptom Rating Scales-Auditory Hallucination Subscale (PSYRATS-AH) is an instrument designed to quantify the severity of hallucinations before and after treatment at different follow up point. Raw score range is 0-44. A higher score indicates a worse outcome.
Structural and Function MRI data
时间窗: From baseline to 10 weeks
A 3.0 T Siemens scanner was used to obtain the fMRI images in the Second Xiangya Hospital of Central South University.The MRI data wii be obtained before and after treatment at different follow up point.
Positive and Negative Syndrome Scale (PANSS)
时间窗: From baseline to 10 weeks
The PANSS total scores, subscale scores were used to evaluate the severity of psychotic symptoms for schizophrenia before and after treatment at different follow up point.The total score of the PANSS was more than 60.The higher scores mean a worse outcome.
次要结局
- Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)(From baseline to 10 weeks)
- The Stroop test(From baseline to 10 weeks)
- Wisconsin Card Sorting Test (WCST)(From baseline to 10 weeks)
研究者
Guo Wenbin
Professor of Psychiatry Department of Psychiatry of the Second Xiangya Hospital, Central South University
Central South University