Intermittent Theta Burst Stimulation of the Precuneus for the Treatment of Resistant Schizophrenia
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- average of the Scale for assessment of negative symptoms/scale for assessment of positive symptoms scale scores
研究概览
简要总结
The purpose of the study is to compare the effectiveness of stimulation of the left precuneus by intermittent Theta Burst Stimulation to placebo stimulation on the severity of schizophrenia symptoms.
详细描述
This is an interventional, prospective, randomized, double-blind, multicenter study, comparing iTBS treatment (experimental group) of the precuneus to placebo stimulation (control group) of patients suffering from resistant schizophrenia and having been exposed to childhood trauma.
The study population will be patients aged 18 to 40 years old exposed to childhood trauma, presenting with schizophrenia resistant to antipsychotic treatments.
This study will be implemented in 4 investigative centers. Each patient will participate for a period of 3 months.
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
- Double (Participant, Investigator)
盲法说明
Remote coil change while keeping the patient and investigator blind
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Right-handed patient aged 18 to 40 years inclusive;
- •Patient presenting schizophrenia as defined in the Diagnostic and Statistical Manual-5;
- •Patient under antipsychotic treatment in accordance with the recommendations of the High Authority of Health, at a stable dosage and without modification of psychotherapeutic treatment for at least 4 weeks;
- •Patient on mono or dual antipsychotic therapy.
- •Patient presenting residual symptoms, i.e. absence of remission defined by the criteria of the "Remission criteria of the Schizophrenia Working Group Consensus";
- •Patient having been exposed to at least one type of trauma in childhood and having a score higher than the threshold values of the childhood trauma questionnaire: emotional neglect, physical abuse, emotional abuse, physical neglect, sexual abuse;
- •Patient having signed an informed consent form to participate in the study.
排除标准
- •Patient with a contraindication to magnetic resonance imaging or intermittent Theta Burst Stimulation (presence of a metallic body, pacemaker, implantable defibrillator or other implantable metallic device, epilepsy, stroke or recent head trauma);
- •Patient who is not French-speaking or cannot read and write;
- •Patient under guardianship;
- •Patient in forced care (psychiatric care upon decision of the State representative and psychiatric care at the request of a third party);
- •Pregnant woman or likely to be pregnant (of childbearing age) without effective contraception or breastfeeding;
- •Patient participating in another clinical trial, or during a period of exclusion from another clinical trial;
- •Patient who is not a beneficiary of a social security system.
- •Patient who, according to the assessment of the investigator, risks not being compliant or diligent in the study procedures.
研究组 & 干预措施
experimental group with intermittent Theta Burst Stimulation
The procedure under study is the use of a stimulation device to perform intermittent Theta Burst Stimulation treatment on the precuneus to treat resistant schizophrenia. Targeting requires a neuronavigation device.
干预措施: stimulation device (Procedure)
control group with placebo stimulation
In the control group, stimulation is simulated using a "Sham" or placebo coil. The stimulation device is the same as for the experimental group, only the coil differs.
干预措施: stimulation device (Procedure)
结局指标
主要结局
average of the Scale for assessment of negative symptoms/scale for assessment of positive symptoms scale scores
时间窗: 21 days
The Primary Outcome Measure will be assessed by the average of the Scale for assessment of negative symptoms/scale for assessment of positive symptoms scale scores at approximately 21 days compared to the score at inclusion in the two groups.
次要结局
未报告次要终点