RTMS for Clinical High-risk Syndrome of Psychosis Based on Personalized Targets Using Magnetoencephalography
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Reduction rate of the SIPS/SOPS scale
研究概览
简要总结
This study is an before-after study in the same subject, which enrolled 26 individuals with high-risk psychiatric syndrome (CHR). The target of subjects intervention relies on the results of magnetoencephalography localization. The medication and dosage remain unchanged during the intervention period or not yet taking antipsychotic medication. The investigators assume that the intervention targets for each CHR subject are individualized.
详细描述
This study is divided into two parts:
- Target determination. Firstly, MEG data of the subject's resting and task states are collected, and a precise localization model using magnetoencephalography is applied to locate the precise location of the subject's abnormal signals in the brain, which is then used as the intervention target. Based on the subject's tolerance for single day intervention, the appropriate number of targets is generally 2-4. The upper limit of targets is 4.
- RTMS individualized intervention. Application of rTMS for 1Hz low-frequency intervention, with intervention parameters of 1400 sessions, 100% exercise threshold, and a total of 23 minutes per session. After each target intervention, rest for half an hour to one hour. The pseudo stimulation intervention lasted for 10 days in the first and second weeks, and the scale was evaluated after the end of the pseudo stimulation. After resting for 2 weeks, enter the 3-4 weeks of real stimulation, with 5 days of intervention per week for a total of 10 days. 2-4 targets per day, 23 minutes per target, with 30-60 minutes between interventions for each target. After the fourth week, evaluate the scale. Follow up evaluations will be conducted on the 7th, 14th, 30th, 60th, and 90th day after intervention. By analyzing and evaluating data, explore individualized treatment plans for CHR in clinical practice.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 13 Years 至 35 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of Clinical High-Risk Syndrome for Psychosis
- •Must be able to right-handed
- •Primary school education or above
- •Understand and sign a written informed consent form (jointly signed by the guardian and the participant if under 18 years old)
排除标准
- •Major physical illnesses (organic lesions such as sensory and motor disorders, neurological disorders, and traumatic brain injury)
- •Taboo symptoms for rTMS treatment (such as intracranial metal implants)
- •Metal (including orthodontic treatment, dental implants) and tattoos inside the body
- •Claustrophobia
结局指标
主要结局
Reduction rate of the SIPS/SOPS scale
时间窗: From enrolment to the end of the 2-week pseudostimulation treatment. From 2 weeks rest after the end of pseudostimulation treatment to the end of 2 weeks of true stimulation treatment.
SIPS/SOPS (Structured Interview for Psychosis-Risk Syndromes/Scale of Psychosis-Risk Symptoms) is a scale used to assess subjects' structural interviews on prodromal symptoms of psychosis. The SIPS/SOPS scales, due to their inclusion of multiple assessment items with potentially varying scores for each, do not allow for a straightforward determination of an overall minimum and maximum value. A higher score indicates more severe symptoms in the assessed individual, while a lower score suggests less severe symptoms.
次要结局
- Reduction rate of the PNASS scale(From enrolment to the end of the 2-week pseudostimulation treatment. From 2 weeks rest after the end of pseudostimulation treatment to the end of 2 weeks of true stimulation treatment.)