Repetitive Transcranial Magnetic Stimulation on Appetite and Cognitive Function in Schizophrenia
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Change of Appetite
研究概览
简要总结
The weight gain and metabolic dysfunction has been vital conditions for individuals with schizophrenia. rTMS is a promising novel intervention, which have strong potentials on moderating increased appetite and cognitive deficits in schizophrenia, as it has been proved for the treatment of depression.
Therefore, the investigators designed this randomized controlled clinical trial to evaluate the efficacy and safety of rTMS, using iTBS pattern, on prevention and treatment for elevated appetite and cognitive deficiency in individual with schizophrenia.
详细描述
The weight gain and metabolic dysfunction has been vital conditions for individuals with schizophrenia. The cognitive function deficit has also been a major symptom for schizophrenia. However, metabolic dysfunction could further impair the cognition. rTMS is a promising novel intervention, which have strong potentials on moderating increased appetite and cognitive deficits in schizophrenia, as it has been proved for the treatment of depression.
Therefore, the investigators designed this randomized controlled clinical trial to evaluate the efficacy and safety of rTMS, using iTBS pattern, on prevention of the elevated appetite and cognitive deficiency in individual with schizophrenia. The intervention will last for 5 continuous days and the follow-ups are scheduled at baseline, 6days and 36days. The primary outcomes include the change of MCCB score, TFEQ score and EEG data. Secondary outcomes include the change of serum metabolic indexes and anthropometry indexes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Patients with schizophrenia in accordance with DSM-5
- •Commorbid with significant weight gain after antipsychotics
- •Informed Consent
排除标准
- •Diagnosed with other mental disease in accordance with DSM-5
- •Comorbid with other severe physiological disease
- •Used antipsychotic, antidepressants, mood stabilizer, or other psychoactive substances before
- •Drug or alcohol abuse
- •Pregnant or lactating
- •Contraindication to rTMS
研究组 & 干预措施
iTBS stimulation
The participants randomized into experimental group will receive iTBS stimulation of dlPFC 5 times a day, with 1h interval between two stimulations, and for 5 continuous days.
干预措施: iTBS (Device)
Sham stimulation
The participants randomized intoSham group will receive Sham stimulation, as the coil vertical to the brain surface, 5 times a day, with 1h interval between two stimulations, and for 5 continuous days.
干预措施: Shame stimulation (Device)
结局指标
主要结局
Change of Appetite
时间窗: Change from Baseline to 6days and 36days
Three-Factor Eating Questionnaire
Change of MCCB
时间窗: Change from Baseline to 6days and 36days
The MATRICS™ Consensus Cognitive Battery
Change of ERP
时间窗: Change from Baseline to 6days and 36days
Food picture ERP recorded by EEG
次要结局
- Change of fasting insulin level(Change from Baseline to 6days and 36days)
- Change of fasting glucose(Change from Baseline to 6days and 36days)
- Change of Triglyceride(Change from Baseline to 6days and 36days)
- Change of Total Cholesterol(Change from Baseline to 6days and 36days)
- Change of LDL(Change from Baseline to 6days and 36days)
- Change of HDL(Change from Baseline to 6days and 36days)
- Change of BMI(Change from Baseline to 6days and 36days)
研究者
Renrong Wu
Professor
Central South University