Impact of Cerebellar TMS on Brain and Cognitive Functions in Schizophrenia: a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Cerebellar function
研究概览
简要总结
This is a single-site, sham-controlled, randomized trial in a total of 40 subjects between ages 18 and 60 years with schizophrenia. This study will investigate the effects of 4-week rTMS treatment on brain and cognitive functions in patients. Subjects will be randomized to one of the following arms:
Arm 1: Standard of Care (SOC) and active rTMS Arm 2: Standard of Care (SOC) and sham rTMS
Each participant will receive rTMS five days per week, for four consecutive weeks. Functional magnetic resonance imaging (fMRI) scans, clinical assessments, and cognitive tests will be performed at baseline, end of the 2nd week, and end of the 4th week.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subjects 18 to 60 years of age
- •DSM-V diagnosis of schizophrenia spectrum disorders
- •Competent to provide informed consent
排除标准
- •Lifetime DSM-V diagnosis of an Axis-I disorder other than schizophrenia spectrum disorders
- •Lifetime diagnosis of ataxia or other cerebellar disorders
- •Lifetime diagnosis of mental retardation, dementia, Alzheimer's disease, Parkinson's disease, Huntington's disease, or other neurodegenerative disorders
- •Any active general medical condition or CNS disease which can affect cognition or response to treatment
- •Substance dependence or abuse in the past six months
- •Seizure history
- •TMS within three months or ECT within six months
- •Pregnancy as indicated by self-report
- •MRI contraindications
结局指标
主要结局
Cerebellar function
时间窗: end of 2nd week and 4th week
Changes of cerebellar connectivity after TMS treatment compared with baseline, as measured by functional magnetic resonance imaging (fMRI)
次要结局
- Cognitive function(end of 2nd week and 4th week)
研究者
Hengyi Cao
Associate Professor
Northwell Health