Effects of Transcranial Magnetic Stimulation on Motor Symptoms of Patients With Psychiatric Disorders
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Number of Responders at Week 3
研究概览
简要总结
Psychomotor slowing may occur in major psychiatric disorders, such as major depressive disorders or schizophrenia spectrum disorders. It refers to slowing of fine motor skills, motor planning and gross motor behavior. In major depression and schizophrenia, psychomotor slowing is associated with alterations of premotor cortex, dorsolateral prefrontal cortex and basal ganglia. This randomized, sham-controlled, prospective trial will test, whether 15 sessions of repetitive transcranial magnetic stimulation (rTMS) may ameliorate psychomotor slowing in schizophrenia or major depression.
详细描述
Psychomotor slowing may occur in major psychiatric disorders, such as major depressive disorders or schizophrenia spectrum disorders. It refers to slowing of fine motor skills, motor planning and gross motor behavior. In major depression and schizophrenia, psychomotor slowing is associated with alterations of premotor cortex, dorsolateral prefrontal cortex and basal ganglia. This randomized, sham-controlled, prospective trial will test, whether 15 sessions of rTMS in 3 weeks may ameliorate psychomotor slowing in schizophrenia or major depression.
Eligible participants will be randomized to one of four arms:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
double-blind
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •suffering from major depressive disorder or schizophrenia spectrum disorder according to DSM-5 criteria
- •right handedness
- •normal or corrected-to-normal vision and hearing
排除标准
- •history of severe head trauma
- •current abuse of drugs or alcohol; past addiction to drugs or alcohol
- •pregnancy
- •incompatibility to cerebral MRI
结局指标
主要结局
Number of Responders at Week 3
时间窗: week 3
Number of participants with \>30% reduction from baseline in the Salpetriere Retardation Rating Scale, last observation carried forward method applied
次要结局
- Change in Hand Gesture Performance From Baseline to Week 3(week 3)
- Change in Salpetriere Retardation Rating Scale Total Score From Baseline to Week 3(week 3)
- Change in Activity Level From Baseline to Week 3(week 3)
- Change in SANS Total Score From Baseline to Week 3(week 3)
- Change in CAINS Total Score From Baseline to Week 3(week 3)
- Change in PANSS Total and Subscores From Baseline to Week 3(week 3)
- Change in Coin Rotation From Baseline to Week 3(week 3)
- Change in Catatonia Severity From Baseline to Week 3(week 3)
- Change in Fingertapping Score From Baseline to Week 3(week 3)
- Change From HAMD Total Score From Baseline to Week 3(week 3)
研究者
Sebastian Walther
Prof. Dr., Head of the outpatient clinic, University Hospital of Psychiatry
University of Bern