NCT01072617已完成不适用
Safety and Therapeutic Efficacy of Cerebellar Repetitive Transcranial Magnetic Stimulation in Patients With Schizophrenia
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Adverse Events
研究概览
简要总结
The primary aim of this protocol is to determine whether the use of repetitive transcranial magnetic stimulation (rTMS) over vermis of the cerebellum may be safe and therapeutically effective in patients with schizophrenia. Because this is the first evaluation of this treatment in this population, the focus of this study is safety.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age between 18-65 years
- •Diagnosis of schizophrenia according to DSM-IV criteria(by a board-certified psychiatrist)
排除标准
- •Prior neurosurgical procedures
- •Any history of seizure
- •Previous head injury
- •Contraindication to TMS:
- •Implanted pacemaker
- •Medication pump
- •Vagal stimulator
- •Deep brain stimulator
- •Metallic hardware in the head or scalp: shrapnel, surgical clips, or fragments from welding
- •Signs of increased intracranial pressure
- •TENS unit and ventriculo-peritoneal shunt
- •Pregnancy or lactating; note that a negative pregnancy test will be required if the patient is a female in reproductive years
- •Advanced liver, kidney, cardiac, or pulmonary disease as defined clinically or a terminal medical diagnosis consistent with survival < 1 year
- •A history of significant alcohol or drug abuse in the prior six months
- •No focal cortical insult can be present, including tumor or vascular malformation
- •Patients may not be actively enrolled in a separate intervention study
- •Patients unable to undergo a brain MR:
- •a. claustrophobia refractory to anxiolytics ferromagnetic metal in the body such as a prosthetic heart valve, a pacemaker, or a brain aneurysm clip).
- •Change in antipsychotic medication during the last 4 weeks
- •Any emergency psychiatry department visit during the last 4 weeks
- •Been an inpatient in a psychiatry clinic within the last month
- •Any other axis I diagnosis
结局指标
主要结局
Adverse Events
时间窗: 3 weeks
Adverse event collection at baseline, daily for 5 days during treatment, every other day by phone until the final assessment at week 1 follow up visit.
次要结局
- Positive and Negative Syndrome Scale (PANSS) - Negative Subscale(Baseline, 5 days (post-treatment), 1 week post treatment)
- Positive and Negative Syndrome Scale (PANSS) - Positive Subscale(Baseline, 5 days (post-treatment), 1 week post treatment)
- Positive and Negative Syndrome Scale (PANSS) - General Subscale(Baseline, 5 days (post-treatment), 1 week post treatment)
研究者
Alvaro Pascual-Leone
Professor of Neurology
Beth Israel Deaconess Medical Center
研究点 (2)
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