Repetitive Transcranial Magnetic Stimulation (rTMS) to Improve Cognitive Function and Prevent Relapses in Bipolar Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Changes in the MATRICS Consensus Cognitive Battery
研究概览
简要总结
This study will investigate the effect of Repetitive transcranial magnetic stimulation (rTMS) on cognition and long-term clinical outcomes of bipolar patients.
详细描述
Cognitive deficits are core features of bipolar disorder. Preliminary evidence shows that repetitive transcranial magnetic stimulation (rTMS) might have positive effects in enhancing cognition and improving clinical symptoms in patients with depression. This study will investigate the effect of rTMS on cognition and long-term outcomes (12 month) of bipolar patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, 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
- •Bipolar Type I or II subjects diagnosed according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-5)
- •Age 18-60 years
- •Rating on 24-items Hamilton Depression Rating Scale (HAMD)<18
- •Rating on the Young Mania Rating Scale (YMRS) < 12
排除标准
- •History of any DSM-IV Axis I diagnosis other than BD Type I or II
- •Implanted medication pump or cardiac pacemaker;
- •Have had prior brain surgery
- •Any metal in the head (except in mouth)
- •Any disease of increased Intracranial pressure
- •Suicide attempt
- •Pharmacotherapy
- •unstable medical conditions
- •in the process of changing and redrawing withdrawing psychoactive medications within the past 4 weeks (except for sleeping medications such as benzodiazepines)
结局指标
主要结局
Changes in the MATRICS Consensus Cognitive Battery
时间窗: one weeks after the completion of the rTMS treatment)
Changes in neurocognitive and social function (measured by the The MATRICS Consensus Cognitive Battery) after 2 session of rTMS treatments (20 times)
次要结局
- relapses of depressive and/or hypo/mania episode(12 months)
研究者
Kangguang Lin
Dr.
Guangzhou Psychiatric Hospital