The Comparison of Effectiveness of Bilateral rTMS Versus Unilateral TMS in Patients With Bipolar Depression: a Study Randomized and Single Blind
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Change in depression severity.Depression will be assessed using the Beck depression inventory
研究概览
简要总结
The aim of this study is to investigate the effect of repetitive TMS in reduction of depressive symptoms in patients with bipolar disorder. In a randomized, single blind clinical trials, 30 patients with bipolar disorder in Atieh Neuroscience center will be assigned to receive bilateral TMS and unilateral TMS, daily; for 20 sessions. The depressive and anxiety symptoms and quality of life will be assessed before the treatment (pre test) during the treatment (10th session), and after the treatment (post test). QEEG apply before and after rTMS in all subjects.
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
- Single (Outcomes Assessor)
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
- •Outpatients male and female with the range of 18-65 years of age
- •The diagnosis of Bipolar disorder according to DSM-IV-TR
- •Completion of consent form
- •Being under supervision of a psychiatrist,
- •Having BDI>14
- •Being able to adhere to treatment schedule,
- •Having stable symptoms as defined by not requiring a change in medication for at least 4 weeks .
排除标准
- •The history of rTMS treatment for any reason
- •Intracranial implant and other ferromagnetic materials close to the head
- •Cardiac pacemaker
- •The risk of seizure with any reasons
- •High intracranial pressure
- •The history of epilepsy or seizure in the first relatives
- •Any metal in head
- •Breastfeeding
- •High risk of suicide 12 Having personality disorder in axis II
结局指标
主要结局
Change in depression severity.Depression will be assessed using the Beck depression inventory
时间窗: Baseline to four weeks
The BDI-II is measured depressive symptoms is administered before treatment, session 10, immediately after treatment.
次要结局
- Change in World Health Organization Quality of Life- BREF (WHOQOL-BREF)(Test Day 1, 10& 20)
- Change in QEEG and low resolution brain electromagnetic tomography (LORETA)(Before treatment, immediately after treatment)
- Change in anxiety severity .Anxiety will be assessed using the Beck Anxiety inventory.(Test Day 1, 10 & 20)
研究者
reza kazemi
Researcher
The Neuroscience Center, LLC