Efficacy of Intermittent ThetaBurst Stimulation Compared to 10 Hz Stimulation on Dorsolateral Prefrontal Cortex in Treatment Resistant Major Depressive Disorder: a Double-blind Randomized Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Therapeutic response rate
研究概览
简要总结
This trial will compare innovating stimulation parameters, intermittent Theta Burst Stimulation, to the standard high frequency stimulation protocol. The Left dorsolateral prefrontal cortex, targeted by MRI navigation will be the site of stimulation in both treatment conditions. The study seeks to determine if there is a superiority in therapeutic efficacy with iTBS protocol compared to conventional one.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years to 75 years
- •Both gender eligible
- •Volontary and able to give consent
- •Major depressive episode (MADRS > 20) single or recurrent
- •Resistance to at least 2 antidepressants ,
- •Treated by antidepressant at efficient stable posology since more than 6 weeks
排除标准
- •Initiation or modification of antidepressant drug
- •Neurodegenerative diseas
- •Bipolar I, II disorder
- •Schizophrenia, schizoaffective disorder, schizophreniform, delusional disorder, or current psychotic symptoms
- •Substance abuse in past 15 days
- •Substance dependence not weaned
- •Benzodiazepine and any anticonvulsant during rTMS treatment course
- •ECT failure in medical history
- •Contra-indication to rTMS and MRI
- •Pregnancy
- •Difficulty to obtain informed consent
研究组 & 干预措施
High Frequency Left repetitive
High Frequency Left repetitive transcranial magnetic stimulation five days per week for 4 weeks Magventure Cool B65 Coil with Magpro X100
干预措施: Transcranial magnetic stimulation (Device)
intermittent Theta Burst Stimulation (iTBS)
intermittent Theta Burst Stimulation (iTBS) five days per week for 4 weeks Magventure Cool B65 Coil with Magpro X100
干预措施: Transcranial magnetic stimulation (Device)
结局指标
主要结局
Therapeutic response rate
时间窗: 6 months
Primary outcome will be therapeutic response rate corresponding to with MADRS score improvement \> 50 % in each group at the end of TMS sessions and one month after. A final score of \<8 is categorized as remission.
次要结局
- Relapse rate(6 months)
- Quality of life(6 months)
- Measures of cortical excitability(6 months)