Effects of Noninvasive Brain Stimulation Techniques on BDNF Levels
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 165
- 试验地点
- 2
- 主要终点
- serum BDNF levels
研究概览
简要总结
The aim of this study is to investigate the effects of non invasive brain stimulation - NIBS - techniques (Electroconvulsivotherapy - ECT, transcranial Direct Current Stimulation - tDCS, repetitive transcranial magnetic stimulation - rTMS) on serum Brain Derived Neurotrophic factor (BDNF) levels in patients with depression and schizophrenia. Four blood samples will be collected in each participants, one before the NIBS sessions, and 3 after the completion of NIBS protocols: one immediately after the end of the NIBS sessions, a second one week after and a last one month after. Two blood samples separated by one month will also be collected in a a group of healthy volunteers.
详细描述
The hypothesis is that NIBS will modulate BDNF levels and that the modification in serum BDNF levels will be correlated with clinical improvements in the sample of patients.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •in the depression group: DSM IV criteria of MDD; HDRS17> 22; stage 2 of resistance; received rTMS or ECT
- •in the schizophrenia group DSM IV criteria of schizophrenia; pharmaco-resistance of symptoms (either negative symptoms or auditory verbal hallucination); received rTMS or tDCS
- •in the healthy volunteers group : to not have axis I of DSM IV diagnosis; no siblings with axis I DSM IV diagnosis
排除标准
- •less than 18 years old
- •pregnancy
- •received benzodiazepine
- •In the depression and schizophrenia group:
- •bipolar disorder
- •other axis I of DSM IV diagnosis (excluding for Tobacco use disorder)
研究组 & 干预措施
Depression sham repetitive transcranial magnetic stimulation
40 patients with major depression receiving a mean 4 weeks of sham 1 Hz repetitive transcranial magnetic stimulation applied over the right dorsolateral prefrontal cortex - DLPFC
干预措施: non invasive brain stimulation (Device)
Schizophrenia active transcranial Direct Current Stimulation
40 patients with schizophrenia and auditory verbal hallucinations receiving 10 sessions of transcranial Direct current stimulation (tDCS) applied with the anode over the left dorsolateral prefrontal cortex - DLPFC- and the cathode over the left temporoparietal junction
干预措施: non invasive brain stimulation (Device)
Schizophrenia sham transcranial Direct Current Stimulation
40 patients with schizophrenia and auditory verbal hallucinations receiving 10 sessions of sham transcranial Direct current stimulation (tDCS) applied with the anode over the left dorsolateral prefrontal cortex - DLPFC- and the cathode over the left temporoparietal junction
干预措施: non invasive brain stimulation (Device)
Healthy volunteers
80 healthy volunteers receiving no stimulation
Depression Electroconvulsive therapy
40 patients with major depression receiving a mean of 12 sessions of Electroconvulsive therapy
干预措施: non invasive brain stimulation (Device)
Depression active repetitive transcranial magnetic stimulation
40 patients with major depression receiving a mean 4 weeks of 1 Hz repetitive transcranial magnetic stimulation applied over the right dorsolateral prefrontal cortex - DLPFC
干预措施: non invasive brain stimulation (Device)
Schizophrenia active transcranial magnetic stimulati
40 patients with schizophrenia and predominant negative symptoms receiving 20 sessions of intermittent theta burst simulation (iTBS) applied over the left dorsolateral prefrontal cortex - DLPFC
干预措施: non invasive brain stimulation (Device)
Schizophrenia sham transcranial magnetic stimulation
patients with schizophrenia and predominant negative symptoms receiving 20 sessions of sham intermittent theta burst simulation (iTBS) applied over the left dorsolateral prefrontal cortex - DLPFC
干预措施: non invasive brain stimulation (Device)
结局指标
主要结局
serum BDNF levels
时间窗: from baseline to one month
次要结局
未报告次要终点