Assessment of the Neuronavigation System Coupled With Repetitive Transcranial Magnetic Stimulation. A Randomized Double Blind Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 107
- 试验地点
- 10
- 主要终点
- Response
研究概览
简要总结
Repetitive Transcranial Magnetic Stimulation (rTMS) is a non invasive technique which was shown to be effective in the treatment of major depression.
The dorsolateral prefrontal cortex (DLPFC) is the anatomic target in rTMS studies and the standard (manual) '5-cm method' for positioning the coil over DLPFC is the reference. Nevertheless, it has been criticized due to poor targeting accuracies attributed to inter-subject variability.
Such an inaccuracy could have any therapeutic consequences as a decrease in rTMS efficacy.
Preliminary findings suggest that a more reproductible and accurate method, based upon a neuronavigation system could allow for a better efficacy. This finding has to be replicated with sound methodology.
Investigator's objective is to compare efficacy on mood of coil positioning based upon a neuronavigation device versus coil positioning based upon the standard method.
详细描述
Background :
Repetitive Transcranial Magnetic Stimulation (rTMS) is a new tool for major depressive disorder.
rTMS is a non invasive technique allowing for a localized stimulation of cerebral tissue cortex. rTMS uses electromagnetic induction to induce weak electric currents using a rapidly changing magnetic field; this can modify activity in specific or general parts of the brain.
Meta-analyses have stated that rTMS appeared to be effective in the treatment of major depression despite any limits concerning sample sizes and methodological concerns.
Studies have shown that this technique potentiates antidepressants treatment in combination therapy.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients giving their consent;
- •Right handed;
- •Age > 18 and < 65;
- •With a DSM-IV diagnosis of MDD, single episode or recurrent;
- •With an antidepressant treatment unchanged in the 3 last weeks;
- •With an MADRS score ≥ 21;
- •Benzodiazepine treatments have to be avoided;
排除标准
- •Major depressive episode with psychotic characteristics;
- •A lifetime of the following axis 1 diagnoses: schizophrenia or substance use disorder (alcohol or other substance);
- •Stade 5 of Thase and Rush classification ;
- •Involuntary hospitalizations;
- •Patients under guardianship;
- •Outpatients in case of an increased risk of suicide as assessed by a MADRS item 10 > 3;
- •Contraindication for MRI or rTMS: a personal history of a seizure disorder, presence of neurologic or neurosurgical disorder, presence of ferromagnetic material (including intraocular) or metallic medical devices (pacemakers);
- •Pregnancy.
研究组 & 干预措施
Neuronavigation system
10 sessions of rTMS coupled with a neuronavigation system
Description of 1 session of the rTMS protocol :
- Frequency: 20Hz
- Intensity: 110% of motor threshold
- 80 train of 2 seconds duration
- 10 seconds between two trains
- 3200 pulses
Devices :
- rTMS: System Mag Pro (Magventure, Denmark)
- Neuronavigation system: Syneika One (Syneika, France)
干预措施: Neuronavigation system (Device)
Standard localisation method
10 sessions of rTMS with manual localisation of the DLPFC using the standard localisation method (i.e. the '5-cm method')
Description of 1 session of the rTMS protocol :
- Frequency: 20Hz
- Intensity: 110% of motor threshold
- 80 train of 2 seconds duration
- 10 seconds between two trains
- 3200 pulses
Devices :
- rTMS: System Mag Pro (Magventure, Denmark)
干预措施: Standard localisation method (Device)
结局指标
主要结局
Response
时间窗: Day 44
Response defined as at least 50% reduction in the MADRS score.
次要结局
- BDI(Day 0 Day 14 Day 14)
- ERD(Day 0 Day 14 day 44)
- Response(Day 14)
- Remission(Day 14 Day 44)
- MADRS(Day 0, day 14 and day 44)