Virtual Reality Combined With rTMS for the Treatment of Depression : a Randomized Clinical Trial. (TMS VR)
Depression is a mood disorder affecting an individual in its entirety, altering its emotional and intellectual functioning . The major form of depression is the most common psychiatric disorder in Western countries. It is considered to be the most expensive psychiatric neurological disease in Europe and is currently treated by different methods.
However, almost a third of depressed patients shows no clinical improvement. Advances in neuroscience and understanding of neuromodulation have enabled the emergence of new treatments such as the repetitive transcranial magnetic stimulation (rTMS) . It consists of modulating the neuronal activity of a targeted brain region through a magnetic field applied by a coil. Even though this form of treatment has proven to be effective, it appears that more than half of depressed patients exhibited little to no response to it.
As brain regions targeted by TMS may also be stimulated beforehand by sensory afferent signals, it was hypothesized that optimizing the effects of TMS with virtual reality is possible through the activation of these brain regions with sensory stimuli holding emotional valence (images, sounds) while using TMS concomitantly. Based on this new research premise, the investigators propose, in the context of an open and controlled clinical trial, to use a new media entitled virtual reality for displaying interactive virtual environments with positive emotional valence ( field of flowers, green valley) to a group of depressed patients undergoing TMS at the same time.
The study will include 66 depressed patients randomly assigned into two groups : TMS and Virtual Reality Versus TMS alone. Any differences in therapeutic efficacy between the two groups will be measured by questionnaires and brain functional imagery. This innovative and therapeutic approach will allow us to better understand the appropriate processes for modulating the neuronal activity in specific brain areas for treatment purposes.
研究概览
地位
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
学习地点
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Marseille、法国、13354
- 招聘中
- Assistance Publique Hopitaux de Marseille
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接触:
- Raphaëlle RICHIERI, PH
- 电话号码:+33 491435551
- 邮箱:raphaellemarie.richieri@ap-hm.fr
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首席研究员:
- Raphaëlle RICHIERI, PH
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Criteria of resistant depression
- Age from 18 to 65 years old included.
- Primary diagnosis of major depression in subjects according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria.
- Informed consent and signed to participate in the study
Exclusion Criteria:
- Pregnant woman, parturient and nursing mothers.
- Absence of DSM-5 criteria for depression in subjects.
- Refusal to participate in the study.
- Modification of drug treatment in the month preceding inclusion.
- History of neurological pathology, head trauma or mental retardation.
- Presence of an addictive comorbidity.
- Presence of a major organic pathological.
- Presence of a contra-indication to virtual reality
- Presence of intracerebral ferro-metallic material, cochlear implant, pacemaker
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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安慰剂比较:TMS
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20 sessions navigated with Conventional Transcranial Magnetic Stimulation
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有源比较器:TMS with virtual reali
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20 sessions navigated with Conventional Transcranial Magnetic Stimulation
20 sessions navigated with virtual reality
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Evaluation of the depression score in Montgomery-asberg Depression Rating Scale (MADRS).
大体时间:36 months
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a heteroevaluation scale of depressive semiology in 10 items.
A decrease of at least 50% in initial score at the Montgomery-asberg Depression Rating Scale.
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36 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Evaluation of The State Trait Anxiety Inventory Self-Questionnaire
大体时间:36 months
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40 items with, for each, 4 modalities of response, corresponding to degrees of intensity or frequency of the habitual or general emotional state of the patient.
The calculated score varies between 20 and 80, a high score indicating the presence of anxiety.
Anxiety will be assessed before the program begins and at the end of the program.
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36 months
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合作者和调查者
调查人员
- 首席研究员:Raphaëlle RICHIERI, PH、Assistance Publique Hopitaux de Marseille
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
Transcranial Magnetic Stimulation (TMS - ) MagPro®的临床试验
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