Virtual Reality Combined With rTMS for the Treatment of Depression : a Randomized Clinical Trial.
试验速览
- 阶段
- 不适用
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Evaluation of the depression score in Montgomery-asberg Depression Rating Scale (MADRS).
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •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
排除标准
- •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
研究组 & 干预措施
TMS
干预措施: Transcranial Magnetic Stimulation (TMS - ) MagPro® (Device)
TMS with virtual reali
干预措施: Transcranial Magnetic Stimulation (TMS - ) MagPro® (Device)
TMS with virtual reali
干预措施: virtual reality for displaying interactive virtual environments (Device)
结局指标
主要结局
Evaluation of the depression score in Montgomery-asberg Depression Rating Scale (MADRS).
时间窗: 36 months
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.
次要结局
- Evaluation of The State Trait Anxiety Inventory Self-Questionnaire(36 months)