Effects of tDCS Combined With Virtual Reality on Anxious Ruminations in Healthy Subjects With a Vulnerability to Rumination
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change in anxious ruminations after anodal tDCS and virtual reality
研究概览
简要总结
This study proposes: to evaluate 1) whether the combination of virtual reality (VR) and active tDCS provides better rumination attenuation than the combination of VR and tDCS placebo 2) the acceptability and experiential experience of combining these two well known medical devices.
详细描述
Inclusion visit:
- Confirmation of eligibility criteria
- Written informed consent
Visit 1 and 2 (or end of study visit) :
Before first ruminations induction :
- Completion of Brief State Rumination Inventory (BSRI), State-Trait Anxiety (STAI), Inventory, Visual Analogic Scale (VAS), Ruminative Response Scale - Short Form (RRS-SF), Beck depression Inventory (BDI)
- EEG recording
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Triple (Participant, Care Provider, Investigator)
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
- 是
入选标准
- •Without any particular ethnic and psychosocial criteria
- •Subject to ruminations (personality trait) documented by a RRS-SF score >30
- •Subjects with score to BDI scal <14 assessed during first visit
- •Subjects without psychiatric or addictive disorders.
- •Subjects who do not meet all the diagnostic criteria for an anxiety disorder or characterized depressive episode.
排除标准
- •contraindication to tDCS (neurosurgical history, intracranial device, skin problems)
- •current virtual reality intolerance
- •history of psychiatric or addictive disorders
- •Use of psychotropic drugs
- •Use of non psychotropic treatments significantly influencing mood or level of anxiety
- •pregnant or breast-feeding women
- •Neurological pathology, locomotor disability, or sensory (vestibular, visual, auditory ...)
研究组 & 干预措施
VR + active brain stimulation
Exposure to a virtual reality world with active transcranial electric stimulation
干预措施: VR + active brain stimulation (Device)
VR + sham brain stimulation
Exposure to a virtual reality world with sham transcranial electric stimulation
干预措施: VR +sham brain stimulation (Device)
结局指标
主要结局
Change in anxious ruminations after anodal tDCS and virtual reality
时间窗: within 1 week
Change in anxious ruminations after anodal tDCS and virtual reality will be evaluated to compare the effects of tDCS associated with virtual reality versus virtual reality alone (+ tDCS placebo) to reduce ruminations. Evaluate with Brief State Ruminative Inventory (BSRI). It is a scale with 8 items. Each item is VAS with a score ranging between 0 and 100. The total score is sum of each item score (Total /800)
次要结局
未报告次要终点