NCT02557815已完成3 期
Changing the Vulnerable Brain: A Neuromodulation Study in Alcohol Dependence
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 80
- 主要终点
- Change in BOLD response during an emotion regulation task (fMRI)
研究概览
简要总结
This current project investigates the effect of a single session of right dlPFC repetitive transcranial magnetic stimulation on emotion regulation abilities and craving in alcohol dependent patients and healthy controls.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 21 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Alcohol Dependence
- •Currently abstinent
排除标准
- •psychoactive medication
- •not eligible for MRI (metals or claustrophobia)
- •(familial) history of epilepsy
- •current psychiatric disorders (besides alcohol dependence)
结局指标
主要结局
Change in BOLD response during an emotion regulation task (fMRI)
时间窗: Change in BOLD response from baseline, compared to BOLD response after stimulation (approximately two weeks later)
BOLD response was measured during an emotion regulation task. The change in BOLD response between sessions is the primary outcome for this study
次要结局
- Change in experienced emotion during an emotion regulation task with Visual Analogue Scales (VAS)(Change in experienced emotion from baseline, and after the stimulation session (approximately two weeks later))
- Change in craving levels [Alcohol Urge Questionnaire (AUQ)](Before and after the emotion regulation task, during both baseline and stimulation session (e.g. 4 time points, sessions were separated by approximately two weeks))
研究者
Anneke E. Goudriaan
Prof. Dr.
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
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