Changing the Vulnerable Brain: A Neuromodulation Study in Alcohol Dependence
2015年9月22日 更新者:Anneke E. Goudriaan、Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
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.
研究概览
研究类型
介入性
注册 (实际的)
80
阶段
- 第三阶段
参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
21年 至 60年 (成人)
接受健康志愿者
是的
有资格学习的性别
全部
描述
Inclusion Criteria:
- Alcohol Dependence
- Currently abstinent
Exclusion Criteria:
- psychoactive medication
- not eligible for MRI (metals or claustrophobia)
- (familial) history of epilepsy
- current psychiatric disorders (besides alcohol dependence)
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
实验性的:Active Repetitive Transcranial Magnetic Stimulation (rTMS)
Repetitive Transcranial Magnetic Stimulation: Active 10hz stimulation over the right dorsolateral Prefrontal Cortex (dlPFC)
|
Repetitive 10Hz right DLPFC stimulation using Magstim TMS apparatus
|
假比较器:Sham stimulation
Repetitive Transcranial Magnetic Stimulation: sham stimulation over the right dlPFC
|
Repetitive 10Hz right DLPFC stimulation using Magstim TMS apparatus
|
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 |
---|---|---|
Change in BOLD response during an emotion regulation task (fMRI)
大体时间: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
|
Change in BOLD response from baseline, compared to BOLD response after stimulation (approximately two weeks later)
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Change in experienced emotion during an emotion regulation task with Visual Analogue Scales (VAS)
大体时间:Change in experienced emotion from baseline, and after the stimulation session (approximately two weeks later)
|
Participants were instructed to either 'attend' or 'regulate' their emotion associated with the presented (negatively valenced) pictures.
Experienced (or regulated) emotion was assessed 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)]
大体时间: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)
|
The AUQ was administered in order to assess craving levels.
The AUQ consists of eight statements wich are rated on a 7 point likert scale [0 = Strongly disagree, 6 = Strongly Agree]
|
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)
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员:Anneke E Goudriaan, Prof dr.、Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Jansen JM, van Holst RJ, van den Brink W, Veltman DJ, Caan MW, Goudriaan AE. Brain function during cognitive flexibility and white matter integrity in alcohol-dependent patients, problematic drinkers and healthy controls. Addict Biol. 2015 Sep;20(5):979-89. doi: 10.1111/adb.12199. Epub 2014 Dec 5.
- Jansen JM, Daams JG, Koeter MW, Veltman DJ, van den Brink W, Goudriaan AE. Effects of non-invasive neurostimulation on craving: a meta-analysis. Neurosci Biobehav Rev. 2013 Dec;37(10 Pt 2):2472-80. doi: 10.1016/j.neubiorev.2013.07.009. Epub 2013 Jul 31.
- Jansen JM, van den Heuvel OA, van der Werf YD, de Wit SJ, Veltman DJ, van den Brink W, Goudriaan AE. The Effect of High-Frequency Repetitive Transcranial Magnetic Stimulation on Emotion Processing, Reappraisal, and Craving in Alcohol Use Disorder Patients and Healthy Controls: A Functional Magnetic Resonance Imaging Study. Front Psychiatry. 2019 May 7;10:272. doi: 10.3389/fpsyt.2019.00272. eCollection 2019.
- Jansen JM, van den Heuvel OA, van der Werf YD, de Wit SJ, Veltman DJ, van den Brink W, Goudriaan AE. Emotion Processing, Reappraisal, and Craving in Alcohol Dependence: A Functional Magnetic Resonance Imaging Study. Front Psychiatry. 2019 Apr 9;10:227. doi: 10.3389/fpsyt.2019.00227. eCollection 2019.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2012年2月1日
初级完成 (实际的)
2014年10月1日
研究注册日期
首次提交
2015年9月6日
首先提交符合 QC 标准的
2015年9月22日
首次发布 (估计)
2015年9月23日
研究记录更新
最后更新发布 (估计)
2015年9月23日
上次提交的符合 QC 标准的更新
2015年9月22日
最后验证
2015年9月1日
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.