Does Transcutaneous Vagal Nerve Stimulation Improves Fear Extinction in Humans (t-VNSext)
A recent study with rats showed that electrical stimulation of the vagus nerve (VNS) facilitates extinction of fear (Pena, Engineer, & McIntyre, Biological Psychiatry, 2013). The hypothesized mechanism is that VNS both enhances memory consolidation (by increasing noradrenergic neurotransmission) and reduces anxiety (thus: preventing fear responses to the CS which may re-consolidate the fear memory). The effect was only apparent when VNS occurred during exposure of the fear conditioned stimulus (CS), and not when stimulation was given immediately following exposure. These results may have implications for the treatment of anxiety disorders in humans. However, until recently, the only means to investigate the effects of VNS on human fear learning would have required the invasive implantation of vagus nerve stimulators. This has fortunately changed, as a non-invasive transcutaneous VNS device has been approved for use in the E.U. for the treatment of psychological disorders.
This study proposes to use a t-VNS to investigate its effects on fear learning and extinction in (healthy) humans. Previous research has only investigated the effects it has on human mood and memory. The results obtained suggest that it reduces negative affect and enhances memory, findings which are consistent with those reported for rats. It is thus reasonable to expect that t-VNS will facilitate the extinction of fear in humans.
The present study aims to answer the following research questions:
Does t-VNS during extinction training:
- accelerates extinction curves
- reduces spontaneous recovery of previously extinguished fear
- reduce re-acquisition of fear
- reduce generalization of fear to other stimuli that resemble the CS+?
- facilitates the generalization of inhibitory learning to stimuli that resemble the CS-?
研究概览
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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Leuven、比利时、3000
- Faculty of Psychology and Educational Science
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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:
- healthy men and women aged 16 - 50 years
Exclusion Criteria:
- current or past psychiatric or neurological disorder
- use of psychopharmaca
- use of medication that affects autonomic nervous functioning (e.g., bèta-blockers)
- current cardiac or respiratory disorder
- pregnancy
学习计划
研究是如何设计的?
设计细节
- 主要用途:基础科学
- 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 |
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实验性的:t-VNS
electrical stimulation of the concha of the ear 30sec trains of 0.25msec-duration monophasic square wave pulses at 25Hz, with a stimulation intensity not exceeding 0.5 mA |
The device that will be used is approved for systematic use by those with epilepsy and depression in the European Union.
It has been used in studies of acute stimulation with healthy participants with no significant changes in heart rate or breathing (Kraus et al., 2007; Busch et al., 2013).
其他名称:
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假比较器:sham t-VNS
Sham stimulation of the earlobe will be conducted by positioning the electrode upside down 30sec trains of 0.25msec-duration monophasic square wave pulses at 25Hz, with a stimulation intensity not exceeding 0.5 mA |
electrodes will be put upside down
其他名称:
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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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fear response
大体时间:3 test days
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startle blink EMG skin conductance response ECG respiration self-reports
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3 test days
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合作者和调查者
研究记录日期
研究主要日期
学习开始
初级完成 (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 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- t-VNS extinction
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t-VNS的临床试验
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Tallaght University Hospital招聘中
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cerbomed GmbHInstitut fuer anwendungsorientierte Forschung und klinische Studien GmbH完全的
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The University of Texas Health Science Center,...MicroTransponder Inc.招聘中
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MicroTransponder Inc.National Institute on Deafness and Other Communication Disorders (NIDCD)完全的
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University of LouisvilleNational Institute of General Medical Sciences (NIGMS)招聘中