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临床试验/NCT02113306
NCT02113306Unknown不适用

Does Transcutaneous Vagal Nerve Stimulation Improves Fear Extinction in Humans

Universitaire Ziekenhuizen KU Leuven2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2014年7月最近更新:
适应症

试验速览

阶段
不适用
入组人数
50
试验地点
2
主要终点
fear response

研究概览

简要总结

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:

  1. accelerates extinction curves
  2. reduces spontaneous recovery of previously extinguished fear
  3. reduce re-acquisition of fear
  4. reduce generalization of fear to other stimuli that resemble the CS+?
  5. facilitates the generalization of inhibitory learning to stimuli that resemble the CS-?

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Single (Participant)

入排标准

年龄范围
16 Years 至 50 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • healthy men and women aged 16 - 50 years

排除标准

  • 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

结局指标

主要结局

fear response

时间窗: 3 test days

startle blink EMG skin conductance response ECG respiration self-reports

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ilse Van Diest

Professor

Universitaire Ziekenhuizen KU Leuven

研究点 (2)

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