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Clinical Trials/NCT02113306
NCT02113306
Unknown
Not Applicable

Does Transcutaneous Vagal Nerve Stimulation Improves Fear Extinction in Humans

Universitaire Ziekenhuizen KU Leuven1 site in 1 country50 target enrollmentJuly 2014
ConditionsHealthy Adults

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Healthy Adults
Sponsor
Universitaire Ziekenhuizen KU Leuven
Enrollment
50
Locations
1
Primary Endpoint
fear response
Last Updated
12 years ago

Overview

Brief Summary

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-?
Registry
clinicaltrials.gov
Start Date
July 2014
End Date
December 2015
Last Updated
12 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ilse Van Diest

Professor

Universitaire Ziekenhuizen KU Leuven

Eligibility Criteria

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

Outcomes

Primary Outcomes

fear response

Time Frame: 3 test days

startle blink EMG skin conductance response ECG respiration self-reports

Study Sites (1)

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