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Does Transcutaneous Vagal Nerve Stimulation Improves Fear Extinction in Humans (t-VNSext)

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ClinicalTrials.gov Identifier: NCT02113306
Recruitment Status : Unknown
Verified April 2014 by Ilse Van Diest, Universitaire Ziekenhuizen Leuven.
Recruitment status was:  Not yet recruiting
First Posted : April 14, 2014
Last Update Posted : April 14, 2014
Sponsor:
Collaborator:
KU Leuven
Information provided by (Responsible Party):
Ilse Van Diest, Universitaire Ziekenhuizen Leuven

Study Description
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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-?

Condition or disease Intervention/treatment Phase
Healthy Adults Device: t-VNS Device: sham stimulation Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: Does Transcutaneous Vagal Nerve Stimulation Improves Fear Extinction in Humans
Study Start Date : July 2014
Estimated Primary Completion Date : December 2015
Arms and Interventions
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Arm Intervention/treatment
Experimental: 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

 Device: t-VNS
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).
Other Name: NEMOS®, Cerbomed, Erlangen, Germany
Sham Comparator: 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

 Device: sham stimulation
electrodes will be put upside down
Other Name: NEMOS®, Cerbomed, Erlangen, Germany


Outcome Measures
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Primary Outcome Measures :
  1. fear response [ Time Frame: 3 test days ]
    startle blink EMG skin conductance response ECG respiration self-reports


Eligibility Criteria
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Ages Eligible for Study:   16 Years to 50 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02113306


Contacts
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Contact: Ilse Van Diest, PhD +32 16 32 60 29 ilse.vandiest@ppw.kuleuven.be

Locations
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Belgium
Faculty of Psychology and Educational Science
Leuven, Belgium, 3000
Contact: Ilse Van Diest, PhD         
Sub-Investigator: Holly Miller, PhD         
Sub-Investigator: Holly Fenlon, Ba         
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
KU Leuven
Investigators
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Principal Investigator: Ilse Van Diest, PhD KU Leuven
More Information
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Responsible Party: Ilse Van Diest, Professor, Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT02113306    
Other Study ID Numbers: t-VNS extinction
First Posted: April 14, 2014    Key Record Dates
Last Update Posted: April 14, 2014
Last Verified: April 2014