Does Transcutaneous Vagal Nerve Stimulation Improves Fear Extinction in Humans

Healthy Adults Clinical Trial

— t-VNSext  

Official title:

Does Transcutaneous Vagal Nerve Stimulation Improves Fear Extinction in Humans

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02113306
• Other study ID #: t-VNS extinction
• Status: Not yet recruiting
• Phase: N/A
• First received: April 10, 2014
• Last updated: April 11, 2014
• Start date: July 2014

Study information

• Verified date: April 2014
• Source: Universitaire Ziekenhuizen Leuven
• Contact: Ilse Van Diest, PhD
• Phone: +32 16 32 60 29
• Email: ilse.vandiest[@]ppw.kuleuven.be
• Is FDA regulated: No
• Health authority: Belgium: Ethics Committee
• Study type: Interventional

Clinical Trial 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-?

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 16 Years to 50 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy Adults

Intervention

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).
• sham stimulation
electrodes will be put upside down

Locations

Country	Name	City	State
Belgium	Faculty of Psychology and Educational Science	Leuven

Sponsors (2)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven	Katholieke Universiteit Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	fear response	startle blink EMG skin conductance response ECG respiration self-reports	3 test days	No