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Does Transcutaneous Vagal Nerve Stimulation Improves Fear Extinction in Humans

Does Transcutaneous Vagal Nerve Stimulation Improves Fear Extinction in Humans

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02113306
Acronym
t-VNSext
Enrollment
50
Registered
2014-04-14
Start date
2014-07-31
Completion date
Unknown
Last updated
2014-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Adults

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-?

Interventions

DEVICEt-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).

DEVICEsham stimulation

electrodes will be put upside down

Sponsors

KU Leuven
CollaboratorOTHER
Universitaire Ziekenhuizen KU Leuven
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
16 Years to 50 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
fear response3 test daysstartle blink EMG skin conductance response ECG respiration self-reports

Countries

Belgium

Contacts

Primary ContactIlse Van Diest, PhD
ilse.vandiest@ppw.kuleuven.be+32 16 32 60 29

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026