- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT02113306
Does Transcutaneous Vagal Nerve Stimulation Improves Fear Extinction in Humans (t-VNSext)
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:
- accelerates extinction curves
- reduces spontaneous recovery of previously extinguished fear
- reduce re-acquisition of fear
- reduce generalization of fear to other stimuli that resemble the CS+?
- facilitates the generalization of inhibitory learning to stimuli that resemble the CS-?
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Anticipé)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Leuven, Belgique, 3000
- Faculty of Psychology and Educational Science
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Science basique
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: 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 |
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).
Autres noms:
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Comparateur factice: 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 |
electrodes will be put upside down
Autres noms:
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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fear response
Délai: 3 test days
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startle blink EMG skin conductance response ECG respiration self-reports
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3 test days
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Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Ilse Van Diest, PhD, KU Leuven
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- t-VNS extinction
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .