- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT03336788
Virtual Reality Combined With rTMS for the Treatment of Depression : a Randomized Clinical Trial. (TMS VR)
Depression is a mood disorder affecting an individual in its entirety, altering its emotional and intellectual functioning . The major form of depression is the most common psychiatric disorder in Western countries. It is considered to be the most expensive psychiatric neurological disease in Europe and is currently treated by different methods.
However, almost a third of depressed patients shows no clinical improvement. Advances in neuroscience and understanding of neuromodulation have enabled the emergence of new treatments such as the repetitive transcranial magnetic stimulation (rTMS) . It consists of modulating the neuronal activity of a targeted brain region through a magnetic field applied by a coil. Even though this form of treatment has proven to be effective, it appears that more than half of depressed patients exhibited little to no response to it.
As brain regions targeted by TMS may also be stimulated beforehand by sensory afferent signals, it was hypothesized that optimizing the effects of TMS with virtual reality is possible through the activation of these brain regions with sensory stimuli holding emotional valence (images, sounds) while using TMS concomitantly. Based on this new research premise, the investigators propose, in the context of an open and controlled clinical trial, to use a new media entitled virtual reality for displaying interactive virtual environments with positive emotional valence ( field of flowers, green valley) to a group of depressed patients undergoing TMS at the same time.
The study will include 66 depressed patients randomly assigned into two groups : TMS and Virtual Reality Versus TMS alone. Any differences in therapeutic efficacy between the two groups will be measured by questionnaires and brain functional imagery. This innovative and therapeutic approach will allow us to better understand the appropriate processes for modulating the neuronal activity in specific brain areas for treatment purposes.
Aperçu de l'étude
Statut
Les conditions
Type d'étude
Inscription (Anticipé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Raphaëlle RICHIERI, PH
- Numéro de téléphone: +33 491435551
- E-mail: raphaellemarie.richieri@ap-hm.fr
Lieux d'étude
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Marseille, France, 13354
- Recrutement
- Assistance Publique Hopitaux de Marseille
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Contact:
- Raphaëlle RICHIERI, PH
- Numéro de téléphone: +33 491435551
- E-mail: raphaellemarie.richieri@ap-hm.fr
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Chercheur principal:
- Raphaëlle RICHIERI, PH
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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:
- Criteria of resistant depression
- Age from 18 to 65 years old included.
- Primary diagnosis of major depression in subjects according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria.
- Informed consent and signed to participate in the study
Exclusion Criteria:
- Pregnant woman, parturient and nursing mothers.
- Absence of DSM-5 criteria for depression in subjects.
- Refusal to participate in the study.
- Modification of drug treatment in the month preceding inclusion.
- History of neurological pathology, head trauma or mental retardation.
- Presence of an addictive comorbidity.
- Presence of a major organic pathological.
- Presence of a contra-indication to virtual reality
- Presence of intracerebral ferro-metallic material, cochlear implant, pacemaker
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Comparateur placebo: TMS
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20 sessions navigated with Conventional Transcranial Magnetic Stimulation
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Comparateur actif: TMS with virtual reali
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20 sessions navigated with Conventional Transcranial Magnetic Stimulation
20 sessions navigated with virtual reality
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Evaluation of the depression score in Montgomery-asberg Depression Rating Scale (MADRS).
Délai: 36 months
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a heteroevaluation scale of depressive semiology in 10 items.
A decrease of at least 50% in initial score at the Montgomery-asberg Depression Rating Scale.
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36 months
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Evaluation of The State Trait Anxiety Inventory Self-Questionnaire
Délai: 36 months
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40 items with, for each, 4 modalities of response, corresponding to degrees of intensity or frequency of the habitual or general emotional state of the patient.
The calculated score varies between 20 and 80, a high score indicating the presence of anxiety.
Anxiety will be assessed before the program begins and at the end of the program.
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36 months
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Collaborateurs et enquêteurs
Les enquêteurs
- Chercheur principal: Raphaëlle RICHIERI, PH, Assistance Publique Hopitaux de Marseille
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 2016-21
- 2016-A01115-46 (Identificateur de registre: ID RCB)
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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 .
Essais cliniques sur Transcranial Magnetic Stimulation (TMS - ) MagPro®
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University Hospital, GrenobleComplétéVolontaires en bonne santéFrance
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Wuerzburg University HospitalUniversity of WuerzburgComplété
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Assistance Publique Hopitaux De MarseilleComplété