- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT03352973
Regulation of Craving in Internet Gamers
Regulation of Craving in Internet Gamers: Neural Mechanisms and tDCS Intervention
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
As with the experiment about tDCS effects on regulation of craving and aversive emotions, the experiment aims to test whether tDCS over dlPFC will enhance cognitive regulation of craving and aversive emotions. It is a within-subject, sham-controlled, double-blind design. Each participant receive both active and sham tDCS of dlPFC in a randomized order separated by one week. During both active and sham tDCS sessions, participants will perform regulation of craving (ROC) and emotion regulation (ER) tasks. In the ROC task, participants will be asked to downregulate and upregulate craving elicited by gaming pictures using cognitive reappraisal. In the ER task, participants will be asked to downregulate and upregulate aversive feelings elicited by negative pictures using cognitive reappraisal. During these tasks, self-report ratings and skin conductance responses (SCRs) will be recorded. The cognitive regulation ability is indexed by rating and SCRs differences between the up- and downregulation conditions.
As with the experiment about tDCS effects on attentional bias, the experiment aims to test whether tDCS over dlPFC will enhance inhibitory control of attentional bias towards gaming related cues. The inhibitory control of attentional bias will be measured by a cognitive task in which participants will perform a number classification task with gaming pictures and non-gaming pictures being distractors. The experiment is a within-subject, sham-controlled, double-blind design. Each participant will receive both active and sham tDCS of dlPFC in a randomized order separated by one week. After each tDCS session, participants will complete the cognitive task assessing inhibitory control of attentional bias. During the task, reaction times (RTs) wil be recorded. The attentional bias is indexed by RTs differences between trials with gaming pictures and trials with non-gaming pictures.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Beijing
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Beijing, Beijing, Chine, 100875
- State Key Laboratory of Cognitive Neuroscience and Learning, Beijing Normal University
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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:
- engagement in a popular Internet game (Arena of Valor) for over 14 hours per week for a minimum of 6 months.
Exclusion Criteria:
- current or history of use of illegal substances and gambling;
- current or history of psychiatric or neurological illness;
- current use of psychotropic medications.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Science basique
- Répartition: Randomisé
- Modèle interventionnel: Affectation croisée
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: active tDCS on the dlPFC
tDCS on the DLPFC Dorsolateral prefrontal cortex (DLPFC) target will be identified by the baseline functional magnetic resonance imaging (fMRI) study for regulation of craving using a separate sample.
During the intervention, each participant will receive an active transcranial direct current stimulation (tDCS) intervention on this DLPFC region (1.5 mA for 20 minutes).
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During active tDCS session, participants will perform the regulation of craving (ROC) and emotion regulation (ER) tasks.
In the ROC task, participants will downregulate and upregulate craving elicited by gaming pictures using cognitive reappraisal.
In the ER task, participants will downregulate and upregulate aversive feelings by negative pictures using cognitive reappraisal.
After the active tDCS session, participants will complete a cognitive task assessing inhibitory control of attentional bias, in which participants will perform a number classification task with gaming pictures and non-gaming pictures being distractors.
During the task, reaction times (RTs) wil be recorded.
Autres noms:
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Comparateur factice: sham tDCS on the dlPFC
Each participant will also receive a sham tDCS intervention as a controlled condition.
The sham tDCS only include a 30-s ramp up and a 30-s ramp down.
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During the sham tDCS session, participants will perform the regulation of craving (ROC) and emotion regulation (ER) tasks.
In the ROC task, participants will downregulate and upregulate craving elicited by gaming pictures using cognitive reappraisal.
In the ER task, participants will downregulate and upregulate aversive feelings by negative pictures using cognitive reappraisal.
After the sham tDCS session, participants will complete a cognitive task assessing inhibitory control of attentional bias, in which participants will perform a number classification task with gaming pictures and non-gaming pictures being distractors.
During the task, reaction times (RTs) wil be recorded.
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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Craving in the regulation of craving (ROC) task after the initiation of active and sham tDCS
Délai: 4 minutes after the initiation of active and sham tDCS for half of the participants
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Using the Visual Analog Scale (from 1 = 'not at all' to 9 = 'very much'), craving is assessed in the ROC task.
This task lasts 12-13 minutes.
Craving in the downregulation condition will be compared between the active and sham tDCS.
Craving in the upregulation condition will also be compared between the active and sham tDCS.
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4 minutes after the initiation of active and sham tDCS for half of the participants
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Aversive feeling in the emotion regulation (ER) task after the initiation of active and sham tDCS
Délai: 16-17 minutes after the initiation of active and sham tDCS
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Using the Visual Analog Scale (from 1 = 'not at all' to 9 = 'very much'), aversive feeling is assessed in the ER task.
This task lasts 12-13 minutes.
Aversive feeling in the downregulation condition will be compared between the active and sham tDCS.
Aversive feeling in the upregulation condition will also be compared between the active and sham tDCS.
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16-17 minutes after the initiation of active and sham tDCS
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Reaction times (RTs) in the cognitive task assessing inhibition of attentional bias after the initiation of active and sham tDCS
Délai: 45-47 minutes after the initiation of of active and sham tDCS
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Using the E-prime software, RTs are recorded in milliseconds in the cognitive task assessing inhibition of attentional bias.
The cognitive task lasts 5-6 minutes.
RTs difference between the trials including gaming pictures and those including gaming pictures will be calculated and such RTs difference will be compared between the active and sham tDCS.
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45-47 minutes after the initiation of of active and sham tDCS
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
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Skin conductance responses (SCRs) in the ROC task after the initiation of active and sham tDCS
Délai: 4 minutes after the initiation of active and sham tDCS
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Using a biosignal recorder, SCRs are recorded in μs in the ROC task.
This task lasts 12-13 minutes.
SCRs in the downregulation condition will be compared between the active and sham tDCS.
SCRs in the upregulation condition will also be compared between the active and sham tDCS.
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4 minutes after the initiation of active and sham tDCS
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Skin conductance responses (SCRs) in the ER task after the initiation of active and sham tDCS
Délai: 16-17 minutes after the initiation of active and sham tDCS ham tDCS
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Using a biosignal recorder, SCRs are recorded in μs in the ER task.
This task lasts 12-13 minutes.
SCRs in the downregulation condition will be compared between the active and sham tDCS.
SCRs in the upregulation condition will also be compared between the active and sham tDCS.
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16-17 minutes after the initiation of active and sham tDCS ham tDCS
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Background craving before the initiation of active and sham tDCS
Délai: Approximately 10 minutes before the initiation of active and sham tDCS
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Using the Visual Analog Scale (from 1 = 'not at all' to 9 = 'very much'), background craving is assessed with a one-item questionaire (how much do you crave playing internet games now?).
This assessment lasts approximately 1 minute.
Background craving will be compared between the active and sham tDCS.
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Approximately 10 minutes before the initiation of active and sham tDCS
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Cue-induced craving before the initiation of active and sham tDCS
Délai: Approximately 8 minutes before the initiation of active and sham tDCS
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Using the Visual Analog Scale (from 1 = 'not at all' to 9 = 'very much'), cue-induced craving is assessed in a cue-reactivity task.
This assessment lasts 1-2 minutes.
Cue-induced craving will be compared between the active and sham tDCS.
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Approximately 8 minutes before the initiation of active and sham tDCS
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Background craving after the initiation of active and sham tDCS
Délai: 38-40 minutes after the the initiation of active and sham tDCS
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Using the Visual Analog Scale (from 1 = 'not at all' to 9 = 'very much'), background craving is assessed with a one-item questionaire (how much do you crave playing internet games now?).
This assessment lasts approximately 1 minute.
Background craving will be compared between the active and sham tDCS.
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38-40 minutes after the the initiation of active and sham tDCS
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Cue-induced craving after the initiation of active and sham tDCS
Délai: 40-42 minutes after the the initiation of active and sham tDCS
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Using the Visual Analog Scale (from 1 = 'not at all' to 9 = 'very much'), cue-induced craving is assessed in a cue-reactivity task.
This assessment lasts 1-2 minutes.
Cue-induced craving will be compared between the active and sham tDCS.
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40-42 minutes after the the initiation of active and sham tDCS
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Jin-Tao Zhang, PhD, Beijing Normal University
Publications et liens utiles
Publications générales
- Kober H, Mende-Siedlecki P, Kross EF, Weber J, Mischel W, Hart CL, Ochsner KN. Prefrontal-striatal pathway underlies cognitive regulation of craving. Proc Natl Acad Sci U S A. 2010 Aug 17;107(33):14811-6. doi: 10.1073/pnas.1007779107. Epub 2010 Aug 2.
- Wu LL, Potenza MN, Zhou N, Kober H, Shi XH, Yip SW, Xu JH, Zhu L, Wang R, Liu GQ, Zhang JT. Efficacy of single-session transcranial direct current stimulation on addiction-related inhibitory control and craving: a randomized trial in males with Internet gaming disorder. J Psychiatry Neurosci. 2021 Jan 4;46(1):E111-E118. doi: 10.1503/jpn.190137.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
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
- IGDROC
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
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