- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT03352973
Regulation of Craving in Internet Gamers
Regulation of Craving in Internet Gamers: Neural Mechanisms and tDCS Intervention
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Beijing
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Beijing, Beijing, Porcelana, 100875
- State Key Laboratory of Cognitive Neuroscience and Learning, Beijing Normal University
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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 de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Ciencia básica
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: 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.
Otros nombres:
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Comparador falso: 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.
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Craving in the regulation of craving (ROC) task after the initiation of active and sham tDCS
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Skin conductance responses (SCRs) in the ROC task after the initiation of active and sham tDCS
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Jin-Tao Zhang, PhD, Beijing Normal University
Publicaciones y enlaces útiles
Publicaciones Generales
- 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.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- IGDROC
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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