NCT03352973

Brief Summary

This project aims to investigate (1) the behavioral and neural mechanisms of regulation of craving in Internet gamers; (2) effects of tDCS over the dorsal lateral prefrontal cortex (dlPFC) on craving and regulation of craving and aversive emotions in this population. (3) effects of tDCS over dlPFC on attentional bias towards gaming related cues.This project will be conducted in Beijing, China, based on a large sample of Internet gamers.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 13, 2017

Completed
11 days until next milestone

First Posted

Study publicly available on registry

November 24, 2017

Completed
8 months until next milestone

Study Start

First participant enrolled

July 20, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 20, 2018

Completed
Last Updated

December 19, 2018

Status Verified

December 1, 2018

Enrollment Period

2 months

First QC Date

November 13, 2017

Last Update Submit

December 17, 2018

Conditions

Outcome Measures

Primary Outcomes (3)

  • Craving in the regulation of craving (ROC) task after the initiation of active and sham tDCS

    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.

    4 minutes after the initiation of active and sham tDCS for half of the participants

  • Aversive feeling in the emotion regulation (ER) task after the initiation of active and sham tDCS

    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.

    16-17 minutes after the initiation of active and sham tDCS

  • Reaction times (RTs) in the cognitive task assessing inhibition of attentional bias after the initiation of active and sham tDCS

    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.

    45-47 minutes after the initiation of of active and sham tDCS

Secondary Outcomes (6)

  • Skin conductance responses (SCRs) in the ROC task after the initiation of active and sham tDCS

    4 minutes after the initiation of active and sham tDCS

  • Skin conductance responses (SCRs) in the ER task after the initiation of active and sham tDCS

    16-17 minutes after the initiation of active and sham tDCS ham tDCS

  • Background craving before the initiation of active and sham tDCS

    Approximately 10 minutes before the initiation of active and sham tDCS

  • Cue-induced craving before the initiation of active and sham tDCS

    Approximately 8 minutes before the initiation of active and sham tDCS

  • Background craving after the initiation of active and sham tDCS

    38-40 minutes after the the initiation of active and sham tDCS

  • +1 more secondary outcomes

Study Arms (2)

active tDCS on the dlPFC

EXPERIMENTAL

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).

Other: active tDCS on the dlPFC

sham tDCS on the dlPFC

SHAM COMPARATOR

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.

Other: sham tDCS on the dlPFC

Interventions

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.

Also known as: tDCS
active tDCS on the dlPFC

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.

Also known as: tDCS
sham tDCS on the dlPFC

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • engagement in a popular Internet game (Arena of Valor) for over 14 hours per week for a minimum of 6 months.

You may not qualify if:

  • current or history of use of illegal substances and gambling;
  • current or history of psychiatric or neurological illness;
  • current use of psychotropic medications.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

State Key Laboratory of Cognitive Neuroscience and Learning, Beijing Normal University

Beijing, Beijing Municipality, 100875, China

Location

Related Publications (2)

  • 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.

    PMID: 20679212BACKGROUND
  • 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.

MeSH Terms

Conditions

Internet Addiction Disorder

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Technology AddictionBehavior, AddictiveCompulsive BehaviorImpulsive BehaviorBehavior

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

Study Officials

  • Jin-Tao Zhang, PhD

    Beijing Normal University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
double blind: both participants and experiment won't know the stimulation condition
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: within-subject, sham-controlled design: all subjects will receive active and sham tDCS in a randomized order
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associated Professor

Study Record Dates

First Submitted

November 13, 2017

First Posted

November 24, 2017

Study Start

July 20, 2018

Primary Completion

September 15, 2018

Study Completion

October 20, 2018

Last Updated

December 19, 2018

Record last verified: 2018-12

Locations