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Regulation of Craving in Internet Gamers

Primary Purpose

Internet Gaming Disorder

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
active tDCS on the dlPFC
sham tDCS on the dlPFC
Sponsored by
Beijing Normal University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Internet Gaming Disorder

Eligibility Criteria

18 Years - 30 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

active tDCS on the dlPFC

sham tDCS on the dlPFC

Arm Description

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).

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.

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

Skin conductance responses (SCRs) in the ROC task after the initiation of active and sham tDCS
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.
Skin conductance responses (SCRs) in the ER task after the initiation of active and sham tDCS
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.
Background craving before the initiation of active and sham tDCS
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.
Cue-induced craving before the initiation of active and sham tDCS
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.
Background craving after the initiation of active and sham tDCS
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.
Cue-induced craving after the initiation of active and sham tDCS
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.

Full Information

First Posted
November 13, 2017
Last Updated
December 17, 2018
Sponsor
Beijing Normal University
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1. Study Identification

Unique Protocol Identification Number
NCT03352973
Brief Title
Regulation of Craving in Internet Gamers
Official Title
Regulation of Craving in Internet Gamers: Neural Mechanisms and tDCS Intervention
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
July 20, 2018 (Actual)
Primary Completion Date
September 15, 2018 (Actual)
Study Completion Date
October 20, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing Normal University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Internet Gaming Disorder

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
within-subject, sham-controlled design: all subjects will receive active and sham tDCS in a randomized order
Masking
ParticipantInvestigator
Masking Description
double blind: both participants and experiment won't know the stimulation condition
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
active tDCS on the dlPFC
Arm Type
Experimental
Arm Description
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).
Arm Title
sham tDCS on the dlPFC
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
active tDCS on the dlPFC
Other Intervention Name(s)
tDCS
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
sham tDCS on the dlPFC
Other Intervention Name(s)
tDCS
Intervention Description
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.
Primary Outcome Measure Information:
Title
Craving in the regulation of craving (ROC) task after the initiation of active and sham tDCS
Description
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.
Time Frame
4 minutes after the initiation of active and sham tDCS for half of the participants
Title
Aversive feeling in the emotion regulation (ER) task after the initiation of active and sham tDCS
Description
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.
Time Frame
16-17 minutes after the initiation of active and sham tDCS
Title
Reaction times (RTs) in the cognitive task assessing inhibition of attentional bias after the initiation of active and sham tDCS
Description
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.
Time Frame
45-47 minutes after the initiation of of active and sham tDCS
Secondary Outcome Measure Information:
Title
Skin conductance responses (SCRs) in the ROC task after the initiation of active and sham tDCS
Description
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.
Time Frame
4 minutes after the initiation of active and sham tDCS
Title
Skin conductance responses (SCRs) in the ER task after the initiation of active and sham tDCS
Description
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.
Time Frame
16-17 minutes after the initiation of active and sham tDCS ham tDCS
Title
Background craving before the initiation of active and sham tDCS
Description
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.
Time Frame
Approximately 10 minutes before the initiation of active and sham tDCS
Title
Cue-induced craving before the initiation of active and sham tDCS
Description
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.
Time Frame
Approximately 8 minutes before the initiation of active and sham tDCS
Title
Background craving after the initiation of active and sham tDCS
Description
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.
Time Frame
38-40 minutes after the the initiation of active and sham tDCS
Title
Cue-induced craving after the initiation of active and sham tDCS
Description
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.
Time Frame
40-42 minutes after the the initiation of active and sham tDCS

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jin-Tao Zhang, PhD
Organizational Affiliation
Beijing Normal University
Official's Role
Principal Investigator
Facility Information:
Facility Name
State Key Laboratory of Cognitive Neuroscience and Learning, Beijing Normal University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100875
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
20679212
Citation
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.
Results Reference
background
PubMed Identifier
33119491
Citation
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.
Results Reference
derived

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Regulation of Craving in Internet Gamers

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