Internet Gaming DisorderNCT03352973
Regulation of Craving in Internet Gamers
A study testing active tDCS on the dlPFC in people with Internet Gaming Disorder, run by Beijing Normal University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Internet Gaming Disorder
- What is being tested?
- active tDCS on the dlPFC
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 20 Jul 2018to 20 Oct 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- engagement in a popular Internet game (Arena of Valor) for over 14 hours per week for a minimum of 6 months.
Who cannot join
- current or history of use of illegal substances and gambling;
- current or history of psychiatric or neurological illness;
- current use of psychotropic medications.
Trial locations and contacts
1 site in 1 country.
China1 site
State Key Laboratory of Cognitive Neuroscience and Learning, Beijing Normal University
Beijing, Beijing Municipality, 100875
About this study
Official title: Regulation of Craving in Internet Gamers: Neural Mechanisms and tDCS Intervention
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.
Read the 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.
- Conditions
- Internet Gaming Disorder
- Being tested
- active tDCS on the dlPFC, sham tDCS on the dlPFC
- Medical subject headings
- Internet Addiction Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
active tDCS on the dlPFCOther
Also called tDCS
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.
sham tDCS on the dlPFCOther
Also called tDCS
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: Other: sham tDCS on the dlPFC |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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
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.
Measured: 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
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.
Measured: 16-17 minutes after the initiation of active and sham tDCS ham 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.
Measured: Approximately 10 minutes before the initiation of 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.
Measured: Approximately 8 minutes before the initiation of 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.
Measured: 38-40 minutes after the the initiation of 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.
Measured: 40-42 minutes after the the initiation of active and sham tDCS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2017
- Study start20 Jul 2018
- Primary completion15 Sep 2018
- Study completion20 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Internet Gaming DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- within-subject, sham-controlled design: all subjects will receive active and sham tDCS in a randomized order
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Normal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, jintao, zhang, Beijing Normal University
- Investigators
- Jin-Tao Zhang, PhD, Principal investigator, Beijing Normal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03352973
- Sponsor's protocol ID
- IGDROC
- Status last verified
- Dec 2018
- First submitted
- 13 Nov 2017
- Last updated
- 19 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 20679212Wu 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.
PubMed 33119491
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Regulation of Craving in Internet Gamers: Neural Mechanisms and tDCS Intervention
- ClinicalTrials.gov ID
- NCT03352973
- Acronym / sponsor ID
- IGDROC
- Conditions
- Internet Gaming Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Beijing Normal UniversityUniversity, hospital or other
- Study start
- 20 Jul 2018 (actual)
- Primary completion
- 15 Sep 2018 (actual)
- Study completion
- 20 Oct 2018 (actual)
- First posted
- 24 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- within-subject, sham-controlled design: all subjects will receive active and sham tDCS in a randomized order
| Arm | Type | Receives |
|---|---|---|
| active tDCS on the dlPFC | Experimental | Other: active tDCS on the dlPFCtDCS 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). |
| sham tDCS on the dlPFC | Sham comparator | Other: sham tDCS on the dlPFCEach 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. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- engagement in a popular Internet game (Arena of Valor) for over 14 hours per week for a minimum of 6 months.
Key exclusion criteria (3 listed)
- current or history of use of illegal substances and gambling;
- current or history of psychiatric or neurological illness;
- current use of psychotropic medications.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| active tDCS on the dlPFCAlso: tDCSDuring 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. | Other | active tDCS on the dlPFC |
| sham tDCS on the dlPFCAlso: tDCSDuring 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. | Other | sham tDCS on the dlPFC |
Primary outcome
Craving in the regulation of craving (ROC) task after the initiation of active and sham tDCS
Time frame: 4 minutes after the initiation of active and sham tDCS for half of the participants
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
Time frame: 16-17 minutes 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
Time frame: 45-47 minutes after the initiation of 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.
6 secondary outcomes
Skin conductance responses (SCRs) in the ROC task after the initiation of active and sham tDCS
Time frame: 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
Time frame: 16-17 minutes after the initiation of active and sham tDCS ham tDCS
Background craving before the initiation of active and sham tDCS
Time frame: Approximately 10 minutes before the initiation of active and sham tDCS
Cue-induced craving before the initiation of active and sham tDCS
Time frame: Approximately 8 minutes before the initiation of active and sham tDCS
Background craving after the initiation of active and sham tDCS
Time frame: 38-40 minutes after the the initiation of active and sham tDCS
Cue-induced craving after the initiation of active and sham tDCS
Time frame: 40-42 minutes after the the initiation of active and sham tDCS
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2018.
- Background: PubMed 20679212Kober 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.
- Derived from this study: PubMed 33119491Wu 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jin-Tao Zhang, PhD principal investigator
Beijing Normal University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing active tDCS on the dlPFC in people with Internet Gaming Disorder, run by Beijing Normal University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Craving in the regulation of craving (ROC) task after the initiation of active and sham tDCS (time frame: 4 minutes after the initiation of active and sham tDCS for half of the participants). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03352973, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2018.