Internet Gaming DisorderNCT06634498
The Effect of Repetitive Transcranial Magnetic Stimulation for Internet Gaming Disorder
A study testing real rTMS on the dlPFC in people with Internet Gaming Disorder, run by Jin-tao Zhang at 2 sites in China.
Trial summary
This study aims to investigate the intervention effects of navigated repetitive transcranial magnetic stimulation (rTMS) on craving regulation in individuals with internet gaming disorder (IGD). 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?
- real rTMS on the dlPFC
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 2 sitesChina
- Study dates
- 10 Oct 2024to 30 Jun 2025
- 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
- DSM-V gaming disorder >5 and scored ≥ 50 on a revised version of Young's online Internet addiction test；
- spent more than 50% of their online time gaming；
- engagement in one of four popular Internet game (Arena of Valor,Genshine, LOL, FPS) for over 20 hours per week for at least 1 year.
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;
- cognitive impairment as assessed by the Mini-International Neuropsychiatric Interview；
- surgery, head trauma or heart related diseases in the past year；
- a history of epilepsy or seizures or increased risk of seizures for any reason；
- metal implants or tattoos of the neck or head；
- claustrophobia.
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
State Key Laboratory of Cognitive Neuroscience and Learning
Beijing
Jin-Tao Zhang, Phd, zhangjintao@bnu.edu.cn
- Recruiting
Medical Ethics Committee of Zhenjiang Mental Health Center
Zhenjiang, Jiangsu
Zi-Liang Wang, Phd, 18395949625, wangziliang201@163.com
About this study
Official title: The Effect of Repetitive Transcranial Magnetic Stimulation of the Left Dorsolateral Prefrontal Cortex in Internet Gaming Disorder
This study aims to investigate the intervention effects of navigated repetitive transcranial magnetic stimulation (rTMS) on craving regulation in individuals with internet gaming disorder (IGD). The primary objectives include: (1) examining the impact of navigated rTMS over the dorsolateral prefrontal cortex (DLPFC) on the gaming cravings, and craving regulation capacity; and (2) exploring the potential neural mechanisms by which rTMS over the DLPFC improves craving intensity, and craving regulation ability.
Read the detailed description
Repetitive transcranial magnetic stimulation (rTMS) has been shown to reduce cravings in individuals with substance addiction. However, to date, no studies have systematically examined the short-term and long-term clinical and cognitive effects of sustained rTMS treatment on internet gaming disorder (IGD). This study seeks to fill that gap by adopting a within-subject design to investigate the cognitive (craving regulation capacity) and neural (structural changes, resting-state and task-related brain activity, and functional connectivity between the dorsolateral prefrontal cortex [DLPFC] and reward-related brain regions) effects of personalized and precisely navigated rTMS treatment in individuals with IGD.
Participants will receive both real intermittent theta-burst stimulation (iTBS) and sham stimulation targeting the left DLPFC. The study aims to assess how these interventions influence clinical and neural outcomes. Specifically, the experiment will measure changes in craving regulation capacity, and neural markers including resting-state functional connectivity and task-evoked activation patterns in key brain regions associated with addiction, such as the DLPFC and reward system.
The entire experimental protocol spans three weeks and follows a randomized crossover design. Participants will be randomly assigned to one of two intervention sequences: real iTBS followed by sham stimulation, or sham stimulation followed by real iTBS. Each rTMS session will utilize iTBS parameters, lasting approximately 10 minutes, with a minimum of one week between the two sessions to avoid potential carryover effects.
To evaluate the effects of the interventions, clinical assessments (Craving scores), cognitive measures (craving regulation ability), and neuroimaging data (fMRI at rest and during task performance) will be collected after each intervention session. This approach allows for a comprehensive assessment of both the short-term and potential cumulative effects of rTMS on cognitive and neural correlates of IGD, contributing valuable insights into the mechanisms by which rTMS may modulate addictive behaviors and associated neural circuits.
- Conditions
- Internet Gaming Disorder
- Being tested
- real rTMS on the dlPFC, Sham (No Treatment)
- Keywords
- rTMS, Internet gaming disorder, craving, craving regulation
- 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.
real rTMS on the dlPFCOther
During real rTM session, participants will perform the regulation of craving (ROC). In the rest phase, participants need to relax and rest. In the ROC task, participants will regulate craving elicited by gaming pictures using cognitive reappraisal. During the task, reaction times (RTs) and craving scores wil be recorded.
Sham (No Treatment)Other
During the sham rTMS session, participants will perform the regulation of craving (ROC). In the ROC task, participants will regulate craving elicited by gaming pictures using cognitive reappraisal. During the task, reaction times (RTs) and craving scores wil be recorded.
| Study group | Role | What they receive |
|---|---|---|
| real rTMS on the dlPFC | Experimental | rTMS 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 iTBS mode intervention on this DLPFC region. Receives: Other: real rTMS on the dlPFC |
| sham rTMS on the dlPFC | Sham comparator | Each participant will also receive a sham rTMS intervention as a controlled condition. Receives: Other: Sham (No Treatment) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in craving scores in the Cue-Reactivity(CR) task
Comparing the participants who reported craving scores for the game stimuli in the unregulated condition and in the regulated condition in the CR task conducted separately during real rTMS and sham rTMS. Higher scores mean higher craving.
Measured: Approximately 10 minutes during real rTMS condition and sham rTMS
Changes in the DLPFC and craving-related brains (striatum, amygdala) activities in the ROC task following rTMS and sham rTMS
This study will compare the changes in DLPFC activity during the ROC task after real rTMS and sham rTMS. In addition, craving-related brain regions (striatum and amygdala) are also concerned.
Measured: Approximately 14 minutes - 29 minutes after real rTMS and sham rTMS
Alterations in the functional connectivity between the DLPFC and other brain regions in the ROC task following rTMS and sham rTMS
The present study compares the alterations in functional connectivity between the DLPFC and other brain regions (especially those related to reward) after real TMS and sham TMS.
Measured: Approximately 14 minutes - 29 minutes after real rTMS and sham rTMS
Secondary outcomes (3)
Changes in ReHo and fALFF/ALFF in resting-state following rTMS and sham rTMS
This study will compare changes in brain regional homogeneity (ReHo) and the fractional amplitude of low-frequency fluctuations (fALFF/ALFF) during the resting state following real rTMS and sham rTMS, particularly in the DLPFC and reward-related brain regions. These measures reflect the effects of rTMS on participants.
Measured: 5 minutes-13 minutes after real rTMS and sham rTMS
The DLPFC-based functional connectivity alterations during resting-state fMRI
Use seed -based functional connectivity method to explore the alterations in the functional connectivity between the DLPFC and other brain regions, particularly reward-related areas, will be examined.
Measured: 5 minutes-13 minutes after real rTMS and sham rTMS
The intra- and inter-connectivity within brain networks during resting-state fMRI
Graph-theoretic analysis will be used to depict alterations in brain networks following real rTMS and sham rTMS. The present study also concern the changes in intra- and inter-connectivity within brain networks (including executive control systems, reward systems, and default networks) after real rTMS and sham rTMS.
Measured: 5 minutes-13 minutes after real rTMS and sham rTMS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2024
- Study start10 Oct 2024 (estimated)
- Primary completion30 Dec 2024 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 rTMS in a randomized order
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jin-tao Zhang
- Sponsor type
- University, hospital or other
- Collaborators
- Zi-Liang Wang, Medical Ethics Committee of Zhenjiang Mental Health Center
- Responsible party
- Sponsor-investigator, Jin-tao Zhang, Beijing Normal University
- Investigators
- Jin-Tao Zhang, Phd, Principal investigator, Beijing Normal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06634498
- Sponsor's protocol ID
- The effect of rTMS in IGD
- Status last verified
- Oct 2024
- First submitted
- 5 Oct 2024
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Repetitive Transcranial Magnetic Stimulation of the Left Dorsolateral Prefrontal Cortex in Internet Gaming Disorder
- ClinicalTrials.gov ID
- NCT06634498
- Acronym / sponsor ID
- The effect of rTMS in IGD
- Conditions
- Internet Gaming Disorder
- Keywords
- rTMS, Internet gaming disorder, craving, craving regulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Jin-tao ZhangUniversity, hospital or other
- Collaborators
- Zi-Liang Wang, Medical Ethics Committee of Zhenjiang Mental Health Center
- Study start
- 10 Oct 2024 (estimated)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 10 Oct 2024 (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 study aims to investigate the intervention effects of navigated repetitive transcranial magnetic stimulation (rTMS) on craving regulation in individuals with internet gaming disorder (IGD). The primary objectives include: (1) examining the impact of navigated rTMS over the dorsolateral prefrontal cortex (DLPFC) on the gaming cravings, and craving regulation capacity; and (2) exploring the potential neural mechanisms by which rTMS over the DLPFC improves craving intensity, and craving regulation ability.
Detailed description
Repetitive transcranial magnetic stimulation (rTMS) has been shown to reduce cravings in individuals with substance addiction. However, to date, no studies have systematically examined the short-term and long-term clinical and cognitive effects of sustained rTMS treatment on internet gaming disorder (IGD). This study seeks to fill that gap by adopting a within-subject design to investigate the cognitive (craving regulation capacity) and neural (structural changes, resting-state and task-related brain activity, and functional connectivity between the dorsolateral prefrontal cortex [DLPFC] and reward-related brain regions) effects of personalized and precisely navigated rTMS treatment in individuals with IGD.
Participants will receive both real intermittent theta-burst stimulation (iTBS) and sham stimulation targeting the left DLPFC. The study aims to assess how these interventions influence clinical and neural outcomes. Specifically, the experiment will measure changes in craving regulation capacity, and neural markers including resting-state functional connectivity and task-evoked activation patterns in key brain regions associated with addiction, such as the DLPFC and reward system.
The entire experimental protocol spans three weeks and follows a randomized crossover design. Participants will be randomly assigned to one of two intervention sequences: real iTBS followed by sham stimulation, or sham stimulation followed by real iTBS. Each rTMS session will utilize iTBS parameters, lasting approximately 10 minutes, with a minimum of one week between the two sessions to avoid potential carryover effects.
To evaluate the effects of the interventions, clinical assessments (Craving scores), cognitive measures (craving regulation ability), and neuroimaging data (fMRI at rest and during task performance) will be collected after each intervention session. This approach allows for a comprehensive assessment of both the short-term and potential cumulative effects of rTMS on cognitive and neural correlates of IGD, contributing valuable insights into the mechanisms by which rTMS may modulate addictive behaviors and associated neural circuits.
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 rTMS in a randomized order
| Arm | Type | Receives |
|---|---|---|
| real rTMS on the dlPFC | Experimental | Other: real rTMS on the dlPFCrTMS 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 iTBS mode intervention on this DLPFC region. |
| sham rTMS on the dlPFC | Sham comparator | Other: Sham (No Treatment)Each participant will also receive a sham rTMS intervention as a controlled condition. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- DSM-V gaming disorder >5 and scored ≥ 50 on a revised version of Young's online Internet addiction test；
- spent more than 50% of their online time gaming；
- engagement in one of four popular Internet game (Arena of Valor,Genshine, LOL, FPS) for over 20 hours per week for at least 1 year.
Key exclusion criteria (8 listed)
- current or history of use of illegal substances and gambling;
- current or history of psychiatric or neurological illness;
- current use of psychotropic medications;
- cognitive impairment as assessed by the Mini-International Neuropsychiatric Interview；
- surgery, head trauma or heart related diseases in the past year；
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 |
|---|---|---|
| real rTMS on the dlPFCDuring real rTM session, participants will perform the regulation of craving (ROC). In the rest phase, participants need to relax and rest. In the ROC task, participants will regulate craving elicited by gaming pictures using cognitive reappraisal. During the task, reaction times (RTs) and craving scores wil be recorded. | Other | real rTMS on the dlPFC |
| Sham (No Treatment)During the sham rTMS session, participants will perform the regulation of craving (ROC). In the ROC task, participants will regulate craving elicited by gaming pictures using cognitive reappraisal. During the task, reaction times (RTs) and craving scores wil be recorded. | Other | sham rTMS on the dlPFC |
Primary outcome
Change in craving scores in the Cue-Reactivity(CR) task
Time frame: Approximately 10 minutes during real rTMS condition and sham rTMS
Comparing the participants who reported craving scores for the game stimuli in the unregulated condition and in the regulated condition in the CR task conducted separately during real rTMS and sham rTMS. Higher scores mean higher craving.
Changes in the DLPFC and craving-related brains (striatum, amygdala) activities in the ROC task following rTMS and sham rTMS
Time frame: Approximately 14 minutes - 29 minutes after real rTMS and sham rTMS
This study will compare the changes in DLPFC activity during the ROC task after real rTMS and sham rTMS. In addition, craving-related brain regions (striatum and amygdala) are also concerned.
Alterations in the functional connectivity between the DLPFC and other brain regions in the ROC task following rTMS and sham rTMS
Time frame: Approximately 14 minutes - 29 minutes after real rTMS and sham rTMS
The present study compares the alterations in functional connectivity between the DLPFC and other brain regions (especially those related to reward) after real TMS and sham TMS.
3 secondary outcomes
Changes in ReHo and fALFF/ALFF in resting-state following rTMS and sham rTMS
Time frame: 5 minutes-13 minutes after real rTMS and sham rTMS
The DLPFC-based functional connectivity alterations during resting-state fMRI
Time frame: 5 minutes-13 minutes after real rTMS and sham rTMS
The intra- and inter-connectivity within brain networks during resting-state fMRI
Time frame: 5 minutes-13 minutes after real rTMS and sham rTMS
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- 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
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing real rTMS on the dlPFC in people with Internet Gaming Disorder, run by Jin-tao Zhang at 2 sites 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 3 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jin-Tao Zhang, Phd (15010233046, zhangjintao@bnu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in craving scores in the Cue-Reactivity(CR) task (time frame: Approximately 10 minutes during real rTMS condition and sham rTMS). 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?
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 15 Oct 2024.