- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06634498
The Effect of Repetitive Transcranial Magnetic Stimulation for Internet Gaming Disorder
The Effect of Repetitive Transcranial Magnetic Stimulation of the Left Dorsolateral Prefrontal Cortex in Internet Gaming Disorder
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jin-Tao Zhang, Phd
- Phone Number: 15010233046
- Email: zhangjintao@bnu.edu.cn
Study Locations
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Beijing, China
- Recruiting
- State Key Laboratory of Cognitive Neuroscience and Learning
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Contact:
- Jin-Tao Zhang, Phd
- Email: zhangjintao@bnu.edu.cn
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Jiangsu
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Zhenjiang, Jiangsu, China
- Recruiting
- Medical Ethics Committee of Zhenjiang Mental Health Center
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Contact:
- Zi-Liang Wang, Phd
- Phone Number: 18395949625
- Email: wangziliang201@163.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
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;
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: real rTMS on the dlPFC
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.
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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.
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Sham Comparator: sham rTMS on the dlPFC
Each participant will also receive a sham rTMS intervention as a controlled condition.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in craving scores in the Cue-Reactivity(CR) task
Time Frame: Approximately 10 minutes during real rTMS condition and sham rTMS
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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.
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Approximately 10 minutes during real rTMS condition and sham rTMS
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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
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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.
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Approximately 14 minutes - 29 minutes after real rTMS and sham rTMS
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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
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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.
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Approximately 14 minutes - 29 minutes after real rTMS and sham rTMS
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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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
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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.
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5 minutes-13 minutes after real rTMS and sham rTMS
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The DLPFC-based functional connectivity alterations during resting-state fMRI
Time Frame: 5 minutes-13 minutes after real rTMS and sham rTMS
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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.
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5 minutes-13 minutes after real rTMS and sham rTMS
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The intra- and inter-connectivity within brain networks during resting-state fMRI
Time Frame: 5 minutes-13 minutes after real rTMS and sham rTMS
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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.
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5 minutes-13 minutes after real rTMS and sham rTMS
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jin-Tao Zhang, Phd, Beijing Normal University
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- The effect of rTMS in IGD
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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