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| Name | Class |
|---|---|
| Zi-Liang Wang, Medical Ethics Committee of Zhenjiang Mental Health Center | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| sham rTMS on the dlPFC | Sham Comparator | Each participant will also receive a sham rTMS intervention as a controlled condition. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| real rTMS on the dlPFC | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | Approximately 14 minutes - 29 minutes after real rTMS and sham rTMS |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 5 minutes-13 minutes after real rTMS and sham rTMS |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jin-Tao Zhang, Phd | Contact | 15010233046 | zhangjintao@bnu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Jin-Tao Zhang, Phd | Beijing Normal University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical Ethics Committee of Zhenjiang Mental Health Center | Recruiting | Zhenjiang | Jiangsu | China |
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| ID | Term |
|---|---|
| D000082424 | Internet Addiction Disorder |
| ID | Term |
|---|---|
| D000088942 | Technology Addiction |
| D016739 | Behavior, Addictive |
| D003192 | Compulsive Behavior |
| D007175 | Impulsive Behavior |
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| ID | Term |
|---|---|
| C005703 | salicylhydroxamic acid |
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within-subject, sham-controlled design: all subjects will receive active and sham rTMS in a randomized order
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single blind: both participants and experiment won't know the stimulation condition
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| 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. |
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| 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. | 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. | 5 minutes-13 minutes after real rTMS and sham rTMS |
| State Key Laboratory of Cognitive Neuroscience and Learning | Recruiting | Beijing | China |
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| D001519 |
| Behavior |