The Effect of Repetitive Transcranial Magnetic Stimulation for Internet Gaming Disorder

Official title

The Effect of Repetitive Transcranial Magnetic Stimulation of the Left Dorsolateral Prefrontal Cortex in Internet Gaming Disorder

Overview

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.

Interventions

• Other real rTMS on the dlPFC
  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.
• Other 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.

Primary outcome measures

• Change in craving scores in the Cue-Reactivity(CR) task [Time frame: 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 [Time frame: 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 [Time frame: Approximately 14 minutes - 29 minutes after real rTMS and sham rTMS]

Secondary outcome measures (3)

• 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]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Crossover

Masking

Double blind

Primary purpose

Basic science

Study locations

China · 2 centers

• Medical Ethics Committee of Zhenjiang Mental Health Center — Zhenjiang
• State Key Laboratory of Cognitive Neuroscience and Learning — Beijing

Identifiers

NCT: NCT06634498 · The effect of rTMS in IGD

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗