Clinical trial NCT06634498: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Internet Gaming Disorder
Keywords: rTMS
Internet gaming disorder
craving
craving regulation
Lead sponsor: Beijing Normal University
Sponsor class: OTHER
Collaborators: name: Zi-Liang Wang, Medical Ethics Committee of Zhenjiang Mental Health Center
First posted: 2024-10-10
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: within-subject, sham-controlled design: all subjects will receive active and sham rTMS in a randomized order
Primary purpose: BASIC_SCIENCE

Brief 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). 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.

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.

Primary outcomes:
measure: Change in craving scores in the Cue-Reactivity(CR) task
timeFrame: Approximately 10 minutes during real rTMS condition and sham rTMS
measure: Changes in the DLPFC and craving-related brains (striatum, amygdala) activities in the ROC task following rTMS and sham rTMS
timeFrame: Approximately 14 minutes - 29 minutes after real rTMS and sham rTMS
measure: Alterations in the functional connectivity between the DLPFC and other brain regions in the ROC task following rTMS and sham rTMS
timeFrame: Approximately 14 minutes - 29 minutes after real rTMS and sham rTMS
Secondary outcomes:
measure: Changes in ReHo and fALFF/ALFF in resting-state following rTMS and sham rTMS
timeFrame: 5 minutes-13 minutes after real rTMS and sham rTMS
measure: The DLPFC-based functional connectivity alterations during resting-state fMRI
timeFrame: 5 minutes-13 minutes after real rTMS and sham rTMS
measure: The intra- and inter-connectivity within brain networks during resting-state fMRI
timeFrame: 5 minutes-13 minutes after real rTMS and sham rTMS
Other outcomes:
Locations:
city: Zhenjiang
country: China
facility: Medical Ethics Committee of Zhenjiang Mental Health Center
state: Jiangsu
city: Beijing
country: China
facility: State Key Laboratory of Cognitive Neuroscience and Learning
Study officials:
affiliation: Beijing Normal University
name: Jin-Tao Zhang, Phd
role: PRINCIPAL_INVESTIGATOR
References: