The Effect of Repetitive Transcranial Magnetic Stimulation of the Left Dorsolateral Prefrontal Cortex in Internet Gaming Disorder
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Change in craving scores in the Cue-Reactivity(CR) task
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
盲法说明
single blind: both participants and experiment won't know the stimulation condition
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Change in craving scores in the Cue-Reactivity(CR) task
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- Changes in ReHo and fALFF/ALFF in resting-state following rTMS and sham rTMS(5 minutes-13 minutes after real rTMS and sham rTMS)
- The DLPFC-based functional connectivity alterations during resting-state fMRI(5 minutes-13 minutes after real rTMS and sham rTMS)
- The intra- and inter-connectivity within brain networks during resting-state fMRI(5 minutes-13 minutes after real rTMS and sham rTMS)
研究者
Jin-tao Zhang
Professor
Beijing Normal University