Clinical trial NCT06759051: Targeted TDCS Intervention for Internet Gaming Disorder
Official title: Targeted TDCS Intervention for Internet Gaming Disorder
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Internet Gaming Disorder
Keywords: Internet gaming disorder
tDCS
IGD
Lead sponsor: Peking University
Sponsor class: OTHER
First posted: 2025-01-06
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this project is to compare the effects of the newly discovered parietal cortex (Pz electrode point) with the dorsolateral prefrontal cortex (F3 electrode point), which has been commonly used in previous studies, and to further develop a closed-loop intervention method of real-time tDCS under on-line electroencephalography (EEG-tDCS), so as to realise an individualised diagnosis and treatment for online game addicts.

This study is divided into two parts, the first part to explore the effectiveness of the new target, using a randomised group design, using tDCS intervention, the subject population is online game addicts, the sample size is about 120. Participants underwent baseline information collection on the first day of the experiment including: basic demographic information, assessment of internet addiction severity and craving; EEG collection in resting state as well as task state (Game Cue Response Task, Signal Stop Task, Iowa Gambling Task). The tDCS intervention under the game cue response task was conducted on the second and third days of the experiment, divided into four groups (the first and second groups were the true-false stimulation groups with the anode at the trapezius muscle at the base of the right neck and the cathode at the subject\&#39;s central parietal cortex; and the third and fourth groups had the anode at the subject\&#39;s left dorsolateral prefrontal cortex, and the cathode at the trapezius muscle at the base of the right neck), with 20 min of intervention each time and the Game craving level was assessed before and after the intervention. Resting-state and task-state (Game Cue Response Task, Signal Stop Task, Iowa Gambling Task) EEG acquisitions were performed at the end of the intervention.The second part of the EEG-tDCS closed-loop intervention was conducted, using a randomised group design with a sample size of about 60 subjects who are addicted to online games. On the first day of the experiment, baseline information was collected, and a personalised EEG classifier model was built for each subject based on the EEG signals of the game cue response task; on the second and third days of the experiment, EEG-tDCS closed-loop intervention was conducted, divided into true intervention and sham intervention groups, with the true intervention group identifying whether subjects were in an addictive state in real time under the game cue response task, and addictive states were identified by giving real-time short-time short-time short-time short-time short-time short-time short-time intervention at target locations. The real-time short-term tDCS intervention was given at the target location for a total duration of 20 minutes, and the level of game craving was assessed after the intervention; at the end of the intervention, the EEG was collected in the resting state and the task state (game cue response task, signal stopping task, and Iowa gambling task). The two-part experiment followed up subjects with weekly post-intervention versus one-month post-intervention gaming severity assessments, with resting-state and task-state (gaming cue-response task, signal-stopping task, Iowa gambling task) electroencephalogram acquisitions.


Eligibility criteria: Inclusion Criteria:

1. Age range of 18-30 years old; and
2. Familiar with and mainly play King\&#39;s Honour;
3. IGDS9-SF score ≥ 32 points
4. Meets DSM-5 diagnostic criteria for online game addiction;
5. Played online games for at least 14 hours per week in the past 1 year;
6. signed an informed consent form to voluntarily participate in this trial.

Exclusion Criteria:

1. severe mental illness, neurological disorder or physical illness; and
2. History of substance abuse/dependence (including alcohol);
3. Contraindications to EEG acquisition;
4. Colour blindness, colour deficiency or other vision-related eye diseases affecting vision;
5. Pregnant and breastfeeding women, or women who are menstruating; and
6. Poor compliance: subjects who, in the opinion of the investigator, are unable to co-operate with the trial.

Primary outcomes:
measure: Craving Of Game (VAS)
timeFrame: &#34;From enrollment to the end of treatment at 1 month&#34;
Secondary outcomes:
measure: Craving Of Game (Questionnaire on Gaming Urge, Brief Version(QGU-B))
timeFrame: &#34;From enrollment to the end of treatment at 1 month&#34;
measure: Severity of game addiction (DSM-5)
timeFrame: &#34;From enrollment to the end of treatment at 1 month&#34;
measure: Severity of game addiction (Internet Gaming Disorder Scale-Short-Form(IGD-S9))
timeFrame: &#34;From enrollment to the end of treatment at 1 month&#34;
measure: Electroencephalographic (EEG) index
timeFrame: &#34;From enrollment to the end of treatment at 1 month&#34;
measure: Behavioural indicators under EEG tasks
timeFrame: &#34;From enrollment to the end of treatment at 1 month&#34;
Other outcomes:
Locations:
city: Beijing
country: China
facility: National Institute on Drug Dependence, Peking University
state: Beijing
Study officials:
References: