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NCT Number: NCT06759051

Targeted TDCS Intervention for Internet Gaming Disorder

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's central parietal cortex; and the third and fourth groups had the anode at the subject'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.

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Key information

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Institute on Drug Dependence, Peking University

Beijing, Beijing Municipality, 100191, China

Location contact

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

tDCS

Device

The stimulation pattern for the true intervention was that the current level ramped up from 0 to 2 mA for the first 10 seconds of stimulation, then maintained at 2 mA for 19 minutes and 40 seconds, and then ramped down from 2 mA to 0 mA for the last 10 seconds, all over a 20-minute period.

Sham (No Treatment)

Device

In contrast to the active intervention, the sham intervention consisted of a current ramp from 0mA to 2mA for the first 20 seconds of stimulus onset, followed by a ramp down to 0mA. the current was maintained at 0mA for 19 minutes and 20 seconds, and then the current was ramped from 0mA to 2mA for the last 20 seconds, followed by a ramp down to 0mA. The entire procedure lasted the same as the active intervention, which lasted for 20 minutes.

Primary outcomes

  1. Craving Of Game (VAS)

    Time frame: "From enrollment to the end of treatment at 1 month"

    Subjects' thirst was indicated by scores on a questionnaire (VAS),The range is 0-9, with 0 meaning that you don't want to play the game very much after looking at the picture, and 9 meaning that you want to play the game very much after looking at the picture.

Secondary outcomes

  1. Craving Of Game (Questionnaire on Gaming Urge, Brief Version(QGU-B))

    Time frame: "From enrollment to the end of treatment at 1 month"

    Subjects' thirst was indicated by scores on a questionnaire (QGU-B),The QGU-B scale consists of 10 items, and the intensity of each item is indicated by a score from 1 to 7, with higher scores indicating a stronger urge to play.

  2. Severity of game addiction (DSM-5)

    Time frame: "From enrollment to the end of treatment at 1 month"

    The severity of the subject's gaming addiction is indicated by the score on the questionnaire (DSM-5),The DSM-5 scale consists of nine items, each of which has a "yes" or "no" choice, with a "yes" choice counting as one point and a "no" choice being indicated by a score from 1 to 7. "The higher the score, the more severe the online game use disorder.

  3. Severity of game addiction (Internet Gaming Disorder Scale-Short-Form(IGD-S9))

    Time frame: "From enrollment to the end of treatment at 1 month"

    The severity of the subject's gaming addiction is indicated by the score on the questionnaire (IGD-S9),The IGD-S9 scale consists of nine items with scores ranging from 9 to 45, with higher scores indicating higher levels of addiction.

  4. Electroencephalographic (EEG) index

    Time frame: "From enrollment to the end of treatment at 1 month"

    Brain waves of subjects in resting or task states, include P300 at Pz electrode, point;time frequency of P300 (alpha, theta, beta, delta).

  5. Behavioural indicators under EEG tasks

    Time frame: "From enrollment to the end of treatment at 1 month"

    Under the Iowa Gambling task (IGT), participants were analyzed for the percentage of participants choosing each type of card (high-risk but high-reward, low-risk but low-reward), thus comparing their risky decision-making abilities; under the Signal Stopping task (SST), participants were analyzed for their stop-signal reaction time (SSRT), which is the amount of time it takes an individual to successfully inhibit a response that has been initiated, thus assessing response inhibition; and under the Monetary Incentive Delay task (MID), subjects were analyzed for five conditions (large win, large loss, small win, small loss, neutral ) reaction times and accuracy, assessing participants' expectations of rewards and punishments and outcome feedback.

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

Peking University

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 6, 2025
Registry last updated
Jan 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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