Internet Gaming DisorderNCT06063642
Neurofeedback for Internet Gaming Addiction
A study testing Neurofeedback training in people with Internet Gaming Disorder, run by University of Macau at 1 site in Macau.
Trial summary
The primary aim of this study is to evaluate the therapeutic potential of real-time functional magnetic resonance imaging (MRI) neurofeedback in alleviating internet gaming disorder (IGD) symptoms by training individuals with such symptoms to down-regulate the activity in their reward-processing-related midbrain… Read more about this study
- Who is it for?
- Ages 18 to 28 yearsHealthy volunteers can take part
- Conditions the study is for
- Internet Gaming Disorder
- What is being tested?
- Neurofeedback training
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteMacau
- Study dates
- 15 Oct 2023to 1 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 28 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Meet at least five of the Diagnostic and Statistical Manual of Mental Disorders fifth edition (DSM-5) criteria for IGD and score 38 or above on the Internet Addiction Test (IAT)
- First language is Chinese (Mandarin)
- Right-handed
- Have played the mobile game "King of Glory" for more than 3 years
- Ability to give informed consent
- Normal or corrected-to-normal vision
Who cannot join
- Any primary diagnosis of a current psychological or neurological disorder
- Any history of psychological or neurological disorder
- Any MRI contraindication
- Currently on a psychotropic medication
- Any history of substance dependence
- Any history of brain injury or surgery
Trial locations and contacts
1 site in 1 country.
Macau1 site
Centre for Cognitive and Brain Sciences, University of Macau
Taipa, 99078
About this study
Official title: Real-time Functional Magnetic Resonance Imaging Neurofeedback Treatment for Young Adults With Internet Gaming Addiction
The primary aim of this study is to evaluate the therapeutic potential of real-time functional magnetic resonance imaging (MRI) neurofeedback in alleviating internet gaming disorder (IGD) symptoms by training individuals with such symptoms to down-regulate the activity in their reward-processing-related midbrain regions.
- Conditions
- Internet Gaming Disorder
- Being tested
- Neurofeedback training, Sham feedback training
- Keywords
- neurofeedback, behavior addiction
- Medical subject headings
- Internet Addiction Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neurofeedback trainingDevice
Neurofeedback training is a type of non-invasive brain modulation technique that enables individuals to self-regulate brain activity patterns by providing them feedback on specific activity measures. Effective self-regulation is often linked to changes in cognition, behavior, and clinical symptoms.
Sham feedback trainingDevice
A controlled form of neurofeedback training that provides feedback irrelevant to the targeted mental process.
| Study group | Role | What they receive |
|---|---|---|
| Experimental neurofeedback intervention | Experimental | In an approximately 30-minute training session, participants receive activity feedback from a midbrain region involved in reward processing and gaming addiction. Feedback will be presented in the form of a thermometer/bar in the middle of the screen and updated every two seconds. They will be trained to down-regulate the activity in this region with the help of this feedback using cognitive strategies. This down-regulation training is believed to be beneficial to addictive behaviors by the investigators. Receives: Device: Neurofeedback training |
| Sham feedback intervention | Sham comparator | In an approximately 30-minute training session, participants receive activity feedback from a brain region irrelevant to reward processing or gaming addictive behavior. The feedback presentation form and task instructions will be the same as for the experimental group. Based on the functional role of the feedback region, the investigators do not believe this feedback training will change the addictive behaviors of the participants who receive this intervention. Receives: Device: Sham feedback training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in self-reported urge for internet gaming as assessed by Visual Analog Scales (1 to 100)
Measured: Up to 30 days after the intervention session
Secondary outcomes (2)
Change in reward-related activity during exposure to internet gaming videos
Participants will complete cue-reactivity tasks in which they are exposed to video clips captured from the dependent mobile game before and after the intervention. Functional MRI data will be collected to measure their pre- to post-intervention changes in the brain reward processing pathways.
Measured: Up to 3 days
Change in inhibitory response in the affective Go/Nogo task
This task that uses affective Chinese characters as stimuli will be used to examine changes in inhibitory control performance as well as changes in brain activity associated with this cognitive process pre- to post-intervention.
Measured: Up to 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2023
- Study start15 Oct 2023
- Primary completion20 Feb 2024
- Study completion1 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Internet Gaming DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Eligible candidates will be randomly assigned to either receive the experimental feedback intervention or sham feedback intervention.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Macau
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zhen Yuan, Ph.D, Study director, University of Macau
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06063642
- Sponsor's protocol ID
- BSERE23-APP004-ICI
- Status last verified
- Sep 2023
- First submitted
- 31 May 2023
- Last updated
- 30 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gu A, Chan CL, Xu X, Dexter JP, Becker B, Zhao Z. Real-Time fMRI Neurofeedback Modulation of Dopaminergic Midbrain Activity in Young Adults With Elevated Internet Gaming Disorder Risk: Randomized Controlled Trial. J Med Internet Res. 2025 Jan 29;27:e64687. doi: 10.2196/64687.
PubMed 39879613
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-time Functional Magnetic Resonance Imaging Neurofeedback Treatment for Young Adults With Internet Gaming Addiction
- ClinicalTrials.gov ID
- NCT06063642
- Acronym / sponsor ID
- BSERE23-APP004-ICI
- Conditions
- Internet Gaming Disorder
- Keywords
- neurofeedback, behavior addiction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of MacauUniversity, hospital or other
- Study start
- 15 Oct 2023 (actual)
- Primary completion
- 20 Feb 2024 (actual)
- Study completion
- 1 Mar 2024 (actual)
- First posted
- 2 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary aim of this study is to evaluate the therapeutic potential of real-time functional magnetic resonance imaging (MRI) neurofeedback in alleviating internet gaming disorder (IGD) symptoms by training individuals with such symptoms to down-regulate the activity in their reward-processing-related midbrain regions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Eligible candidates will be randomly assigned to either receive the experimental feedback intervention or sham feedback intervention.
| Arm | Type | Receives |
|---|---|---|
| Experimental neurofeedback intervention | Experimental | Device: Neurofeedback trainingIn an approximately 30-minute training session, participants receive activity feedback from a midbrain region involved in reward processing and gaming addiction. Feedback will be presented in the form of a thermometer/bar in the middle of the screen and updated every two seconds. They will be trained to down-regulate the activity in this region with the help of this feedback using cognitive strategies. This down-regulation training is believed to be beneficial to addictive behaviors by the investigators. |
| Sham feedback intervention | Sham comparator | Device: Sham feedback trainingIn an approximately 30-minute training session, participants receive activity feedback from a brain region irrelevant to reward processing or gaming addictive behavior. The feedback presentation form and task instructions will be the same as for the experimental group. Based on the functional role of the feedback region, the investigators do not believe this feedback training will change the addictive behaviors of the participants who receive this intervention. |
Who may qualify
- Ages
- 18 to 28 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Meet at least five of the Diagnostic and Statistical Manual of Mental Disorders fifth edition (DSM-5) criteria for IGD and score 38 or above on the Internet Addiction Test (IAT)
- First language is Chinese (Mandarin)
- Right-handed
- Have played the mobile game "King of Glory" for more than 3 years
- Ability to give informed consent
Key exclusion criteria (6 listed)
- Any primary diagnosis of a current psychological or neurological disorder
- Any history of psychological or neurological disorder
- Any MRI contraindication
- Currently on a psychotropic medication
- Any history of substance dependence
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neurofeedback trainingNeurofeedback training is a type of non-invasive brain modulation technique that enables individuals to self-regulate brain activity patterns by providing them feedback on specific activity measures. Effective self-regulation is often linked to changes in cognition, behavior, and clinical symptoms. | Device | Experimental neurofeedback intervention |
| Sham feedback trainingA controlled form of neurofeedback training that provides feedback irrelevant to the targeted mental process. | Device | Sham feedback intervention |
Primary outcome
Change from Baseline in self-reported urge for internet gaming as assessed by Visual Analog Scales (1 to 100)
Time frame: Up to 30 days after the intervention session
2 secondary outcomes
Change in reward-related activity during exposure to internet gaming videos
Time frame: Up to 3 days
Change in inhibitory response in the affective Go/Nogo task
Time frame: Up to 3 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2024.
- Derived from this study: PubMed 39879613Gu A, Chan CL, Xu X, Dexter JP, Becker B, Zhao Z. Real-Time fMRI Neurofeedback Modulation of Dopaminergic Midbrain Activity in Young Adults With Elevated Internet Gaming Disorder Risk: Randomized Controlled Trial. J Med Internet Res. 2025 Jan 29;27:e64687. doi: 10.2196/64687.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhen Yuan, Ph.D study director
University of Macau
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neurofeedback training in people with Internet Gaming Disorder, run by University of Macau at 1 site in Macau.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Macau. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in self-reported urge for internet gaming as assessed by Visual Analog Scales (1 to 100) (time frame: Up to 30 days after the intervention session). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06063642, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2024.