- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06063642
Neurofeedback for Internet Gaming Addiction
July 28, 2024 updated by: University of Macau
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Taipa, Macau, 99078
- Centre for Cognitive and Brain Sciences, University of Macau
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental neurofeedback intervention
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.
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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.
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Sham Comparator: Sham feedback intervention
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.
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A controlled form of neurofeedback training that provides feedback irrelevant to the targeted mental process.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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
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Up to 30 days after the intervention session
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in reward-related activity during exposure to internet gaming videos
Time Frame: Up to 3 days
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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.
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Up to 3 days
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Change in inhibitory response in the affective Go/Nogo task
Time Frame: Up to 3 days
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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.
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Up to 3 days
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Zhen Yuan, Ph.D, University of Macau
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 15, 2023
Primary Completion (Actual)
February 20, 2024
Study Completion (Actual)
March 1, 2024
Study Registration Dates
First Submitted
May 31, 2023
First Submitted That Met QC Criteria
September 29, 2023
First Posted (Actual)
October 2, 2023
Study Record Updates
Last Update Posted (Actual)
July 30, 2024
Last Update Submitted That Met QC Criteria
July 28, 2024
Last Verified
September 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- BSERE23-APP004-ICI
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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