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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06063642
Other study ID # BSERE23-APP004-ICI
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 15, 2023
Est. completion date June 1, 2024

Study information

Verified date September 2023
Source University of Macau
Contact Zhiying Zhao, Ph.D
Phone (853) 8822 9182
Email zhiyingzhao@um.edu.mo
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 regions.


Recruitment information / eligibility

Status Recruiting
Enrollment 20
Est. completion date June 1, 2024
Est. primary completion date April 20, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 28 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Device:
Neurofeedback training
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 training
A controlled form of neurofeedback training that provides feedback irrelevant to the targeted mental process.

Locations

Country Name City State
Macau Centre for Cognitive and Brain Sciences, University of Macau Taipa

Sponsors (1)

Lead Sponsor Collaborator
University of Macau

Country where clinical trial is conducted

Macau, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change from Baseline in self-reported urge for internet gaming as assessed by Visual Analog Scales (1 to 100) Up to 30 days after the intervention session
Secondary 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. Up to 3 days
Secondary 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. Up to 3 days
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