NCT06063642

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 31, 2023

Completed
4 months until next milestone

First Posted

Study publicly available on registry

October 2, 2023

Completed
13 days until next milestone

Study Start

First participant enrolled

October 15, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 20, 2024

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2024

Completed
Last Updated

July 30, 2024

Status Verified

September 1, 2023

Enrollment Period

4 months

First QC Date

May 31, 2023

Last Update Submit

July 28, 2024

Conditions

Keywords

neurofeedbackbehavior addiction

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Change in reward-related activity during exposure to internet gaming videos

    Up to 3 days

  • Change in inhibitory response in the affective Go/Nogo task

    Up to 3 days

Study Arms (2)

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.

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.

Device: Sham feedback training

Interventions

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.

Experimental neurofeedback intervention

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

Sham feedback intervention

Eligibility Criteria

Age18 Years - 28 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre for Cognitive and Brain Sciences, University of Macau

Taipa, 99078, Macau

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Internet Addiction Disorder

Condition Hierarchy (Ancestors)

Technology AddictionBehavior, AddictiveCompulsive BehaviorImpulsive BehaviorBehavior

Study Officials

  • Zhen Yuan, Ph.D

    University of Macau

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
All participants will be blind to the intervention group assignment until they complete the entire study procedure. An outcome assessor who is blind to this assignment will collect the primary outcome measurement data.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Eligible candidates will be randomly assigned to either receive the experimental feedback intervention or sham feedback intervention.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 31, 2023

First Posted

October 2, 2023

Study Start

October 15, 2023

Primary Completion

February 20, 2024

Study Completion

March 1, 2024

Last Updated

July 30, 2024

Record last verified: 2023-09

Locations