NCT06634498

Brief Summary

This study aims to investigate the intervention effects of navigated repetitive transcranial magnetic stimulation (rTMS) on craving regulation in individuals with internet gaming disorder (IGD). The primary objectives include: (1) examining the impact of navigated rTMS over the dorsolateral prefrontal cortex (DLPFC) on the gaming cravings, and craving regulation capacity; and (2) exploring the potential neural mechanisms by which rTMS over the DLPFC improves craving intensity, and craving regulation ability.

Trial Health

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Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

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

October 5, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 10, 2024

Completed
Same day until next milestone

Study Start

First participant enrolled

October 10, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2025

Completed
Last Updated

October 15, 2024

Status Verified

October 1, 2024

Enrollment Period

3 months

First QC Date

October 5, 2024

Last Update Submit

October 9, 2024

Conditions

Keywords

rTMSInternet gaming disordercravingcraving regulation

Outcome Measures

Primary Outcomes (3)

  • Change in craving scores in the Cue-Reactivity(CR) task

    Comparing the participants who reported craving scores for the game stimuli in the unregulated condition and in the regulated condition in the CR task conducted separately during real rTMS and sham rTMS. Higher scores mean higher craving.

    Approximately 10 minutes during real rTMS condition and sham rTMS

  • Changes in the DLPFC and craving-related brains (striatum, amygdala) activities in the ROC task following rTMS and sham rTMS

    This study will compare the changes in DLPFC activity during the ROC task after real rTMS and sham rTMS. In addition, craving-related brain regions (striatum and amygdala) are also concerned.

    Approximately 14 minutes - 29 minutes after real rTMS and sham rTMS

  • Alterations in the functional connectivity between the DLPFC and other brain regions in the ROC task following rTMS and sham rTMS

    The present study compares the alterations in functional connectivity between the DLPFC and other brain regions (especially those related to reward) after real TMS and sham TMS.

    Approximately 14 minutes - 29 minutes after real rTMS and sham rTMS

Secondary Outcomes (3)

  • Changes in ReHo and fALFF/ALFF in resting-state following rTMS and sham rTMS

    5 minutes-13 minutes after real rTMS and sham rTMS

  • The DLPFC-based functional connectivity alterations during resting-state fMRI

    5 minutes-13 minutes after real rTMS and sham rTMS

  • The intra- and inter-connectivity within brain networks during resting-state fMRI

    5 minutes-13 minutes after real rTMS and sham rTMS

Study Arms (2)

real rTMS on the dlPFC

EXPERIMENTAL

rTMS on the DLPFC Dorsolateral prefrontal cortex (DLPFC) target will be identified by the baseline functional magnetic resonance imaging (fMRI) study for regulation of craving using a separate sample. During the intervention, each participant will receive an iTBS mode intervention on this DLPFC region.

Other: real rTMS on the dlPFC

sham rTMS on the dlPFC

SHAM COMPARATOR

Each participant will also receive a sham rTMS intervention as a controlled condition.

Other: Sham (No Treatment)

Interventions

During real rTM session, participants will perform the regulation of craving (ROC). In the rest phase, participants need to relax and rest. In the ROC task, participants will regulate craving elicited by gaming pictures using cognitive reappraisal. During the task, reaction times (RTs) and craving scores wil be recorded.

real rTMS on the dlPFC

During the sham rTMS session, participants will perform the regulation of craving (ROC). In the ROC task, participants will regulate craving elicited by gaming pictures using cognitive reappraisal. During the task, reaction times (RTs) and craving scores wil be recorded.

sham rTMS on the dlPFC

Eligibility Criteria

Age18 Years - 30 Years
Sexall(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • DSM-V gaming disorder \>5 and scored ≥ 50 on a revised version of Young's online Internet addiction test;
  • spent more than 50% of their online time gaming;
  • engagement in one of four popular Internet game (Arena of Valor,Genshine, LOL, FPS) for over 20 hours per week for at least 1 year.

You may not qualify if:

  • current or history of use of illegal substances and gambling;
  • current or history of psychiatric or neurological illness;
  • current use of psychotropic medications;
  • cognitive impairment as assessed by the Mini-International Neuropsychiatric Interview;
  • surgery, head trauma or heart related diseases in the past year;
  • a history of epilepsy or seizures or increased risk of seizures for any reason;
  • metal implants or tattoos of the neck or head;
  • claustrophobia.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Medical Ethics Committee of Zhenjiang Mental Health Center

Zhenjiang, Jiangsu, China

RECRUITING

State Key Laboratory of Cognitive Neuroscience and Learning

Beijing, China

RECRUITING

MeSH Terms

Conditions

Internet Addiction Disorder

Interventions

salicylhydroxamic acid

Condition Hierarchy (Ancestors)

Technology AddictionBehavior, AddictiveCompulsive BehaviorImpulsive BehaviorBehavior

Study Officials

  • Jin-Tao Zhang, Phd

    Beijing Normal University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jin-Tao Zhang, Phd

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
single blind: both participants and experiment won't know the stimulation condition
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: within-subject, sham-controlled design: all subjects will receive active and sham rTMS in a randomized order
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 5, 2024

First Posted

October 10, 2024

Study Start

October 10, 2024

Primary Completion

December 30, 2024

Study Completion

June 30, 2025

Last Updated

October 15, 2024

Record last verified: 2024-10

Locations