The Effect of Repetitive Transcranial Magnetic Stimulation for Internet Gaming Disorder

NCT ID: NCT06634498

Last Updated: 2024-10-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-10

Study Completion Date

2025-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Repetitive transcranial magnetic stimulation (rTMS) has been shown to reduce cravings in individuals with substance addiction. However, to date, no studies have systematically examined the short-term and long-term clinical and cognitive effects of sustained rTMS treatment on internet gaming disorder (IGD). This study seeks to fill that gap by adopting a within-subject design to investigate the cognitive (craving regulation capacity) and neural (structural changes, resting-state and task-related brain activity, and functional connectivity between the dorsolateral prefrontal cortex \[DLPFC\] and reward-related brain regions) effects of personalized and precisely navigated rTMS treatment in individuals with IGD.

Participants will receive both real intermittent theta-burst stimulation (iTBS) and sham stimulation targeting the left DLPFC. The study aims to assess how these interventions influence clinical and neural outcomes. Specifically, the experiment will measure changes in craving regulation capacity, and neural markers including resting-state functional connectivity and task-evoked activation patterns in key brain regions associated with addiction, such as the DLPFC and reward system.

The entire experimental protocol spans three weeks and follows a randomized crossover design. Participants will be randomly assigned to one of two intervention sequences: real iTBS followed by sham stimulation, or sham stimulation followed by real iTBS. Each rTMS session will utilize iTBS parameters, lasting approximately 10 minutes, with a minimum of one week between the two sessions to avoid potential carryover effects.

To evaluate the effects of the interventions, clinical assessments (Craving scores), cognitive measures (craving regulation ability), and neuroimaging data (fMRI at rest and during task performance) will be collected after each intervention session. This approach allows for a comprehensive assessment of both the short-term and potential cumulative effects of rTMS on cognitive and neural correlates of IGD, contributing valuable insights into the mechanisms by which rTMS may modulate addictive behaviors and associated neural circuits.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Internet Gaming Disorder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

within-subject, sham-controlled design: all subjects will receive active and sham rTMS in a randomized order
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators
single blind: both participants and experiment won't know the stimulation condition

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

real rTMS on the dlPFC

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.

Group Type EXPERIMENTAL

real rTMS on the dlPFC

Intervention Type OTHER

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.

sham rTMS on the dlPFC

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

Group Type SHAM_COMPARATOR

Sham (No Treatment)

Intervention Type OTHER

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

real rTMS on the dlPFC

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.

Intervention Type OTHER

Sham (No Treatment)

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Zi-Liang Wang, Medical Ethics Committee of Zhenjiang Mental Health Center

UNKNOWN

Sponsor Role collaborator

Jin-tao Zhang

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Jin-tao Zhang

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jin-Tao Zhang, Phd

Role: PRINCIPAL_INVESTIGATOR

Beijing Normal University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Medical Ethics Committee of Zhenjiang Mental Health Center

Zhenjiang, Jiangsu, China

Site Status RECRUITING

State Key Laboratory of Cognitive Neuroscience and Learning

Beijing, , China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Jin-Tao Zhang, Phd

Role: CONTACT

15010233046

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Zi-Liang Wang, Phd

Role: primary

18395949625

Jin-Tao Zhang, Phd

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

The effect of rTMS in IGD

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.