The Effectiveness of tDCS on Internet Game Addiction

March 23, 2020 updated by: Jung-Seok Choi, Seoul National University Hospital

Randomized Double-blind Clinical Trial to Evaluate the Effectiveness of Transcranial Direct Current Stimulation (tDCS) on Internet Game Addiction

In this study, the investigators aimed to investigate the effect of transcranial direct current stimulation (tDCS) on clinical status of Internet game addiction. The clinical status of Internet game addiction includes severity of addiction symptom, subjective craving for gaming, response inhibition and cue reactivity. The investigators hypothesized that real stimulation with tDCS on the dorsolateral prefrontal cortex will have higher effectiveness on severity of addiction symptom, subjective craving for gaming, response inhibition and cue reactivity rather than sham stimulation with tDCS.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

31

Phase

  • Phase 2

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

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

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosis of Internet gaming disorder based on diagnostic criteria of Diagnostic and Statistical Manual of Mental Disorders (DSM)-5.

Exclusion Criteria:

  • History of seizure
  • History of significant head injury
  • Mental retardation
  • Schizophrenia
  • History of stroke

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
Active Comparator: tDCS with real stimulation
A total of 25 patients will be allocated into active comparator with real stimulation with tDCS.
Device: tDCS with real stimulation
tDCS is a non-invasive brain stimulation. Real stimulation includes 2mA current for 20 minutes per session. Two sessions a day for 5 consecutive days (Total: 10 sessions) will be applied.
Sham Comparator: tDCS with sham stimulation
A total of 25 patients will be allocated into sham comparator with sham stimulation with tDCS.
Device: tDCS with sham stimulation
Sham stimulation includes 0mA current for 20 minutes per session. Two sessions a day for 5 consecutive days (Total: 10 sessions) will be applied.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Young Internet Addiction Test (Y-IAT)
Time Frame: baseline
The Y-IAT is rated on a five-point scale. Total scores for all 20 items range from 20 to 100.
baseline
Young Internet Addiction Test (Y-IAT)
Time Frame: 1 week
The Y-IAT is rated on a five-point scale. Total scores for all 20 items range from 20 to 100.
1 week
Young Internet Addiction Test (Y-IAT)
Time Frame: 5 week
The Y-IAT is rated on a five-point scale. Total scores for all 20 items range from 20 to 100.
5 week
Young Internet Addiction Test (Y-IAT)
Time Frame: 25 week
The Y-IAT is rated on a five-point scale. Total scores for all 20 items range from 20 to 100.
25 week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Direction error and successful stop ratio in the Stop signal task
Time Frame: baseline, 5 weeks, 25 weeks
The stop signal task is a neurocognitive task for assessing response inhibition.
baseline, 5 weeks, 25 weeks
Barratt impulsiveness scale-11
Time Frame: baseline, 5 weeks, 25 weeks
Barratt impulsiveness scale-11 is a self-report questionnaire consisting of 30 items. Each question has a 4-point scale ranging from 1 (rarely/never) to 4 (almost always/always). This scale scores three subscales: attentional impulsiveness, motor impulsiveness, and nonplanning impulsiveness. The total score ranges from 30 to 120 and higher scores indicate greater impulsivity.
baseline, 5 weeks, 25 weeks
Anti-saccade error rate in the attentional bias task
Time Frame: baseline, 5 weeks, 25 weeks
The attentional bias task is measured by anti-saccade task using eye-tracking analysis for assessing attentional bias on Internet gaming stimuli.
baseline, 5 weeks, 25 weeks
Late positive potential in the cue reactivity event-related potential
Time Frame: baseline, 5 weeks, 25 weeks
Event-related potential measures with cue reactivity task
baseline, 5 weeks, 25 weeks
Visual analogue scale
Time Frame: baseline, 1 week, 5 weeks, 25 weeks
Subjective craving for Internet gaming ranging from 0 to 10. Higher score represents higher craving for gaming.
baseline, 1 week, 5 weeks, 25 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Collaborators

National Research Foundation of Korea
SMG-SNU Boramae Medical Center

Investigators

  • Principal Investigator: Jung-Seok Choi, MD, PhD, SMG-SNU Boramae Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

September 22, 2017

Primary Completion (Actual)

September 1, 2019

Study Completion (Actual)

October 8, 2019

Study Registration Dates

First Submitted

November 13, 2017

First Submitted That Met QC Criteria

November 15, 2017

First Posted (Actual)

November 20, 2017

Study Record Updates

Last Update Posted (Actual)

March 24, 2020

Last Update Submitted That Met QC Criteria

March 23, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 30-2017-10

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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