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The Effectiveness of tDCS on Internet Game Addiction

Primary Purpose

Addiction, Internet Gaming Disorder

Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
tDCS with real stimulation
tDCS with sham stimulation
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Addiction focused on measuring Internet game addiction, Internet gaming disorder, transcranial direct current stimulation, response inhibition, craving, cue reactivity

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • SMG-SNU Boramae Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

tDCS with real stimulation

tDCS with sham stimulation

Arm Description

A total of 25 patients will be allocated into active comparator with real stimulation with tDCS.

A total of 25 patients will be allocated into sham comparator with sham stimulation with tDCS.

Outcomes

Primary Outcome Measures

Young Internet Addiction Test (Y-IAT)
The Y-IAT is rated on a five-point scale. Total scores for all 20 items range from 20 to 100.
Young Internet Addiction Test (Y-IAT)
The Y-IAT is rated on a five-point scale. Total scores for all 20 items range from 20 to 100.
Young Internet Addiction Test (Y-IAT)
The Y-IAT is rated on a five-point scale. Total scores for all 20 items range from 20 to 100.
Young Internet Addiction Test (Y-IAT)
The Y-IAT is rated on a five-point scale. Total scores for all 20 items range from 20 to 100.

Secondary Outcome Measures

Direction error and successful stop ratio in the Stop signal task
The stop signal task is a neurocognitive task for assessing response inhibition.
Barratt impulsiveness scale-11
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.
Anti-saccade error rate in the attentional bias task
The attentional bias task is measured by anti-saccade task using eye-tracking analysis for assessing attentional bias on Internet gaming stimuli.
Late positive potential in the cue reactivity event-related potential
Event-related potential measures with cue reactivity task
Visual analogue scale
Subjective craving for Internet gaming ranging from 0 to 10. Higher score represents higher craving for gaming.

Full Information

First Posted
November 13, 2017
Last Updated
March 23, 2020
Sponsor
Seoul National University Hospital
Collaborators
National Research Foundation of Korea, SMG-SNU Boramae Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03347643
Brief Title
The Effectiveness of tDCS on Internet Game Addiction
Official Title
Randomized Double-blind Clinical Trial to Evaluate the Effectiveness of Transcranial Direct Current Stimulation (tDCS) on Internet Game Addiction
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
September 22, 2017 (Actual)
Primary Completion Date
September 1, 2019 (Actual)
Study Completion Date
October 8, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
Collaborators
National Research Foundation of Korea, SMG-SNU Boramae Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Addiction, Internet Gaming Disorder
Keywords
Internet game addiction, Internet gaming disorder, transcranial direct current stimulation, response inhibition, craving, cue reactivity

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Patients with internet gaming disorder will be randomly allocated into 1) actual real stimulation with tDCS group, and 2) sham stimulation with tDCS group.
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
tDCS with real stimulation
Arm Type
Active Comparator
Arm Description
A total of 25 patients will be allocated into active comparator with real stimulation with tDCS.
Arm Title
tDCS with sham stimulation
Arm Type
Sham Comparator
Arm Description
A total of 25 patients will be allocated into sham comparator with sham stimulation with tDCS.
Intervention Type
Device
Intervention Name(s)
tDCS with real stimulation
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
tDCS with sham stimulation
Intervention Description
Sham stimulation includes 0mA current for 20 minutes per session. Two sessions a day for 5 consecutive days (Total: 10 sessions) will be applied.
Primary Outcome Measure Information:
Title
Young Internet Addiction Test (Y-IAT)
Description
The Y-IAT is rated on a five-point scale. Total scores for all 20 items range from 20 to 100.
Time Frame
baseline
Title
Young Internet Addiction Test (Y-IAT)
Description
The Y-IAT is rated on a five-point scale. Total scores for all 20 items range from 20 to 100.
Time Frame
1 week
Title
Young Internet Addiction Test (Y-IAT)
Description
The Y-IAT is rated on a five-point scale. Total scores for all 20 items range from 20 to 100.
Time Frame
5 week
Title
Young Internet Addiction Test (Y-IAT)
Description
The Y-IAT is rated on a five-point scale. Total scores for all 20 items range from 20 to 100.
Time Frame
25 week
Secondary Outcome Measure Information:
Title
Direction error and successful stop ratio in the Stop signal task
Description
The stop signal task is a neurocognitive task for assessing response inhibition.
Time Frame
baseline, 5 weeks, 25 weeks
Title
Barratt impulsiveness scale-11
Description
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.
Time Frame
baseline, 5 weeks, 25 weeks
Title
Anti-saccade error rate in the attentional bias task
Description
The attentional bias task is measured by anti-saccade task using eye-tracking analysis for assessing attentional bias on Internet gaming stimuli.
Time Frame
baseline, 5 weeks, 25 weeks
Title
Late positive potential in the cue reactivity event-related potential
Description
Event-related potential measures with cue reactivity task
Time Frame
baseline, 5 weeks, 25 weeks
Title
Visual analogue scale
Description
Subjective craving for Internet gaming ranging from 0 to 10. Higher score represents higher craving for gaming.
Time Frame
baseline, 1 week, 5 weeks, 25 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jung-Seok Choi, MD, PhD
Organizational Affiliation
SMG-SNU Boramae Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
SMG-SNU Boramae Medical Center
City
Seoul
ZIP/Postal Code
07061
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34296150
Citation
Lee JY, Jang JH, Choi AR, Chung SJ, Kim B, Park M, Oh S, Jung MH, Choi JS. Neuromodulatory Effect of Transcranial Direct Current Stimulation on Resting-State EEG Activity in Internet Gaming Disorder: A Randomized, Double-Blind, Sham-Controlled Parallel Group Trial. Cereb Cortex Commun. 2021 Jan 4;2(1):tgaa095. doi: 10.1093/texcom/tgaa095. eCollection 2021.
Results Reference
derived

Learn more about this trial

The Effectiveness of tDCS on Internet Game Addiction

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