The Effectiveness of tDCS on Internet Game Addiction

Sponsor

Seoul National University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT03347643

Collaborator

National Research Foundation of Korea (Other), SMG-SNU Boramae Medical Center (Other)

Enrollment

Location

Arms

24.5

Actual Duration (Months)

1.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Addiction Internet Gaming Disorder	Device: tDCS with real stimulation Device: tDCS with sham stimulation	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

31 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention 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.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:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Sep 22, 2017

Actual Primary Completion Date :

Sep 1, 2019

Actual Study Completion Date :

Oct 8, 2019

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Young Internet Addiction Test (Y-IAT) [baseline]
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) [1 week]
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) [5 week]
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) [25 week]
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 [baseline, 5 weeks, 25 weeks]
The stop signal task is a neurocognitive task for assessing response inhibition.
Barratt impulsiveness scale-11 [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.
Anti-saccade error rate in the attentional bias task [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.
Late positive potential in the cue reactivity event-related potential [baseline, 5 weeks, 25 weeks]
Event-related potential measures with cue reactivity task
Visual analogue scale [baseline, 1 week, 5 weeks, 25 weeks]
Subjective craving for Internet gaming ranging from 0 to 10. Higher score represents higher craving for gaming.