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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03347643
Other study ID # 30-2017-10
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date September 22, 2017
Est. completion date October 8, 2019

Study information

Verified date March 2020
Source Seoul National University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 31
Est. completion date October 8, 2019
Est. primary completion date September 1, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 50 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.
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.

Locations

Country Name City State
Korea, Republic of SMG-SNU Boramae Medical Center Seoul

Sponsors (3)

Lead Sponsor Collaborator
Seoul National University Hospital National Research Foundation of Korea, SMG-SNU Boramae Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. baseline
Primary 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. 1 week
Primary 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. 5 week
Primary 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. 25 week
Secondary Direction error and successful stop ratio in the Stop signal task The stop signal task is a neurocognitive task for assessing response inhibition. baseline, 5 weeks, 25 weeks
Secondary 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. baseline, 5 weeks, 25 weeks
Secondary 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. baseline, 5 weeks, 25 weeks
Secondary Late positive potential in the cue reactivity event-related potential Event-related potential measures with cue reactivity task baseline, 5 weeks, 25 weeks
Secondary Visual analogue scale Subjective craving for Internet gaming ranging from 0 to 10. Higher score represents higher craving for gaming. baseline, 1 week, 5 weeks, 25 weeks
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