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CompletedNCT03347643Updated Mar 24, 2020

The Effectiveness of tDCS on Internet Game Addiction

A Phase 2 interventional study of tDCS with real stimulation and tDCS with sham stimulation in Addiction and Internet Gaming Disorder, sponsored by Seoul National University Hospital. Completed at 1 site in Korea, Republic of. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2020-03-24.

Sponsored by Seoul National University Hospital · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
31
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Addiction
  • Internet Gaming Disorder

Keywords

  • Internet game addiction
  • Internet gaming disorder
  • transcranial direct current stimulation
  • response inhibition
  • craving
  • cue reactivity
03

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • History of seizure
  • History of significant head injury
  • Mental retardation
  • Schizophrenia
  • History of stroke
04

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
31 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • DevicetDCS 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.

  • DevicetDCS 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.

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: baseline

  2. 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.

    Time frame: 1 week

  3. 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.

    Time frame: 5 week

  4. 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.

    Time frame: 25 week

Secondary outcomes

  1. Direction error and successful stop ratio in the Stop signal task

    The stop signal task is a neurocognitive task for assessing response inhibition.

    Time frame: baseline, 5 weeks, 25 weeks

  2. 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.

    Time frame: baseline, 5 weeks, 25 weeks

  3. 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.

    Time frame: baseline, 5 weeks, 25 weeks

  4. Late positive potential in the cue reactivity event-related potential

    Event-related potential measures with cue reactivity task

    Time frame: baseline, 5 weeks, 25 weeks

  5. Visual analogue scale

    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

06

Study locations

1 site
  • SMG-SNU Boramae Medical Center
    Seoul, 07061, Korea, Republic of
07

References and documents

Publications

  • 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. PubMed 34296150 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT03347643
Lead sponsor
Seoul National University Hospital
Collaborators
National Research Foundation of Korea, SMG-SNU Boramae Medical Center
Responsible party
Jung-Seok Choi (Clinical associate professor, Seoul National University Hospital) — Principal investigator
First posted
Nov 20, 2017
Start date
Sep 22, 2017
Primary completion
Sep 1, 2019
Completion
Oct 8, 2019
Last update
Mar 24, 2020

Study contacts

Jung-Seok Choi, MD, PhD
principal investigator · SMG-SNU Boramae Medical Center

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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