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Clinical Trials/NCT03347643
NCT03347643CompletedPhase 2

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

Seoul National University Hospital1 site in 1 country31 target enrollmentStarted: September 22, 2017Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Phase 2
Status
Completed
Enrollment
31
Locations
1
Primary Endpoint
Young Internet Addiction Test (Y-IAT)

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Eligibility Criteria

Ages
18 Years to 50 Years (Adult)
Sex
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

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

Arms & Interventions

tDCS with real stimulation

Active Comparator

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

Intervention: tDCS with real stimulation (Device)

tDCS with sham stimulation

Sham Comparator

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

Intervention: tDCS with sham stimulation (Device)

Outcomes

Primary Outcomes

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.

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.

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.

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.

Secondary Outcomes

  • Direction error and successful stop ratio in the Stop signal task(baseline, 5 weeks, 25 weeks)
  • Barratt impulsiveness scale-11(baseline, 5 weeks, 25 weeks)
  • Anti-saccade error rate in the attentional bias task(baseline, 5 weeks, 25 weeks)
  • Late positive potential in the cue reactivity event-related potential(baseline, 5 weeks, 25 weeks)
  • Visual analogue scale(baseline, 1 week, 5 weeks, 25 weeks)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Jung-Seok Choi

Clinical associate professor

Seoul National University Hospital

Study Sites (1)

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