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Recruiting NCT04120714

Efficacy of Transcranial Direct Current Stimulation (tDCS) in Patients Suffering From Pathological Use of Internet Gaming

No phase Interventional Pathological Use of Internet Games

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Active tDCS, Placebo tDCS, Questionnaires.
Who it may be relevant to
Registry conditions: Pathological Use of Internet Games. Basic parameters: from 12 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Efficacy of Transcranial Direct Current Stimulation (tDCS) in Patients Suffering From Pathological Use of Internet Gaming : Randomized, Controlled, Double-blind, Monocentric Pilot Study

Overview

The Internet has grown considerably in the last twenty years, and as a result, cases of excessive iinterney use have emerged. These cases, which have clinical similarities with substance addiction, involve the various activities related to the Internet (online gambling, discussion forums, online networking, e-mail, pornography, shopping, etc.). However, to date, only the pathological use of Internet gaming (PUIG) is referenced in the 5th edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5, section III). In PUIG, an individual loses control when gambling online. He/she typically spends 8 to 10 hours on this activity, sometimes without eating or sleeping. Usual obligations, such as school or work, or family obligations are neglected. PUIG can cause great psychological and social suffering. Neurological complications (epilepsy) and deaths (cardiac arrest) related to PUIG have also been reported. These situations are all the more dramatic because they often affect adolescents and young adults. In Asia, PUIG has become a public health problem. To date, no treatment has been validated for this disorder. Non-invasive brain stimulation (NIBS) techniques can modulate neural activity in the dorsolateral prefrontal cortex (DLPFC). This modulation makes it possible to reduce addictive behaviours through different mechanisms (reduction of craving, impulsivity, and decision-making disorders). These techniques could be effective for PUIG.

Interventions

  • Device Active tDCS
    active D.C. transcranial stimulation (delivers a low current (1 to 2 mA)) for 10 to 30 minutes, during 5 sessions
  • Device Placebo tDCS
    inactive DC transcranial stimulation (delivering a non-significant current at the beginning and end of the stimulation, simulating active stimulation) for 10 to 30 minutes, during 5 sessions
  • Other Questionnaires
    * visual analogue scale (VAS) * impulsivity scale: Barratt Impulsiveness Scale - version 11 (BIS-11) * Decision-making scales: Iowa Gambling Task (IGT) and Balloon Analogue Risk Task (BART) * Go-No go test * HAM-D scale * SF-12 quality of life scale

Primary outcome measures

  • Evolution of scores on the IAT scale (Internet Addiction Test) [Time frame: 4 weeks after tDCS treatment]

Eligibility criteria

Inclusion criteria

  • Patient aged ≥ 12 years old
  • Patient and/or parents who have given oral consent
  • Patient with PUIG (DSM-5 criteria)
  • Patient that is motivated and willing to reduce or stop internet gaming

Exclusion criteria

  • a person who is not affiliated to or not a beneficiary of a social security scheme
  • Patient with severe chronic psychiatric comorbidity (schizophrenia, paranoia, chronic hallucinatory psychosis) and bipolar disorder types I and II
  • Patient with a gambling addiction
  • Patient who has had a recent change (< 1 month) in the prescription of psychotropic treatment
  • Patient with an addiction to a psychoactive substance other than tobacco
  • Patient receiving psychiatric care without consent or legal protection (guardianship, curatorship)
  • Minor patient without parental consent for care
  • Patient with severe heart, kidney, liver or lung failure
  • Patient with a contraindication to the practice of tDCS: metal parts, medical devices implanted in the brain
  • Pregnancy or breastfeeding in progress (negative pregnancy test)
  • Patient unable to commit to a three-month follow-up

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

France · 1 center
  • CHU de DIJON — Dijon

Identifiers

NCT: NCT04120714 · TROJAK 2019

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗