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

NCT04120714 | Recruiting

• 1 other identifier: TROJAK 2019
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pathological Use of Internet Games

Outcome Measures

Primary Outcomes (1)

• Evolution of scores on the IAT scale (Internet Addiction Test)

  Evolution of scores on the IAT (Internet Addiction Test) scale 4 weeks after treatment with tDCS (5 sessions) compared to the 4 weeks preceding brain stimulation

  4 weeks after tDCS treatment

Study Arms (2)

Active tDCS group

EXPERIMENTAL

Active tDCS

Device: Active tDCS; Other: Questionnaires

Placebo tDCS group

PLACEBO COMPARATOR

Inactive tDCS

Device: Placebo tDCS; Other: Questionnaires

Interventions

Active tDCS DEVICE

active D.C. transcranial stimulation (delivers a low current (1 to 2 mA)) for 10 to 30 minutes, during 5 sessions

Active tDCS group

Placebo tDCS DEVICE

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

Placebo tDCS group

Questionnaires OTHER

* 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

Active tDCS group; Placebo tDCS group

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire Dijon: lead

Study Sites (1)

CHU de DIJON

Dijon, 21079, France

RECRUITING

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Central Study Contacts

Benoît TROJAK

CONTACT

03.80.29.37.69; benoit.trojak@chu-dijon.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2019
• First Posted: October 9, 2019
• Study Start: January 6, 2020
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: April 13, 2026

Record last verified: 2026-04

Locations

FR (1)