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

NCT ID: NCT04120714

Last Updated: 2024-08-23

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-06
• Study Completion Date: 2026-05-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Placebo tDCS group

Inactive tDCS

Group Type: PLACEBO_COMPARATOR

Placebo tDCS

Intervention Type: 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

Questionnaires

Intervention Type: 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

Active tDCS

Group Type: EXPERIMENTAL

Active tDCS

Intervention Type: DEVICE

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

Questionnaires

Intervention Type: 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

Interventions

Active tDCS

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

Intervention Type: 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

Intervention Type: DEVICE

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire Dijon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CHU de DIJON

Dijon, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Benoît TROJAK

Role: CONTACT

benoit.trojak@chu-dijon.fr

03.80.29.37.69 ext. +33

Facility Contacts

Benoît TROJAK

Role: primary

benoit.trojak@chu-dijon.fr

3 80 29 37 69 ext. +33

Other Identifiers

TROJAK 2019

Identifier Type: -

Identifier Source: org_study_id