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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Pathological Use of Internet Games
• Intervention / Treatment: Device: Active tDCS; Other: Questionnaires; Device: Placebo tDCS

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Benoît TROJAK; Phone Number: +33 03.80.29.37.69; Email: benoit.trojak@chu-dijon.fr

Study Locations

• France
  • Dijon, France, 21079
    • Recruiting
    • CHU de Dijon
    • Contact: Benoît TROJAK; Phone Number: +33 3 80 29 37 69; Email: benoit.trojak@chu-dijon.fr
    • Principal Investigator: Benoît TROJAK

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active tDCS group; Active tDCS	Device: Active tDCS; active D.C. transcranial stimulation (delivers a low current (1 to 2 mA)) 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
Placebo Comparator: Placebo tDCS group; Inactive tDCS	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; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire Dijon

Study record dates

Study Major Dates

• Study Start (Actual): January 6, 2020
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): May 1, 2026

Study Registration Dates

• First Submitted: October 8, 2019
• First Submitted That Met QC Criteria: October 8, 2019
• First Posted (Actual): October 9, 2019

Study Record Updates

• Last Update Posted (Actual): February 8, 2024
• Last Update Submitted That Met QC Criteria: February 7, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: TROJAK 2019

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No