Efficacy of Transcranial Direct Current Stimulation (tDCS) in Patients Suffering From Pathological Use of Internet Gaming : Randomized, Controlled, Double-blind, Monocentric Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Evolution of scores on the IAT scale (Internet Addiction Test)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Active tDCS group
Active tDCS
干预措施: Active tDCS (Device)
Active tDCS group
Active tDCS
干预措施: Questionnaires (Other)
Placebo tDCS group
Inactive tDCS
干预措施: Placebo tDCS (Device)
Placebo tDCS group
Inactive tDCS
干预措施: Questionnaires (Other)
结局指标
主要结局
Evolution of scores on the IAT scale (Internet Addiction Test)
时间窗: 4 weeks after tDCS treatment
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
次要结局
未报告次要终点