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Идёт набор NCT04120714

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

Без фазы С лечением Pathological Use of Internet Games

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Active tDCS, Placebo tDCS, Questionnaires.
Кому может быть актуально
Состояния в реестре: Pathological Use of Internet Games. Базовые параметры: от 12 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Франция
Следующий шаг
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Официальное название

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

Обзор

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.

Вмешательства

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

Первичные конечные точки

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

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Двойное слепое
Основная цель
Лечение

Центры проведения

Франция · 1 центр
  • CHU de DIJON — Dijon

Идентификаторы

NCT: NCT04120714 · TROJAK 2019

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗