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Идёт набор NCT05296720

EEG and Behavioral Correlates of Temporal Prediction in the Tactile Modality in Schizophrenia

Без фазы С лечением Schizophrenia

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: Tactile stimulation.
Кому может быть актуально
Состояния в реестре: Schizophrenia. Базовые параметры: 18 лет — 60 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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Обзор

Patients with schizophrenia have disturbances in their sense of self, particularly their bodily self. Disorders of the sense of self are central to schizophrenia and are of interest because they are thought to be present prior to the development of the disorder, when only a few attenuated symptoms signal a risk of developing psychosis. Finding markers related to the sense of self would make it possible to predict which subjects, among those with minimal psychotic symptoms, will develop psychosis, and thus to better adapt management. Disturbances in the experience of the passage of time that accompany disturbances in the sense of self have been described particularly in subjects at risk of developing psychosis, and would predict the onset of the pathology. However, as with alterations in the sense of self, it can be difficult to get patients to describe their disturbances in the experience of time, and objective measures are required to facilitate detection of these disturbances. In the present protocol an objective measure of temporal perception mechanisms will be tested in relation to the sense of self. The tests used in the protocol assess subjects' abilities to benefit from the passage of time and to use these abilities to predict and prepare for the occurrence of an event. The investigators have previously shown that patients with impaired bodily sense of self do not benefit from the passage of time to prepare themselves to process information in the future. The present protocol is aimed at developing a measure more sensitive to the patients' disorders by adding tactile measures.

Подробное описание

Patients with schizophrenia have disturbances in their sense of self, particularly their bodily self. Disorders of the sense of self are central to schizophrenia and are of interest because they are thought to be present prior to the development of the disorder, when only a few attenuated symptoms signal a risk of developing psychosis. Finding markers related to the sense of self would make it possible to predict which subjects, among those with minimal psychotic symptoms, will develop psychosis, and thus to better adapt management. Disturbances in the experience of the passage of time that accompany disturbances in the sense of self have been described particularly in subjects at risk of developing psychosis, and would predict the onset of the pathology. However, as with alterations in the sense of self, it can be difficult to get patients to describe their disturbances in the experience of time, and objective measures are required to facilitate detection of these disturbances. In the present protocol an objective measure of temporal perception mechanisms will be tested in relation to the sense of self.

The tests used in the protocol assess subjects' abilities to benefit from the passage of time and to use these abilities to predict and prepare for the occurrence of an event. The investigators have previously shown that patients with impaired bodily sense of self do not benefit from the passage of time to prepare themselves to process information in the future. The present protocol is aimed at developing a measure more sensitive to the patients' disorders by adding tactile measures.

Вмешательства

  • Поведенческое Tactile stimulation
    Participants are asked to react as fast as possible to a tactile stimulation

Первичные конечные точки

  • measure of movement speed [Срок оценки: month 2]
Вторичные конечные точки (1)
  • Electroencephalographic measure [Срок оценки: month 2]

Критерии участия

Критерии включения

  • Male or Female;
  • Age between 18 and 60 years inclusive;
  • Subject who has dated and signed the consent form (guardian or custodian prior to the commencement of any trial-related procedures if applicable);
  • Enrolled in a social security plan or beneficiary of such a plan.

Критерии исключения

  • Psychoactive substance use disorders (as defined by DSM-V);
  • Use of benzodiazepines (in the period prior to inclusion, for a duration equivalent to 5 half-lives of the product), cannabis (in the 2 months prior to inclusion; use of cannabis (THC) will be verified with a urine dipstick) or hallucinogenic substances (in the period prior to inclusion, for a duration equivalent to 5 half-lives of the product);
  • Neurological pathology or sequelae;
  • Attention deficit hyperactivity disorder (ADHD);
  • A borderline personality disorder;
  • Disabling sensory disorders;
  • Person deprived of liberty or under court protection;
  • Pregnant, parturient or nursing woman;
  • Subject in a period of exclusion as defined by another clinical study.

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Нерандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Фундаментальное исследование

Центры проведения

Франция · 1 центр
  • Anne GIERSCH — Strasbourg

Идентификаторы

NCT: NCT05296720 · 021-A02434-37

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗