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Идёт набор NCT06036316

Study of Language Disorders and Interactions Between Mnesic Capabilities and Semantic Competencies in Patients With Psychosis

Без фазы С лечением Psychosis Schizophrenia At-risk Mental State Language Disorders

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: Language assessment, TLC - Scale for the Assessment of Thought, Language, and Communication, MINI - Mini International Neuropsychiatric Interview, CAST - Cannabis Abuse Screening Test.
Кому может быть актуально
Состояния в реестре: Psychosis, Schizophrenia, At-risk Mental State, Language Disorders. Базовые параметры: 16 лет — 55 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
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Обзор

This research concerns the study of language disorders of patients present in the spectrum of psychosis. It is indeed accepted that psychotic disorders are associated with language difficulties, which are only poorly highlighted thanks to reusable tools in clinical practice. These language disorders impact communication, and concern many linguistic domains, thus covering phonology, lexicon, semantics, morphosyntax and pragmatics. It therefore seems relevant to characterize these language disorders and to assess to what extent they interact with the other symptoms of the pathology, in particular the course of the thought disorder and the neuropsychological symptoms. In addition, this study is particularly interested in the interactions between working memory capacities and those related to syntax. It is intended for different patients suffering from psychotic disorders of different intensities, treated in the Psychotherapeutic Center of Nancy. Patients suffering from at-risk mental state (ARMS), first episode of psychosis (FEP) or schizophrenia will benefit from a complete language assessment, evaluating each domain mentioned above, on the expressive and understanding sides. The results of the language assessment will be compared with those of a control group in the same tests. They will also be analyzed with regard to the neuropsychological and psychiatric elements noted in the patient's medical file, in order to highlight possible associations between language skills, neuropsychological and psychiatric symptoms in this patient population.

Вмешательства

  • Поведенческое Language assessment
    The proposed speech and language therapy assessment will consist of a battery of standardized tests that speech and language therapists can use to assess the language skills in reception and expression of adult patients. Concerning the assessment of the interactions between working memory and semantic abilities, a complete protocol has been developed.
  • Поведенческое TLC - Scale for the Assessment of Thought, Language, and Communication
    This scale is frequently used in psychiatry and is used to measure formal thought disorders in patients suffering from psychosis. As part of this study, it will be intended for patients suffering from schizophrenia
  • Поведенческое MINI - Mini International Neuropsychiatric Interview
    This scale corresponds to a rapid assessment of the psychiatric and psychological state of patients. It helps detect any psychiatric disorders. Here, it will be offered to volunteers who are part of the control group.
  • Комбинированный продукт CAST - Cannabis Abuse Screening Test
    The purpose of this questionnaire is to approximate participants' cannabis consumption and to assess any disorders associated with cannabis consumption. It will be offered to all participants, patients and healthy controls

Первичные конечные точки

  • language assessment performance score [Срок оценки: day 1]
Вторичные конечные точки (12)
  • CAARMS Speech Disorganization Severity Score [Срок оценки: day 1]
  • Severity score for the disordered items of the course of thought of the SPI-A [Срок оценки: day 1]
  • Severity score for speech disorganization and formal thought disorders on the TLC Scale [Срок оценки: day 1]
  • Neuropsychological rating scales scores (CVLT) [Срок оценки: day 1]
  • Neuropsychological rating scales scores (CVLT total) [Срок оценки: day 1]
  • Neuropsychological rating scales scores (Front and back spans) [Срок оценки: day 1]
  • Neuropsychological rating scales scores (Front and back spans 2) [Срок оценки: day 1]
  • Neuropsychological rating scales scores (TAP 1) [Срок оценки: day 1]
  • Neuropsychological rating scales scores (TAP 2) [Срок оценки: day 1]
  • Neuropsychological rating scales scores (TAP 3) [Срок оценки: day 1]
  • Neuropsychological rating scales scores (TAP 4) [Срок оценки: day 1]
  • Neuropsychological rating scales scores (TAP 5) [Срок оценки: day 1]

Критерии участия

Критерии включения

  • All Groups:
  • Patient affiliated or entitled to a social security scheme
  • Patient having received informed information on the study and having co-signed, with the investigator, a consent to participate in the study
  • For minor participants, at least one of the parents or holders of parental authority having been informed of the study, having received the information note relating to it and not having objected to the participation of his or her child
  • Native language: French
  • ARMS and FEP Patient Group:
  • Age between 16 and 35 years old
  • Present the criteria for EMRP or FEP as defined by the Comprehensive Assessment of At Risk Mental State (CAARMS) or present the criteria for Disorders of the course of thought to the items of the Schizophrenia Proneness Instrument (SPI-A)
  • Patients with schizophrenia group:
  • Age between 16 and 55 years old
  • Patient with diagnostic criteria for schizophrenia, as defined by DSM V (American Psychiatric Association, 2015)
  • Present the criteria for Disorganization of Speech and Formal Thought Disorder as defined by the Thinking, Language and Communication (TLC) Rating Scale.
  • Healthy Volunteers Group:
  • Age between 16 and 55 years old
  • Parental authorization (of both parents) to participate in the study for minor patients

Критерии исключения

  • All groups:
  • Pregnant, parturient or nursing mother
  • Person deprived of liberty by a judicial or administrative decision
  • Person in a life-threatening emergency
  • Adult subject to a legal protection measure (guardianship, curatorship, safeguard of justice)
  • Adult person unable to express their consent and who is not the subject of a legal protection measure
  • Impairment of the subject making it difficult, if not impossible, for them to participate in the trial or to understand the information given to them
  • Abuse or dependence of any substance according to DSM V criteria excluding cannabis
  • Healthy Volunteers Group:
  • Evolving psychiatric pathology (axis I of the DSM IV, measured at the MINI) excluding anxiety disorder
  • Presence of developmental disorder of oral language or written language revealed on clinical examination.

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
Открытое
Основная цель
Диагностика

Центры проведения

Франция · 1 центр
  • Centre Psychothérapeutique de Nancy — Laxou

Публикации

  • Majerus S. Language repetition and short-term memory: an integrative framework. Front Hum Neurosci. 2013 Jul 12;7:357. doi: 10.3389/fnhum.2013.00357. eCollection 2013. PMID 23874280

Идентификаторы

NCT: NCT06036316 · 2023-A00949-36

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗