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Идёт набор NCT05719844

Interest of an Attentional Evaluation by a Computerized Battery in the Management of Concussion in Young Rugby Players

Без фазы С лечением Concussion, Brain

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: Neuropsychological tests.
Кому может быть актуально
Состояния в реестре: Concussion, Brain. Базовые параметры: 11 лет — 25 лет · Мужчины.
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

The goal of this study is to test the ability of a computerized neuropsychological battery to identify attentional disorders resulting from a concussion occurring during the practice of rugby. Thirty young people with a concussion (11-25 years old) will take several neuropsychological tests. Researchers will compare their results with those of young athletes without concussion to see the effect of concussion.

Подробное описание

The objective is to carry out a complete neuropsychological assessment, detailing the attentional and executive aspects using the TAP computerized battery. In addition, various paper-and-pencil tests, standardized in French, more commonly used in the context of neuropsychological data related to concussions in athletes, will also be administered. These assess processing speed, short-term memory and auditory-verbal working memory capacity, episodic memory and selective attention. This preliminary study would make it possible to shed light on the links that may exist between performance in the various tests proposed and the characteristics inherent in the symptomatology of concussion. Furthermore, it seems relevant to compare the results of computerized tests with other paper-and-pencil tests but also with the performance of individuals who have no history of concussion with the practice of a non-contact sport.

The results of this study would make it possible in practice to have a neuropsychological assessment more specific to cerebral concussion, with a potentially reduced consultation time due to the use of more sensitive tools, and therefore, an earlier rehabilitative intervention.

Вмешательства

  • Диагностический тест Neuropsychological tests
    List of neuropsychological tests: * Matrix reasoning * D2-R * Coding * Symbol search * Digit span * Alertness (computerized TAP battery) * Divided Attention (computerized TAP battery) * Go / No go (computerized TAP battery) * Incompatibility (computerized TAP battery) * Working memory (computerized TAP battery) * 16-item Free and Cued Recall or Stories subtest of the Children Memory Scale (CMS) for children only (\< 17 years old) * complex figure of the memory efficiency battery 144 or Word pai

Первичные конечные точки

  • Alertness time [Срок оценки: At inclusion]
  • Alertness error [Срок оценки: At inclusion]
  • Divided Attention time [Срок оценки: At inclusion]
  • Divided Attention error [Срок оценки: At inclusion]
  • Go/No-go time [Срок оценки: At inclusion]
  • Go/No-go error [Срок оценки: At inclusion]
  • Incompatibility time [Срок оценки: At inclusion]
  • Incompatibility error [Срок оценки: At inclusion]
  • Working Memory time [Срок оценки: At inclusion]
  • Working Memory error [Срок оценки: At inclusion]
Вторичные конечные точки (12)
  • Matrix reasoning [Срок оценки: At inclusion]
  • Coding [Срок оценки: At inclusion]
  • Symbol [Срок оценки: At inclusion]
  • Digit span [Срок оценки: At inclusion]
  • 16-item free and cued recall [Срок оценки: At inclusion]
  • Complex figure [Срок оценки: At inclusion]
  • Stories [Срок оценки: At inclusion]
  • Word pairs [Срок оценки: At inclusion]
  • D2-R error [Срок оценки: At inclusion]
  • D2-R time [Срок оценки: At inclusion]
  • Sociodemographic data [Срок оценки: At inclusion]
  • Headaches [Срок оценки: At inclusion]

Критерии участия

Критерии включения

  • Patients :
  • concussion in the context of the practice of rugby
  • French or reading French without help
  • Controls :
  • no concussion
  • practicing a non-contact sport (athletics, rowing, badminton, capoeira, circus, running, crossfit, cycling, dancing, climbing, fencing, fitness, golf, gymnastics, bodybuilding, swimming, skating, Qi Gong, Taï chi, tennis, table tennis, shooting, trail running, volleyball, water polo) within a sports association
  • age matched to patient (+/- 1 year)
  • study level matched to patient (+/- 1 year)
  • French or reading French without help

Критерии исключения

  • Patients :
  • Legal protection measure
  • Other neurological or psychiatric pathologies prior to concussion episodes
  • Diagnosis of a neurodevelopmental disorder in childhood
  • Score less than or equal to 5/19 on the "Matrix" subtest (intellectual retardation)
  • Addictive behaviors
  • Current major depressive disorder or treated with antidepressants or benzodiazepines for less than 3 months
  • Severe visual or motor problems that may interfere with the performance of the tests
  • Controls :
  • Legal protection measure
  • History of proven concussion
  • Other neurological or psychiatric pathologies
  • Diagnosis of a neurodevelopmental disorder in childhood
  • Score less than or equal to 5/19 on the "Matrix" subtest (intellectual retardation)
  • Addictive behaviors
  • Current major depressive episode or treated with antidepressants or benzodiazepines for less than 3 months
  • Severe visual or motor problems that may interfere with the performance of the tests

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Диагностика

Центры проведения

Франция · 1 центр
  • CHU de Clermont-Ferrand — Clermont-Ferrand

Идентификаторы

NCT: NCT05719844 · AOI 2021 VIDAL

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗