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Идёт набор NCT06466681

Changes in Attentional Control After a Focal Seizure.

— Наблюдательное Temporal Lobe Epilepsy Frontal Lobe Epilepsy Others Subtypes

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: All included subjects.
Кому может быть актуально
Состояния в реестре: Temporal Lobe Epilepsy, Frontal Lobe Epilepsy, Others Subtypes. Базовые параметры: 18 лет — 80 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 →

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Обзор

Epilepsy is frequently associated with cognitive and attentional disorders. Several studies have pointed out that there are modifications of brain activity in resting state during peri-ictal period in EEG and functional MRI. However, to date, no study has assessed the changes in attentional control after a seizure. The investigators hypothesize that a localized discharge is associated with a disorganization of the networks engaged in attentional control. In this regard, the investigators propose a prospective longitudinal study assessing the changes in attentional control after a focal seizure.

Вмешательства

  • Другое All included subjects
    Administration of the subtest of divided attention of the Test of Attentional Performance (TAP), recording of the event related potentiels N200 and P300, measure of the variation of power in several frequency bands (theta, alpha and beta) and measure of the high-resolution EEG connectivity during an attentional task at several time-points : a first time during interictal period (no seizure for more than 24 hours) and 1, 3, 6 and 24 hours after a focal seizure.

Первичные конечные точки

  • Subtest of divided attention of the Test of Attentional Performance (TAP) [Срок оценки: 24 hours]
Вторичные конечные точки (9)
  • N200 amplitude and latency [Срок оценки: 24 hours]
  • Strength of EEG functionnal connectivity during an attentional task (global and regional) [Срок оценки: 24 hours]
  • Variation of power in several frequency bands (theta, alpha and beta) during an attentional task. [Срок оценки: 24 hours]
  • Magnetic resonance imaging functional connectivity. [Срок оценки: up to 5 days]
  • Differences in N200 and P300 amplitude and latency recorded between different subgroups according to the epileptic focus. [Срок оценки: 24 hours]
  • P300 amplitude and latency [Срок оценки: 24 hours]
  • Differences in strength of EEG functional connectivity during an attentional task recorded between different subgroups according to the epileptic focus. [Срок оценки: 24 hours]
  • Differences in variation of power in several frequency bands (theta, alpha and beta) during an attentional task recorded between different subgroups according to the epileptic focus. [Срок оценки: 24 hours]
  • Differences in magnetic resonance imaging functional connectivity recorded between different subgroups according to the epileptic focus. [Срок оценки: 24 hours]

Критерии участия

Критерии включения

  • Age superior to 18 and under 80
  • Focal epilepsy with indication to pre-surgery work-up and 5 days programmed hospitalization dedicated to this work-up
  • Normal global cognitive performance (standard progressive Raven matrices score > 5th percentile)
  • Be affiliated to the social security system
  • Have signed an informed consent

Критерии исключения

  • Pregnancy or breastfeeding
  • Not able to give consent (Article 1121-8 of the CSP)
  • Vulnerable person
  • Being deprived of liberty by judicial or administrative decision (Article L 1121-6 of the CSP)
  • Guardianship
  • Have a high probability of not respecting the protocol or of abandoning the study
  • Absence of any epileptic seizure recorded during the hospitalization
  • Recurrent seizures preventing the recording of at least 24 hours without any seizure following a seizure.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Франция · 1 центр
  • University Hospital, — Lille

Идентификаторы

NCT: NCT06466681 · 2022_0762

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗