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Идёт набор NCT06967935

Sleep and Rehearsal-Driven Memory in Epilepsy

— Наблюдательное Epilepsy Memory Consolidation

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: Cognitive memory task on a computer, Eye tracking, Questionnaires on task-related fatigue, Questionnaire on task difficulty.
Кому может быть актуально
Состояния в реестре: Epilepsy, Memory Consolidation. Базовые параметры: 18 лет — 65 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

Rehearsal-Induced Memory Consolidation and Its Modulation by Sleep in People With Epilepsy

Обзор

Memory consolidation transforms unstable memory traces into lasting representations, a process enhanced by both sleep and rehearsal during learning. Rehearsal is thought to accelerate consolidation by inducing memory reactivations that resemble those occurring during sleep. However, the respective mechanisms of sleep- and rehearsal-induced consolidation-and their potential interactions-remain poorly understood, especially in patients with temporal lobe epilepsy, where rehearsal might help compensate for memory deficits linked to hippocampal dysfunction, and where sleep may exacerbate epileptic activity. The CORESOM-EPI study aims to compare the effects of rehearsal and sleep on memory consolidation in patients undergoing video-EEG monitoring. Participants will learn "object-place" associations under two conditions (single versus repeated encoding), with memory tested immediately and again after a 12-hour delay. This delay will either include a full day awake or a night of sleep, allowing direct comparison of sleep- and rehearsal-related consolidation effects. Each participant will perform the task twice, with "wake" and "sleep" condition, in a balanced order. As a preliminary phase of the CRIMES study (ANR-DFG 2024), CORESOM-EPI will help assess how sleep and rehearsal influence memory consolidation in epilepsy. It will also serve to adapt the behavioral task for clinical use, paving the way for a future intracranial EEG investigations that will explore the neural networks involved and their modulation by epileptic activity.

Вмешательства

  • Другое Cognitive memory task on a computer
    Encoding: (1) Participants will learn 60 associations between pairs of items (cue and target) that are presented sequentially at unique locations on a screen, in a given context. 30 pairs are presented once, and 30 pairs are presented repeatedly (4 times). (2) After learning, the first recall phase begins after a short delay of 30 minutes: 50% of the pairs are tested in a similar way, this time with an assessment of contextual memory. (3) The remaining 50% of pairs are tested after a 12-hour d
  • Другое Eye tracking
    Eye-tracking will be carried out during the task to ensure that participants are focused on the task (quantification of the number and duration of eye fixations in the area of interest corresponding to the target presentation)
  • Другое Questionnaires on task-related fatigue
    Questionnaire on task-related fatigue (Likert-scale) will be completed by participants between blocks of items during the task
  • Другое Questionnaire on task difficulty
    Questionnaires on task difficulty (Likert-scale) will be completed by participants at the end of the task
  • Другое Karolinska scale
    Participants' state of sleepiness will be assessed at the beginning of each stage (encoding, immediate recall, delayed recall) using the Karolinska sleepiness scale

Первичные конечные точки

  • Change in the percentage of object categories recalled (vs. not recalled) between immediate (30 min after learning) and delayed (12h after learning) recall for rehearsed versus non-rehearsed items. [Срок оценки: Day 2]
  • Change in the percentage of object categories recalled (vs. not recalled) between immediate (30 min after learning) and delayed (12h after learning) recall for rehearsed versus non-rehearsed items. [Срок оценки: Day 2 + 12 hours]
  • Change in the percentage of object categories recalled (vs. not recalled) between immediate (30 min after learning) and delayed (12h after learning) recall for rehearsed versus non-rehearsed items. [Срок оценки: Day 2 + 36 hours]
  • Change in the percentage of object categories recalled (vs. not recalled) between immediate (30 min after learning) and delayed (12h after learning) recall for rehearsed versus non-rehearsed items. [Срок оценки: Day 2 + 48 hours]

Критерии участия

Критерии включения

  • Patient with epilepsy (any type of epilepsy)
  • Hospitalized for video-EEG recording lasting at least 4 days
  • Aged 18-65 years

Критерии исключения

  • Major cognitive impairment other than memory deficit
  • Refusal to participate
  • Pregnant women, women in labor or nursing mothers
  • Persons deprived of their liberty by judicial or administrative decision
  • Persons under psychiatric care
  • Persons admitted to a health or social institution for purposes other than research
  • Adults under legal protection (guardianship, curatorship)

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
  • Service de neurologie fonctionnelle et d'épileptologie, Hôpital neurologique Pierre Werthe — Bron

Идентификаторы

NCT: NCT06967935 · 69HCL25_0188 · 2025-A00510-49

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗