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Идёт набор NCT07542977

Individual Neurophysiological Sensory Profiles in People With and Without Neurodevelopmental Disorders

— Наблюдательное Neurodevelopmental 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
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Neurodevelopmental Disorders. Базовые параметры: 6 лет — 45 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

The goal of this observational study is to evaluate intra-individual neurophysiological variability in children and adults with and without NeuroDevelopmental Disorders (NDD), for several sensory modalities and types of stimulation. The main hypotheses are: * NDD participants and children exhibit higher intra-individual variability than other participants * intra-individual neurophysiological variability is correlated to behavioral, psychological and learning profiles Participants in this study will: * be recorded for EEG and other neurophysiological parameters while exposed to sensory stimulations, to quantify sensory neurophysiological variability * perform behavioral tests and fill out questionnaires, to establish the behavioral and psychological profile * train for perceptual learning, to measure learning abilities These evaluations will be split in 3 visits spread on a maximum of 3 months, and training for learning will be done at home in between 2 visits.

Первичные конечные точки

  • Amplitude of central neurophysiological responses to sensory stimulations [Срок оценки: Through study completion, an average of 2 months per participant]
  • Latency of central neurophysiological responses to sensory stimulations [Срок оценки: Through study completion, an average of 2 months per participant]
  • Variability of central neurophysiological responses to sensory stimulations [Срок оценки: Through study completion, an average of 2 months per participant]
Вторичные конечные точки (12)
  • Visual perceptual learning performance [Срок оценки: Through study completion, an average of 2 months per participant]
  • Auditory perceptual learning performance [Срок оценки: Through study completion, an average of 2 months per participant]
  • Behavioral sensory profile [Срок оценки: Through study completion, an average of 2 months per participant]
  • Sensory profile questionnaire [Срок оценки: Through study completion, an average of 2 months per participant]
  • Cognitive psychological profile [Срок оценки: Through study completion, an average of 2 months per participant]
  • Executive functions questionnaire [Срок оценки: Through study completion, an average of 2 months per participant]
  • Attentional functions questionnaire [Срок оценки: Through study completion, an average of 2 months per participant]
  • Socio-emotional questionnaire [Срок оценки: Through study completion, an average of 2 months per participant]
  • Linguistic profile [Срок оценки: Through study completion, an average of 2 months per participant]
  • Heart beat response to sensory stimulations [Срок оценки: Through study completion, an average of 2 months per participant]
  • Electrodermal activity response to sensory stimulations [Срок оценки: Through study completion, an average of 2 months per participant]
  • Pupillary response to sensory stimulations [Срок оценки: Through study completion, an average of 2 months per participant]

Критерии участия

Критерии включения

  • Social security affiliation
  • Free and written informed consent from the participants (Neurotypical Adults, NDD Adults without judicial protective measures), or their tutor or legal representant(s) (other participants)
  • Age between 6 and 12 years included (Children) or between 18 and 45 years included (Adults)
  • For NDD participants: NDD diagnosis by a qualified medical professional, according to DSM-4, DSM-5, ICD-10 or ICD-11 criteria

Non-inclusion Criteria:

  • Psychotropic medication perturbing EEG recording
  • Drugs pertubing peripheral neurophysiological measures
  • Non-corrected visual or auditory troubles
  • Known neurological or psychiatric conditions (at the exclusion of NDD for NDD participants)
  • Epilepsy
  • Inclusion in another ongoing medical protocol
  • For Neurotypical participants: NDD diagnosis
  • For NDD participants: anticipated psychological or physical risk at participating, at the investigator's discretion

Критерии исключения

  • Participants with no data to evaluate Outcome 1

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

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Случай-контроль

Центры проведения

Франция · 1 центр
  • WARDAK — Tours

Идентификаторы

NCT: NCT07542977 · DR240270

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗