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Идёт набор NCT05724719

Seizure Recurrence After Unprovoked First Seizure

— Наблюдательное Single Seizure Epilepsy

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: Single Seizure, Epilepsy. 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
Канада
Следующий шаг
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Официальное название

Multimodal Prediction of Seizure Recurrence After Unprovoked First Seizure to Guide Clinical Decision-making: a Multi-centre Study of Cognition, Mood and Brain Connectivity As Predictors

Обзор

One in 10 people have a seizure during their life. Usually no cause is identified. Seizures without an identified cause are called unprovoked first seizure (UFS). Most people with UFS do not have further seizures. Being able to predict the risk of more seizures as soon as possible would help doctors decide whether to suggest treatment after UFS. Studies show that seizures are associated with changes in brain structure and function that are difficult to detect with standard assessments but can be detected with advanced techniques. Changes in connections between brain regions are also linked to subtle problems in thinking and mood. The investigators will examine brain connections using detailed brain scans, thinking, and mood in people with UFS and develop an accurate method for calculating the risk of further seizures. 200 adult patients and 75 matched healthy controls from the Halifax and Kingston First Seizure Clinics will undergo cognitive screening assessment of major cognitive domains, MRI imaging including structural scans, resting-state functional MRI (rsfMRI) and diffusion-weighted imaging (DWI), and EEG. Seizure recurrence will be assessed prospectively and a multimodal machine learning model will be trained to predict seizure recurrence at 12 months.

Первичные конечные точки

  • Number of Participants with Seizure Recurrence after Unprovoked First Seizure [Срок оценки: 12 months]

Критерии участия

Критерии включения

  • This study will consider adult patients between the ages of 18-65 years seen in the First Seizure Clinics in Halifax and Kingston with unprovoked first seizure.
  • The investigators will also include a sample of age, sex, and education-matched healthy controls with the same exclusion criteria.

Критерии исключения

  • Individuals over the age of 65 will not be included to reduce the probability of including individuals with early dementia.
  • The investigators will also exclude individuals who, upon assessment during their first clinic appointment, are determined to have non-epileptic events, recurrent events or diagnosis of epilepsy (e.g. based on abnormal CT or EEG), provoked seizure (e.g. medication, substance misuse, metabolic), acute symptomatic seizures, those with an existing prescription for antiseizure drugs, significant CNS comorbidity that may affect cognition and brain networks (e.g. progressive neurological disorder, MS), previous neurosurgery, or contraindication to MRI.
  • Finally, although there is no known risk to a fetus from MRI scanning, as is standard in research studies involving MRI, pregnant participants will be excluded and those that suspect that they may be pregnant require a negative pregnancy test before scanning.

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

Канада · 2 центра
  • Dalhousie University and Nova Scotia Health Authority — Halifax
  • Queen's University and Kingston Health Sciences Centre — Kingston

Публикации

  • Beattie BC, Batista Garcia-Ramo K, Biggs K, Boisse Lomax L, Brien DC, Gallivan JP, Ikeda K, Schmidt M, Shukla G, Whatley B, Woodroffe S, Omisade A, Winston GP. Literature review and protocol for a prospective multicentre cohort study on multimodal prediction of seizure recurrence after unprovoked first seizure. BMJ Open. 2024 Apr 5;14(4):e086153. doi: 10.1136/bmjopen-2024-086153. PMID 38582538

Идентификаторы

NCT: NCT05724719 · DMED-2681-22 · PJT-183906

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗