Multimodal Study of the Human Brain Epilepsy Tissue

Обзор

The TIPI2 study is a blood and tissue collection protocol to create an annotated biorepository to support research in drug-resistant epilepsy. The aim of the study will be to identify new pathophysiological pathways. For this purpose, the investigators will investigate with a multimodal approach blood and brain samples from patients undergoing a surgery for focal drug-resistant epilepsy. The adult patients will be enrolled either during the pre-surgical evaluation or right before the surgery.

Подробное описание

This study aims to investigate blood and brain samples from patients with drug-resistant epilepsy in order to identify new pathophysiological biomarkers.

The investigators will first conduct multimodal research, including:

* electrophysiological analyses * immunohistochemistry and genetic studies * biochemistry analyses

Samples will be stored at -80°C for future research.

Patients will undergo a follow-up evaluation within the 36 months following the surgery. New clinical data and biological samples will be collected then.

Вмешательства

• Другое Blood and tissue collection
  Blood will be collected for group 1 during (i) the enrolment visit, (ii) in the 24 hours following a seizure, (iii)before the surgery and (iv) in the 36 months following the surgery. The left-over tissue, not useful for diagnostic purpose, will be kept for research. Blood will be collected for group 2 right before the surgery and in the 36 months following the surgery. The left-over tissue not useful for diagnostic purpose will be kept for research.

Первичные конечные точки

• Identification of new pathophysiological mechanisms leading to focal drug-resistant epilepsy : analysis by immuno-histological methods [Срок оценки: At the day of surgery; analyses are based on the post-operative tissues]
• Identification of new pathophysiological mechanisms leading to focal drug-resistant epilepsy : analysis by electrophysiological methods [Срок оценки: At the day of surgery; analyses are based on the post-operative tissues]
• Identification of new pathophysiological mechanisms leading to focal drug-resistant epilepsy : analysis by RNA sequencing methods [Срок оценки: At the day of surgery; analyses are based on the post-operative tissues]

Вторичные конечные точки (4)

• Identification of new pathophysiological mechanisms associated with the occurrence of a seizure : analysis of biomarkers by ELISA methods [Срок оценки: from inclusion day to 36 months after the surgery]
• Identification of new pathophysiological mechanisms associated with an active epilepsy : analysis of biomarkers by ELISA methods [Срок оценки: from inclusion day to 36 months after the surgery]
• Identification of new pathophysiological mechanisms associated with an active epilepsy : analysis of blood cell subtypes by flow cytometry [Срок оценки: from inclusion day to 36 months after the surgery]
• Identification of new pathophysiological mechanisms associated with an active epilepsy : analysis of inflammation biomarkers by digital ultra-sensitive quantitation of proteins methods [Срок оценки: from inclusion day to 36 months after the surgery]

Критерии участия

Критерии включения

• 18 yo or above
• patients with a focal drug-resistant epilepsy
• patients hospitalized for a pre-surgical evaluation or for an epilepsy surgery
• consent obtained from the patient, or legally authorized representative
• affiliated to a social security system

Критерии исключения

• None

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Фундаментальное исследование

Центры проведения

Франция · 1 центр

• Department of Neurology, Epilepsy Unit, Pitié-Salpêtrière Hospital — Paris

Идентификаторы

NCT: NCT06022055 · APHP230479

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗