Clinical trial NCT06022055: Multimodal Study of the Human Brain Epilepsy Tissue
Official title: Multimodal Study of the Human Brain Epilepsy Tissue
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Focal Drug-resistant Epilepsy
Keywords: Focal drug-resistant epilepsy
Surgery
Biorepository
Biomarkers
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: ICM Co. Ltd.
name: Institut National de la Santé Et de la Recherche Médicale, France
First posted: 2023-09-01
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* None

Primary outcomes:
measure: Identification of new pathophysiological mechanisms leading to focal drug-resistant epilepsy : analysis by immuno-histological methods
timeFrame: At the day of surgery; analyses are based on the post-operative tissues
measure: Identification of new pathophysiological mechanisms leading to focal drug-resistant epilepsy : analysis by electrophysiological methods
timeFrame: At the day of surgery; analyses are based on the post-operative tissues
measure: Identification of new pathophysiological mechanisms leading to focal drug-resistant epilepsy : analysis by RNA sequencing methods
timeFrame: At the day of surgery; analyses are based on the post-operative tissues
Secondary outcomes:
measure: Identification of new pathophysiological mechanisms associated with the occurrence of a seizure : analysis of biomarkers by ELISA methods
timeFrame: from inclusion day to 36 months after the surgery
measure: Identification of new pathophysiological mechanisms associated with an active epilepsy : analysis of biomarkers by ELISA methods
timeFrame: from inclusion day to 36 months after the surgery
measure: Identification of new pathophysiological mechanisms associated with an active epilepsy : analysis of blood cell subtypes by flow cytometry
timeFrame: from inclusion day to 36 months after the surgery
measure: Identification of new pathophysiological mechanisms associated with an active epilepsy : analysis of inflammation biomarkers by digital ultra-sensitive quantitation of proteins methods
timeFrame: from inclusion day to 36 months after the surgery
Other outcomes:
Locations:
city: Paris
country: France
facility: Department of Neurology, Epilepsy Unit, Pitié-Salpêtrière Hospital
Study officials:
affiliation: APHP
name: Vincent M. Navarro, MD, PHD
role: PRINCIPAL_INVESTIGATOR
References: