Department of Neurology, Epilepsy Unit, Pitié-Salpêtrière Hospital
Paris, 75013, France
Location status: Recruiting
Recruiting
NCT Number: NCT06022055
Multimodal Study of the Human Brain Epilepsy Tissue
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.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Blood and Tissue Collection
OtherBlood 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.
Primary outcomes
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Identification of new pathophysiological mechanisms leading to focal drug-resistant epilepsy : analysis by immuno-histological methods
Time frame: At the day of surgery; analyses are based on the post-operative tissues
The investigator will identify inflammatory cells (astrocytes, microglia, lymphocytes and neutrophil polynuclear cells) in the post-operative brain tissue, and will calculate if there is an increase of a part of these cells in the area, defined as the seizure onset zone, as compared to the non-epileptic areas.
-
Identification of new pathophysiological mechanisms leading to focal drug-resistant epilepsy : analysis by electrophysiological methods
Time frame: At the day of surgery; analyses are based on the post-operative tissues
The investigator will record local field potentials and neuronal firing rate from post-operative tissues, and we will research an increase of the rate of interictal epileptiform discharges and of the frequency of the neuronal firing in the seizure-onset zone, as compared to those in non-epileptic areas.
-
Identification of new pathophysiological mechanisms leading to focal drug-resistant epilepsy : analysis by RNA sequencing methods
Time frame: At the day of surgery; analyses are based on the post-operative tissues
The investigator will measure the expression of mRNA in cells of different parts of the post-operative brain tissue, and we will research specific expression of mRNA in the Seizure onset zone, as compared to that in other non-epileptic areas.
Secondary outcomes
-
Identification of new pathophysiological mechanisms associated with the occurrence of a seizure : analysis of biomarkers by ELISA methods
Time frame: from inclusion day to 36 months after the surgery
The investigator will measure several proteins by Elisa, and we will define if there is a specific increase of some proteins in the sample after a seizure, as compared to the level of these proteins far from a seizure.
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Identification of new pathophysiological mechanisms associated with an active epilepsy : analysis of biomarkers by ELISA methods
Time frame: from inclusion day to 36 months after the surgery
The investigator will measure the different blood cells by flow cytometry, and we will define if there is a specific increase of some cell populations in the sample from epileptic patients, as compared to the level of these cell populations in non-epileptic patients.
-
Identification of new pathophysiological mechanisms associated with an active epilepsy : analysis of blood cell subtypes by flow cytometry
Time frame: from inclusion day to 36 months after the surgery
The investigator will measure the different blood cells by flow cytometry, and we will define if there is a specific increase of some cell populations in the sample from epileptic patients, as compared to the level of these cell populations in non-epileptic patients.
-
Identification of new pathophysiological mechanisms associated with an active epilepsy : analysis of inflammation biomarkers by digital ultra-sensitive quantitation of proteins methods
Time frame: from inclusion day to 36 months after the surgery
The investigator will measure several inflammatory proteins including cytokines, and we will define if there is a specific increase of some proteins in the sample from epileptic patients, as compared to the level of these proteins in non-epileptic patients.
Study contacts
Contact information is provided by the study sponsor or research team.
Aurélie Ms Hanin, PharmD, PhD
CONTACT
01 57 27 40 56 ext. +33
Vincent M. Navarro, MD, PHD
CONTACT
01 42 16 19 40 ext. +33
Sponsors and collaborators
Lead sponsor
Assistance Publique - Hôpitaux de Paris
Other
Collaborators
- ICM Co. Ltd.
- Institut National de la Santé Et de la Recherche Médicale, France
Registry information
Acronym: TIPI²
Important dates
- Study start
- 2024
- Primary completion
- 2037
- Study completion
- 2037
- First posted
- Sep 1, 2023
- Registry last updated
- Jul 16, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.