Focal Drug-resistant Epilepsy
Conditions
Keywords
Focal drug-resistant epilepsy, Surgery, Biorepository, Biomarkers
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.
Interventions
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.
Sponsors
Assistance Publique - Hôpitaux de Paris
ICM Co. Ltd.
Institut National de la Santé Et de la Recherche Médicale, France
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Identification of new pathophysiological mechanisms leading to focal drug-resistant epilepsy : analysis by immuno-histological methods | 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 | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Identification of new pathophysiological mechanisms associated with the occurrence of a seizure : analysis of biomarkers by ELISA methods | 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. |
| Identification of new pathophysiological mechanisms associated with an active epilepsy : analysis of biomarkers by ELISA methods | 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 | 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 | 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. |
Countries
France
Contacts
CONTACTVincent M. Navarro, MD, PHD
CONTACTAurélie Ms Hanin, PharmD, PhD
PRINCIPAL_INVESTIGATORVincent M. Navarro, MD, PHD
APHP
Outcome results
None listed