TIPI²: Multimodal Study of the Human Brain Epilepsy Tissue
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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:
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electrophysiological analyses
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immunohistochemistry and genetic studies
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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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: epileptic patients All patients will be enrolled in the same arm. Patients can be enrolled during the pre-surgical evaluation (group 1) or in the days preceding the surgery (group 2). |
Other: 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.
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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18 yo or above
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patients with a focal drug-resistant epilepsy
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patients hospitalized for a pre-surgical evaluation or for an epilepsy surgery
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consent obtained from the patient, or legally authorized representative
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affiliated to a social security system
Exclusion Criteria:
- None
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Department of Neurology, Epilepsy Unit, Pitié-Salpêtrière Hospital | Paris | France | 75013 |
Sponsors and Collaborators
- Assistance Publique - Hôpitaux de Paris
- ICM Co. Ltd.
- Institut National de la Santé Et de la Recherche Médicale, France
Investigators
- Principal Investigator: Vincent M. Navarro, MD, PHD, APHP
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- APHP230479