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Multimodal Study of the Human Brain Epilepsy Tissue (TIPI²)

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ClinicalTrials.gov Identifier: NCT06022055
Recruitment Status : Recruiting
First Posted : September 1, 2023
Last Update Posted : March 6, 2024
Sponsor:
Collaborators:
ICM Co. Ltd.
Institut National de la Santé Et de la Recherche Médicale, France
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Study Description
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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
Focal Drug-resistant Epilepsy Other: Blood and tissue collection Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Multimodal Study of the Human Brain Epilepsy Tissue
Actual Study Start Date : February 29, 2024
Estimated Primary Completion Date : February 28, 2030
Estimated Study Completion Date : February 28, 2037

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy

Arms and Interventions
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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
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Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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 Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06022055


Contacts
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Contact: Vincent M. Navarro, MD, PHD 01 42 16 19 40 ext +33 Vincent.navarro@aphp.fr
Contact: Aurélie Ms Hanin, PharmD, PhD 01 57 27 40 56 ext +33 Aurelie.hanin@icm-institute.org

Locations
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France
Department of Neurology, Epilepsy Unit, Pitié-Salpêtrière Hospital Recruiting
Paris, France, 75013
Contact: Vincent M. Navarro, MD, PHD    01 42 16 19 40 ext +33    Vincent.navarro@aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
ICM Co. Ltd.
Institut National de la Santé Et de la Recherche Médicale, France
Investigators
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Principal Investigator: Vincent M. Navarro, MD, PHD APHP
More Information
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT06022055    
Other Study ID Numbers: APHP230479
First Posted: September 1, 2023    Key Record Dates
Last Update Posted: March 6, 2024
Last Verified: March 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Data are available upon reasonable request

The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l'informatique et des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients.

Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Time Frame: Beginning 3 months and ending 3 years following article publication. Requests out of these time frame can also be submitted to the sponsor.
Access Criteria: Researchers who provide a methodologically sound proposal.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Focal drug-resistant epilepsy
Surgery
Biorepository
Biomarkers
Additional relevant MeSH terms:
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Epilepsy
Drug Resistant Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases