Ireland
--:--IST
Recruiting Not applicable

Multimodal Study of the Human Brain Epilepsy Tissue

NCT06022055 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2024-02-29
Last updated
2026-07-16

Condition(s) studied

Focal Drug-resistant Epilepsy

Investigational drug(s) / intervention(s)

Blood and tissue collection

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.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
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

Primary outcome measure(s)

  • 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.

Trial sites (1)

FacilityCityRegionStatus
Department of Neurology, Epilepsy Unit, Pitié-Salpêtrière Hospital Paris France Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06022055 on ClinicalTrials.gov ↗ ← All trials in France