Study of Pathophysiology of Status Epilepticus and Dysimmune Encephalitis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age2+
SponsorAssistance Publique - Hôpitaux de Paris
About this trial
COLETTE is an interventional study for which blood, cerebrospinal fluid and post-mortem tissues are collected in patients with status epilepticus or epilepsy associated to dysimmune encephalitis as well as in control patients, to better understand the pathophysiology of these severe epileptic disorders.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients aged 2 years or above, with status epilepticus.
Affiliation to a French social security system excluding "Aide Médicale" Etat (AME).
Patients or relatives have been informed and given free informed and written consent to participate
Patients under legal protection (guardianship, curatorship) or not
Disqualifiers
Women with known or clinically detected pregnancy.
Patient deprived of liberty
Patients with known neurodegenerative disease.
Women with known or clinically detected pregnancy.
Trial design
Design model
Parallel
Treatments tested in this trial
Blood sampling, cerebrospinal fluid , post-mortem cerebral tissues (NA for the Group 3)
Other interventionCollection of biological samples and clinical/paraclinical data
Blood sampling, cerebrospinal fluid, stool sampling post-mortem cerebral tissues (NA for the Group 3)
Other interventionCollection of biological samples and clinical/paraclinical data
Treatment groups
400 Participants
are divided into 3 treatment groupsGroup A: Group 1 : Status epilepticusOther 1 intervention
Group B: Group 2 : Dysimmune encephalitisOther 1 intervention
Group C: Group 3 : Control patientsOther 1 intervention
Trial outcomes
Primary outcomes
1
Identification of (i) antibodies in the plasma and in the cerebrospinal fluid of patients with dysimmune encephalitis and (ii) biomarkers for neuronal death in the plasma and in the cerebrospinal fluid of patients with status epilepticus
Looking for antibodies with cell-based binding assay or monospecific recombinant assay. Identification of biomarkers for neuronal death with electrochemiluminometric sandwich immunoassays (Kryptor and ModularE170, Roche Diagnostic)
Time frame
9 months and 24 monthsSecondary outcomes
1
Identification of new dysimmune abnormalities
Lymphocyte phenotyping, cytokines quantification
Time frame
9 months and 24 months2
Identification of specific EEG patterns associated to dysimmune encephalitis and/or status epilepticus
EEG signals will be reviewed and classifiyed according to a EEG-based seizure build-up score in status epilepticus (EaSiBUSSEs)
Time frame
9 months and 24 months3
Identification of new genetic pathways associated to dysimmune encephalitis and status
Genetic biomarkers
Time frame
9 months and 24 months4
Identification of new metabolic pathway that may participate in the excitotoxicity observed in status epilepticus or dysimmune encephalitis
Looking for diagnostic and prognosis biomarkers. Characterization of the brain cholesterol homeostasis with UPLC-MS/MS method and enzymatic assays. Evaluation of new biomarkers (proteins, lipids, genes).
Time frame
9 months and 24 monthsSponsors and contacts
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Source ClinicalTrials.gov