Clinical trial NCT02424123: Is Protein S100B a Predictor of First-to-chronic Seizure Conversion in Adults?
Official title: Is Protein S100B a Predictor of First-to-chronic Seizure Conversion in Adults? A Prognostic Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Epilepsy
Seizures, Epileptic
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2015-04-22
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population is composed of patients between 18 and 60 years of age, of both sexes, recruited during consultations for a first epileptic seizure at the emergency department of Nîmes and Marseille Hospitals (CHRU).

Brief summary: Seizures represent an important clinical problem, accounting for at least 40% of adult onset epilepsy. Predicting seizure recurrence in subjects experiencing a first seizure is difficult due to the lack of prognostic biomarkers. Recent evidence has indicated that blood-brain barrier (BBB) dysfunction constitutes an etiological factor to seizures. In particular, it has been shown that modification of BBB permeability is associated with seizure activity. In addition, it was demonstrated that BBB permeability can be assessed by measuring serum level of the protein S100B. Based on these data and considerations the investigators will test whether the extent of BBB damage at time of first seizure is predictive for seizure recurrence.

The main objective of this study is to evaluate the association between the absolute (ng/ml) serum S100B levels (measured at time of the first seizure) and the experience, or not, of seizure recurrence within one year of follow-up.

Detailed description: The secondary objectives of this study are to investigate the:

A) Prognostic capacity of serum S100B levels to predict seizure recurrence. B) Association between the variation (%) of serum S100B levels between first seizure episode and scheduled follow-up (D14-D28) and seizure recurrence.

C) Correlation of S100B with IL-1b, IL-6, NSE serum levels at the same time points.

D) Association of serology data with: a) EEG profile (normal/abnormal); b) recurrence of seizures (Y/N).

E) Comparison of S100B serum levels in lesional vs non-lesional patients. F) Establishment of a bio-bank (serum and cells).

Eligibility criteria: Inclusion Criteria:

* The patient has been correctly informed.
* The patient must have given his informed and signed consent.
* The patient must be insured or beneficiary of a health insurance plan.
* The patient is at least (≥) 18 years old and less than (\<) 60 years old.
* The patient has experienced a first generalized, epileptic seizure (patients with partial onset and secondary generalization can also be included).
* The seizure has occurred less than 24 hours ago.

Exclusion Criteria:

* The patient is participating in another study that may interfere with the results or conclusions of this study.
* Within the past three months, the patient has participated in another study that may interfere with the results or conclusions of this study.
* The patient is in an exclusion period determined by a previous study.
* The patient is under judicial protection.
* The patient refuses to sign the consent.
* It is impossible to correctly inform the patient.
* The patient is pregnant or breast-feeding (MRI contraindicated).
* Patient has a previous abnormal brain imaging (MRI).
* Patient has abnormal biological tests for toxicology (alcohol, cocaine and cannabis tests), blood ionogram (hyponatremia \<130mM), liver enzymes (\>5N), inflammatory syndrome (elevated C-reactive protein).

Primary outcomes:
measure: Serum S100B level
timeFrame: Day 0 (T0+6 hours)
measure: Serum S100B level
timeFrame: Day 0 (T0+12 hours)
measure: Seizure recurrence within 1 year
timeFrame: 12 months
Secondary outcomes:
measure: Serum S100B level
timeFrame: Between days 14 and 28
measure: Serum S100B level
timeFrame: 6 months
measure: Serum S100B level
timeFrame: 12 months
measure: Serum S100B level
timeFrame: at time of 2nd seizure (expected max of 12 months)
measure: Serum IL-1b level
timeFrame: Day 0 (T0+6 hours)
measure: Serum IL-1b level
timeFrame: Day 0 (T0+12 hours)
measure: Serum IL-1b level
timeFrame: Between days 14 and 28
measure: Serum IL-6 level
timeFrame: Day 0 (T0+6 hours)
measure: Serum IL-6 level
timeFrame: Day 0 (T0+12 hours)
measure: Serum IL-6 level
timeFrame: Between days 14 and 28
measure: Serum NSE level
timeFrame: Day 0 (T0+6 hours)
measure: Serum NSE level
timeFrame: Day 0 (T0+12 hours)
measure: Serum NSE level
timeFrame: Between days 14 and 28
measure: Electro encephalogram profile
timeFrame: Day 0
measure: Electro encephalogram profile
timeFrame: Between days 14 and 28
Other outcomes:
Locations:
city: Marseille Cedex 20
country: France
facility: APHM - Hôpital Nord
city: Nîmes Cedex 09
country: France
facility: CHRU de Nîmes - Hôpital Universitaire Carémeau
Study officials:
affiliation: Institut de Génomique Fonctionnelle, CNRS, Montpellier
name: Nicola Marchi, MD
role: STUDY_DIRECTOR
References: