Epilepsy, Seizures, Epileptic
Conditions
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).
Interventions
None listed
Sponsors
Centre Hospitalier Universitaire de Nīmes
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 59 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serum S100B level | Day 0 (T0+6 hours) | ng/ml |
| Seizure recurrence within 1 year | 12 months | yes/no |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serum S100B level | Between days 14 and 28 | ng/ml |
| Serum IL-1b level | Day 0 (T0+6 hours) | pg/mL |
| Serum IL-6 level | Day 0 (T0+6 hours) | pg/mL |
| Serum NSE level | Day 0 (T0+6 hours) | µg/dL |
| Electro encephalogram profile | Day 0 | — |
Countries
France
Contacts
STUDY_DIRECTORNicola Marchi, MD
Institut de Génomique Fonctionnelle, CNRS, Montpellier
Outcome results
None listed