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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-A00157-42 | Other Identifier | RCB number |
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recruitment shortage
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| The 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). |
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| Measure | Description | Time Frame |
|---|---|---|
| Serum S100B level | ng/ml | Day 0 (T0+6 hours) |
| Serum S100B level | ng/ml | Day 0 (T0+12 hours) |
| Seizure recurrence within 1 year | yes/no | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Serum S100B level | ng/ml | Between days 14 and 28 |
| Serum S100B level | ng/ml | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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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).
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| Name | Affiliation | Role |
|---|---|---|
| Nicola Marchi, MD | Institut de Génomique Fonctionnelle, CNRS, Montpellier | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| APHM - Hôpital Nord | Marseille | 13915 | France | |||
| CHRU de Nîmes - Hôpital Universitaire Carémeau |
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| ID | Term |
|---|---|
| D004827 | Epilepsy |
| D012640 | Seizures |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
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Processing of blood samples: 4-5ml of the blood sample will be centrifuged to isolate serum; S100B, IL-1b, IL-6, NSE levels will be investigated at D0 (T0+6h, T0+12h where T0 is seizure time) D14-D28. The remaining blood and cells will be stored at -80°C for future analyses.
| Serum S100B level | ng/ml | 12 months |
| Serum S100B level | ng/ml | at time of 2nd seizure (expected max of 12 months) |
| Serum IL-1b level | pg/mL | Day 0 (T0+6 hours) |
| Serum IL-1b level | pg/mL | Day 0 (T0+12 hours) |
| Serum IL-1b level | pg/mL | Between days 14 and 28 |
| Serum IL-6 level | pg/mL | Day 0 (T0+6 hours) |
| Serum IL-6 level | pg/mL | Day 0 (T0+12 hours) |
| Serum IL-6 level | pg/mL | Between days 14 and 28 |
| Serum NSE level | µg/dL | Day 0 (T0+6 hours) |
| Serum NSE level | µg/dL | Day 0 (T0+12 hours) |
| Serum NSE level | µg/dL | Between days 14 and 28 |
| Electro encephalogram profile | Day 0 |
| Electro encephalogram profile | Between days 14 and 28 |
| Nîmes |
| 30029 |
| France |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |