Is Protein S100B a Predictor of First-to-chronic Seizure Conversion in Adults?

  • STATUS
    Recruiting
  • End date
    Dec 16, 2022
  • participants needed
    75
  • sponsor
    Centre Hospitalier Universitaire de Nīmes
Updated on 16 January 2022
seizure

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.

Description

The secondary objectives of this study are to investigate the:

  1. 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.
  2. Correlation of S100B with IL-1b, IL-6, NSE serum levels at the same time points.
  3. Association of serology data with: a) EEG profile (normal/abnormal); b) recurrence of seizures (Y/N).
  4. Comparison of S100B serum levels in lesional vs non-lesional patients. F) Establishment of a bio-bank (serum and cells).

Details
Condition Epilepsy, Seizures, Epileptic
Clinical Study IdentifierNCT02424123
SponsorCentre Hospitalier Universitaire de Nīmes
Last Modified on16 January 2022

Eligibility

Yes No Not Sure

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)
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