Is Protein S100B a Predictor of First-to-chronic Seizure Conversion in Adults? (SeizS100B)

Is Protein S100B a Predictor of First-to-chronic Seizure Conversion in Adults? A Prognostic Cohort Study

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.

Study Overview

• Status: Completed
• Conditions: Epilepsy; Seizures, Epileptic

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).

• Study Type: Observational
• Enrollment (Actual): 37

Contacts and Locations

Study Locations

• France
  • Marseille Cedex 20, France, 13915
    • APHM - Hôpital Nord
  • Nîmes Cedex 09, France, 30029
    • CHRU de Nîmes - Hôpital Universitaire Carémeau

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 59 years (Adult)
• Accepts Healthy Volunteers: No

• 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).

Description

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).

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum S100B level	ng/ml	Between days 14 and 28
Serum S100B level	ng/ml	6 months
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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes
• Investigators: Study Director: Nicola Marchi, MD, Institut de Génomique Fonctionnelle, CNRS, Montpellier

Study record dates

Study Major Dates

• Study Start (Actual): October 11, 2016
• Primary Completion (Actual): July 30, 2020
• Study Completion (Actual): July 30, 2020

Study Registration Dates

• First Submitted: April 20, 2015
• First Submitted That Met QC Criteria: April 21, 2015
• First Posted (Estimated): April 22, 2015

Study Record Updates

• Last Update Posted (Estimated): December 6, 2023
• Last Update Submitted That Met QC Criteria: December 5, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Seizures
• Other Study ID Numbers: LOCAL/2014/ET-02; 2015-A00157-42 (Other Identifier: RCB number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No