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

Epilepsy Clinical Trial

— SeizS100B  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02424123
• Other study ID #: LOCAL/2014/ET-02
• Secondary ID: 2015-A00157-42
• Status: Completed
• Start date: October 11, 2016
• Est. completion date: July 30, 2020

Study information

• Verified date: December 2023
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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: 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: July 30, 2020
• Est. primary completion date: July 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 59 Years

Eligibility

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).

Related Conditions & MeSH terms

• Epilepsy
• Seizures
• Seizures, Epileptic

Locations

Country	Name	City	State
France	APHM - Hôpital Nord	Marseille Cedex 20
France	CHRU de Nîmes - Hôpital Universitaire Carémeau	Nîmes Cedex 09

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum S100B level	ng/ml	Day 0 (T0+6 hours)
Primary	Serum S100B level	ng/ml	Day 0 (T0+12 hours)
Primary	Seizure recurrence within 1 year	yes/no	12 months
Secondary	Serum S100B level	ng/ml	Between days 14 and 28
Secondary	Serum S100B level	ng/ml	6 months
Secondary	Serum S100B level	ng/ml	12 months
Secondary	Serum S100B level	ng/ml	at time of 2nd seizure (expected max of 12 months)
Secondary	Serum IL-1b level	pg/mL	Day 0 (T0+6 hours)
Secondary	Serum IL-1b level	pg/mL	Day 0 (T0+12 hours)
Secondary	Serum IL-1b level	pg/mL	Between days 14 and 28
Secondary	Serum IL-6 level	pg/mL	Day 0 (T0+6 hours)
Secondary	Serum IL-6 level	pg/mL	Day 0 (T0+12 hours)
Secondary	Serum IL-6 level	pg/mL	Between days 14 and 28
Secondary	Serum NSE level	µg/dL	Day 0 (T0+6 hours)
Secondary	Serum NSE level	µg/dL	Day 0 (T0+12 hours)
Secondary	Serum NSE level	µg/dL	Between days 14 and 28
Secondary	Electro encephalogram profile		Day 0
Secondary	Electro encephalogram profile		Between days 14 and 28