Is Protein S100B a Predictor of First-to-chronic Seizure Conversion in Adults? A Prognostic Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 37
- 试验地点
- 2
- 主要终点
- Serum S100B level
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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).
研究组 & 干预措施
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).
结局指标
主要结局
Serum S100B level
时间窗: Day 0 (T0+12 hours)
ng/ml
Serum S100B level
时间窗: Day 0 (T0+6 hours)
ng/ml
Seizure recurrence within 1 year
时间窗: 12 months
yes/no
次要结局
- Serum IL-1b level(Day 0 (T0+12 hours))
- Serum IL-6 level(Day 0 (T0+6 hours))
- Serum IL-6 level(Day 0 (T0+12 hours))
- Serum NSE level(Day 0 (T0+6 hours))
- Serum NSE level(Day 0 (T0+12 hours))
- Electro encephalogram profile(Day 0)
- Serum IL-1b level(Day 0 (T0+6 hours))
- Serum S100B level(6 months)
- Serum S100B level(Between days 14 and 28)
- Serum S100B level(12 months)
- Serum S100B level(at time of 2nd seizure (expected max of 12 months))
- Electro encephalogram profile(Between days 14 and 28)
- Serum IL-6 level(Between days 14 and 28)
- Serum IL-1b level(Between days 14 and 28)
- Serum NSE level(Between days 14 and 28)