Prospective Evaluation of Probabilistic Predictions of Epileptic Seizure Risk Using the EPIDAY Tool
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Evaluation of the performance of daily probabilistic prediction of epileptic seizure risk using the EPIDAY mobile application, in patients with focal epilepsy, under real-life conditions.
研究概览
简要总结
Studies suggest the existence of a pre-critical state preceding the onset of an epileptic seizure. Identifying these states from self-reported prodromal symptoms, combined with machine learning algorithms, could help anticipate seizures.
详细描述
Around 65 million people worldwide, or 1% of the global population, suffer from epilepsy. It is the 3rd most common neurological pathology. Epilepsy is a chronic condition liable to generate spontaneous and repeated epileptic seizures, and it is estimated that around a third of patients are drug-resistant and will continue to have seizures despite appropriate anti-epileptic treatment. The onset of a seizure is a paroxysmal and unpredictable phenomenon - "a thunderclap in a serene sky" - which accounts for the handicap and social repercussions for patients.
The concept of a limited two-state model in epilepsy - i.e. intercritical/critical - has been challenged in recent decades. Ictogenesis could include a transitional state characterized by changes in cortical excitability that would pave the way for the onset of an epileptic seizure. This so-called pre-critical state is the scientific basis for seizure prediction models. If this state can be detected long enough before the onset of a seizure to detect a change in the brain's state, a seizure-stopping intervention (medication, biofeedback techniques, stimulation techniques, etc.), or at least safety measures, can be proposed.
While a deterministic approach has long been applied to predictive models - to predict the occurrence of the next crisis - a new strategy has more recently developed. Today's strategies are more realistic and adapted to non-linear dynamic systems. Indeed, probabilistic approaches from the meteorological sciences are increasingly being applied to crisis prediction models. The aim of crisis forecasting is to estimate the probability of a future crisis at any given time, whereas classical prediction algorithms aim to accurately predict the occurrence of a future crisis. In this way, we can identify a "pro"-critical state, i.e. a state at high risk of epileptic seizure.
Several studies have suggested the existence of a pre-critical period. However, identifying specific pre-critical biomarkers remains a major challenge. While information derived from EEG signals has long been favored, analysis of clinical symptoms has emerged more recently. Pre-critical clinical symptoms, otherwise known as "prodromes" or "prodromal symptoms", may precede the seizure by several hours. Some studies have also highlighted the value of integrating self-prediction - the patient's subjective assessment of the risk of an upcoming crisis - without anticipation models.
Previous work by the investigators has developed a classification algorithm capable of identifying a pre-critical state from the daily assessment of several prodromal symptoms. These results were obtained in a hospital setting, with good classification performance. This work was the subject of a European patent application (No. 20306548.7) on December 11, 2020 and an international patent application (No. PCT/EP2021/085146) on December 10, 2021: "A computer-implemented model for predicting occurrence of a seizure and training method thereof".
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 65
- •Focal epilepsy diagnosed for at least 18 months
- •Brain imaging as part of the etiological work-up for epilepsy showing no progressive cause
- •EEG compatible with the diagnosis of epilepsy within the last 10 years
- •At least 2 non-contiguous days of epileptic seizures per month, according to the patient
- •Ability of the patient to understand and use a mobile application on the personal smartphone
- •Free, informed and signed consent
- •Affiliation with a social security scheme (excluding AME)
排除标准
- •Suspicion or diagnosis of other types of associated malaise: functional dissociative seizures, syncope or other malaise of non-neurological origin
- •Assessment of seizure frequency deemed unreliable by the investigator (eg. due to cognitive impairment)
- •Inability to describe seizures accurately
- •Presence of more than 15 days with seizures per month
- •Participation in other interventional research or exclusion period not expired
- •Pregnant or breastfeeding woman
- •Patient under guardianship, curatorship, deprived of liberty
研究组 & 干预措施
EPIDAY application
Daily self-assessment via the Epiday application and collection of a seizure diary.
干预措施: Seizure diary (Behavioral)
EPIDAY application
Daily self-assessment via the Epiday application and collection of a seizure diary.
干预措施: Questionnaries (Behavioral)
结局指标
主要结局
Evaluation of the performance of daily probabilistic prediction of epileptic seizure risk using the EPIDAY mobile application, in patients with focal epilepsy, under real-life conditions.
时间窗: 28 months
number of patients with a Brier score \< 0.3 and a Brier Skill Score \> 0
次要结局
未报告次要终点
