A Prospective, Multicenter, Exploratory Study for Epileptic Seizures Detection Through Multimodal Analysis of Cardiorespiratory and Actimetry Parameters
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 12
- 主要终点
- Number of false positive seizures.
研究概览
简要总结
Epilepsy is a disabling neurological disease that affects tens of millions of people worldwide. Despite therapeutic advances, about a third of these patients suffer from treatment-resistant forms of epilepsy and still experience regular seizures.All seizures can last and lead to status epilepticus, which is a major neurological emergency. Epilepsy can also be accompanied with cognitive or psychiatric comorbidities.
Reliable seizures count is an essential indicator for estimating the care quality and for optimizing treatment. Several studies have highlighted the difficulty for patients to keep a reliable seizure diary due for example to memory loss or perception alterations during crisis. Whatever the reasons, it has been observed that at least 50% of seizures are on average missed by patients.
Seizure detection has been widely developed in recent decades and are generally based on physiological signs monitoring associated with biomarkers search and coupled with detection algorithms. Multimodal approaches, i.e. combining several sensors at the same time, are considered the most promising.
Mobile or wearable non invasive devices, allowing an objective seizures documentation in daily life activities, appear to be of major interest for patients and care givers, in detecting and anticipating seizures occurence.
This single-arm exploratory, multicenter study aims at assessing whether the use of such a non-invasive, wearable device can be useful in a real life setting in detecting seizures occurence through multimodal analysis of various parameters (heart rate, respiratory and accelerometry).
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
- 7 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 7 years old or more
- •Patients with drug-resistant focal epilepsy
- •Patients with high frequency seizures according to investigator's judgement
- •Patients that can be followed 4 weeks after inclusion
- •Informed consent form signed.
排除标准
- •Generalised tonic-clonic seizures
- •Frequent psychogenic non-epileptic seizures
- •Pregnant or breastfeeding patients
- •Patients displaying sensor contraindications
结局指标
主要结局
Number of false positive seizures.
时间窗: From baseline up to 4 weeks.
The number of false positive seizures will be measured, ie. seizures detected through the sensor but not reported in the seizures diary completed in real time by care giver.
Number of true positive seizures.
时间窗: From baseline up to 4 weeks.
The number of true positive seizures will be measured, ie. seizures detected through the sensor and reported in a seizures diary completed in real time by care giver.
Number of false negative seizures.
时间窗: From baseline up to 4 weeks.
The number of false negative seizures will be measured, ie. seizures not detected through the sensor but reported in the seizures diary completed in real time by care giver.
次要结局
- Sensor tolerability from care givers' perspective.(At 4 weeks after baseline.)
- Respiration rate impact on seizures detection.(From baseline up to 4 weeks.)
- Changes in Number of true positive, true negative and false negative seizures throughout the study duration.(From baseline up to 4 weeks.)
- Electrocardiogram signal quality in real life setting.(From baseline up to 4 weeks.)
- Activity impact on seizures detection.(From baseline up to 4 weeks.)
- Body orientation impact on seizures detection.(From baseline up to 4 weeks.)
- Changes in number of true positive, true negative and false negative seizures depending on patients' characteristics.(From baseline up to 4 weeks.)
- Sensor tolerability from patients' perspective.(At 4 weeks after baseline.)
- ECG data impact (ECG characteristics) on seizures detection.(From baseline up to 4 weeks.)
- Heart rate impact on seizures detection.(From baseline up to 4 weeks.)