Home Ultra-longterm EEG Monitoring for Rare Epilepsies and Developmental and Epileptic Encephalopathies. an Open Label Nonpharmacological Interventional Prospective Study by Means of Minimally Invasive Wearable EEG Device
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 8
- 主要终点
- Assessment of the reportability
研究概览
简要总结
With this study the Investigator expects to develop a precise patient-centered model of care by means of home ultra-long-term EEG monitoring with a minimally invasive wearable EEG device (sqEEG).
The following aims will be pursued:
- to assess the sensitivity, reliability, and safety of sqEEG to record seizures over prolonged periods;
- to verify sensitivity and reliability of automated seizure detection algorithms and to assess circadian and ultradian seizure/interictal epileptic discharges; distribution for the development of personalized seizure action plan;
- to evaluate whether data collected with sqEEG can improve the clinical management of the patients and treatment outcomes.
The investigator expects to use this wearable at-home EEG device to obtain an objective quantification of electrographic and electro-clinical seizures over a twelve-week period up to twenty-four weeks at home. The precise quantification of seizures is essential for a tailored treatment approach and to effectively monitor the response to treatment adjustments.
The potential innovation of this approach relies on the possibility of managing the patient at home, reducing the side effects related to hospitalization and objectively quantifying the disease burden in the real-life setting with the aim of improve globally the patients' quality of life.
详细描述
Initial screening of the subjects.
Subjects with DEE or rare epilepsies with uncontrolled seizures and previously investigated in outpatients epilepsy clinics and in the Epilepsy Monitoring Unit (EMU) will be evaluated by review of the medical records.
The aim is to select subjects in whom assessment of seizure frequency is extremely relevant for their clinical management, including adjustment of medicines and need of support measures in their daily life. The indication to recruit also patients with epilepsy and intellectual disabilities is supported by the evidence that in these patients, either when living at home or in institutions, it is particularly difficult to have an objective assessment of their seizure frequency and of the response to treatment or to treatment adjustments. The use of sqEEG in this group of patients is therefore expected to provide extremely valuable information on the disease severity (i.e. seizure frequency) and the epilepsy modification following treatment changes.
The subjects will be selected regardless of a diagnosis of focal or generalized epilepsy, and regardless previous surgical treatments.
Recruitment and consent. The written consent form will be presented and discussed with the subject/legal guardians; all questions related to the informed consent will be answered. In all cases patients will receive detailed information regarding the procedure and purposes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 12 years old, with or without intellectual disabilities;
- •Diagnosis of drug resistant seizures, DEE or rare epilepsies ;
- •One or more seizure types as established by previous epilepsy history thus allowing to define seizure type and scalp topography of the ictal discharge;
- •Availability for the duration of the study (3 months);
排除标准
- •Subjects with psychiatric disorders including schizophrenia, bipolar affective disorder, emotionally unstable personality disorder, schizoaffective disorder;
- •Subject has skeletal deformities or damage at the proposed implantation site to an extent that impedes correct electrode placement;
- •Subject has an infection at implant site;
- •Subjects at high risk of surgical complications, such as active systemic infection and hemorrhagic disease;
- •Subject has or is exposed to a medical device that delivers electrical energy into the area around the implant (cochlear implant(s));
- •Subject has a profession or hobby that includes activity imposing an unacceptable risk for trauma to the device or implant site, e.g. martial arts or boxing;
- •Subject has a contraindication to the use of local anesthetic drugs used during implantation- and removal of the device;
- •Subject is unable or does not have the necessary assistance to properly operate the device system.
- •Pregnancy
结局指标
主要结局
Assessment of the reportability
时间窗: 12-24 weeks from device activation
The results (i.e., number of seizures, date and time) will be matched with the subject's seizure diary to look for concordance.
次要结局
- Assessment of Device-Related Adverse Events:(12-24 weeks from device activation)
- Evaluation of the algorithm for automatic seizure detection (ASD)(12-24 weeks from device activation)
- Assessment of potential clinical impact(12 to 24 weeks from device activation)
研究者
Stefano Meletti
MD, PhD
Azienda Ospedaliero-Universitaria di Modena