Wearable Epileptic Seizure Prediction and Alert Glasses Based on Neuromorphic Computing
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 47
- 试验地点
- 1
- 主要终点
- Accurate Seizure Detection in Real-World Patient Settings
研究概览
简要总结
The NEXA study aims to evaluate a new wearable EEG device designed as smart glasses with dry electrodes positioned according to the 10-20 system. The device captures real-time brain signals to detect patterns that may predict seizures, helping people with epilepsy. This study will test the device's safety, performance, and usability before seeking regulatory approval, including FDA clearance. The NEXA device is investigational and not yet approved by the U.S. FDA. The study will involve human participants who will wear the device while data is collected and analyzed. Results will help improve the device and support future certification for medical use.
详细描述
The NEXA Study is a prospective observational clinical trial designed to evaluate the safety, comfort, and performance of the NEXA wearable EEG device in patients with epilepsy. NEXA uses an innovative dry electrode system (two dome-shaped electrodes at the front and two spiked electrodes above the ears) aligned with the 10-20 EEG placement system to capture high-quality brain signals without the need for gels. The device integrates real-time artifact removal algorithms and a low-power neuromorphic chip for seizure detection and prediction. The study will compare NEXA's performance against standard EEG monitoring in hospital settings across Oman, with the primary goal of determining its accuracy in seizure detection and prediction. Secondary outcomes include electrode comfort, usability, compliance, and safety. Data from this study will support regulatory submissions and demonstrate NEXA's potential as a practical and reliable solution for continuous EEG monitoring.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults (≥18 years) with a confirmed epilepsy diagnosis by a neurologist or epilepsy specialist.
- •History of active seizures within the last year, under stable treatment (medications, VNS, diet, or surgery) for at least 3 months.
- •Capacity to provide informed consent (or via legal representative if cognitively impaired).
- •Willingness to participate and sign consent.
- •Residents of Oman attending Khoula Hospital or affiliated clinics.
- •Stable general health without acute or severe comorbidities.
- •Ability and willingness to attend study visits and follow protocols.
排除标准
- •Seizures from non-epileptic causes (e.g., psychogenic, metabolic, tumors).
- •Under 18 years of age.
- •Severe cognitive impairment preventing consent or protocol adherence.
- •Pregnant or planning pregnancy during the study.
- •Severe uncontrolled medical conditions (e.g., heart disease, cancer).
- •History of non-compliance with epilepsy treatment or follow-ups.
- •Severe psychiatric disorders affecting participation or safety.
- •History of substance abuse interfering with study adherence.
- •Known allergies or hypersensitivity to study medications or procedures.
结局指标
主要结局
Accurate Seizure Detection in Real-World Patient Settings
时间窗: From start of patient data collection until end of clinical trial (estimated 3 months).
Measure the ability of the NEXA wearable EEG glasses to detect epileptic seizures in real-world patient settings with a target accuracy of ≥95%, using simultaneous hospital EEG recordings as the reference standard.
次要结局
未报告次要终点