Epilepsy, Epileptic Seizures, Focal Epilepsy
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICEWearable seizure prediction and alert glasses
A glasses-based wearable EEG system using the international 10-20 electrode placement standard with 4 dry spiked electrodes at F7, F8, T3 and T4. The device integrates neuromorphic computing for real-time seizure prediction, an artifact removal algorithm, and multi-modal alerts (vibration, light, sound). Data is logged for model improvement. The system is intended for continuous use in both hospital-monitored and daily-life settings.
Sponsors
Oman Ministry of Health
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Accurate Seizure Detection in Real-World Patient Settings | 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. |
Countries
Oman
Outcome results
None listed