Wearable Epileptic Seizure Prediction and Alert Glasses Based on Neuromorphic Computing

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Epilepsy Brain Diseases Central Nervous System Diseases Epilepsies, Partial Epileptic Seizures Focal Epilepsy Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Seizures Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Khoula Hospital

Muscat, Oman

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Wearable seizure prediction and alert glasses

Device

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.

Other names: NEXA glasses, wearable EEG glasses, neuromorphic seizure prediction device

Primary outcomes

Accurate Seizure Detection in Real-World Patient Settings

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Oman Ministry of Health

Other Gov

Registry information

Acronym: WESPG

Important dates

Study start: 2025
Primary completion: 2025
Study completion: 2025
First posted: Aug 24, 2025
Registry last updated: Oct 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Recruiting