Wearable Epileptic Seizure Prediction and Alert Glasses Based on Neuromorphic Computing (WESPG)

Oman Ministry of Health

Status: Active, not recruiting

Conditions: Epilepsy; Focal Epilepsy; Epileptic Seizures

Treatments: Device: Wearable seizure prediction and alert glasses

Study type: Interventional

Funder types: Other

Identifiers

NCT07139457

MoH/CSR/25/29835

Khoula Hospital (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 47 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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47 participants in 3 patient groups

Young adults

Experimental group

Description:

Participants aged 18-30 (equal male and female distribution) who will wear the NEXA seizure prediction glasses during both hospital-monitored and daily-life phases. Intervention involves continuous EEG monitoring, real-time seizure prediction, and alert notifications.

Treatment:

Device: Wearable seizure prediction and alert glasses

middle-aged adults

Experimental group

Description:

Participants aged 31-60 (equal male and female distribution) who will wear the NEXA seizure prediction glasses during both hospital-monitored and daily-life phases. Intervention involves continuous EEG monitoring, real-time seizure prediction, and alert notifications.

Treatment:

Device: Wearable seizure prediction and alert glasses

Elderly adults

Experimental group

Description:

Participants aged 60+ (equal male and female distribution) who will wear the NEXA seizure prediction glasses during both hospital-monitored and daily-life phases. Intervention involves continuous EEG monitoring, real-time seizure prediction, and alert notifications.

Treatment:

Device: Wearable seizure prediction and alert glasses