Wearable Epileptic Seizure Prediction and Alert Glasses Based on Neuromorphic Computing

NCT07139457 | Active Not Recruiting

• 2 other identifiers: MoH/CSR/25/29835Khoula Hospital
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

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.

Conditions

Epilepsy; Epileptic Seizures; Focal Epilepsy

Outcome Measures

Primary Outcomes (1)

• Accurate Seizure Detection in Real-World Patient Settings

  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.

  From start of patient data collection until end of clinical trial (estimated 3 months).

Study Arms (3)

Young adults

EXPERIMENTAL

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.

Device: Wearable seizure prediction and alert glasses

middle-aged adults

EXPERIMENTAL

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.

Device: Wearable seizure prediction and alert glasses

Elderly adults

EXPERIMENTAL

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.

Device: Wearable seizure prediction and alert glasses

Interventions

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.

Also known as: NEXA glasses, wearable EEG glasses, neuromorphic seizure prediction device

Elderly adults; Young adults; middle-aged adults

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Oman Ministry of Health: lead

Study Sites (1)

Khoula Hospital

Muscat, Oman

Location

MeSH Terms

Conditions

Epilepsy; Seizures; Epilepsies, Partial

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Said Al-Mawali, PhD

  Oman Ministry of Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2025
• First Posted: August 24, 2025
• Study Start: August 10, 2025
• Primary Completion: October 20, 2025
• Study Completion: December 31, 2025
• Last Updated: October 7, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

OM (1)