Ignite Creation Date:
2025-12-24 @ 6:59 PM
Ignite Modification Date:
2025-12-25 @ 4:32 PM
Study NCT ID:
NCT07139457
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-10-07
First Post:
2025-08-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Wearable Epileptic Seizure Prediction and Alert Glasses Based on Neuromorphic Computing
Sponsor:
Oman Ministry of Health
Organization:
Study Overview
Official Title:
Wearable Epileptic Seizure Prediction and Alert Glasses Based on Neuromorphic Computing
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
WESPG
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| Khoula Hospital | OTHER | Oman MoH | View |