Wearable Epileptic Seizure Prediction and Alert Glasses Based on Neuromorphic Computing (NCT07139457) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Wearable Epileptic Seizure Prediction and Alert Glasses Based on Neuromorphic Computing
Oman47 participantsStarted 2025-08-10
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Accurate Seizure Detection in Real-World Patient Settings
Timeframe: From start of patient data collection until end of clinical trial (estimated 3 months).