Clinical Validation of zEEG, a Wireless EEG Recording System for Pediatric and Adult Patients Wit… (NCT05123469) | Clinical Trial Compass
UnknownNot Applicable
Clinical Validation of zEEG, a Wireless EEG Recording System for Pediatric and Adult Patients With Epilepsy
United States30 participantsStarted 2022-01
Plain-language summary
The purpose of this study is to compare the standard clinical electroencephalography (EEG) device with a new portable wireless EEG device, further referred to as zEEG, made by ZETO®. zEEG was designed to make EEG studies simpler, safer, more comfortable, faster, and less obstructive for the patient, also easier to set up for technicians. Wireless and battery powered, it uses the latest mobile technology. Contrary to the clinical EEG, this headset does not use any glue between the skin and the electrodes. Minor skin irritation may still occur but much less likely than from the collodion glue used in the clinical electrodes. In addition, the zEEG system does not need any gel to be applied to the skin. The zEEG electrodes are dry and disposable. They have never been used on any other head before. No additional risk is involved with setting it up. In addition to the clinically necessary EEG electrodes or intracranial electrodes for long term monitoring, we will place zEEG on the head to compare the sensitivity of the new device to the traditional device. zEEG is proven to meet the standard of clinical system and received an FDA clearance in 2018. If further clinical tests validate its technical parameters and comfort, it may replace traditional clinical EEG systems.
Who can participate
Age range
1 Year – 99 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:
* Patients with the diagnosis of simple and multifocal seizure or generalized seizure who are at least 1 year old but 19 years old at most, whose head the zEEG headset fits, and who also produced sufficient seizure and normal activity EEG data. This age range is all-inclusive, because the actual patient selection will be based on the head-sizes that the zEEG system will fit to.
Exclusion Criteria:
* Patients younger than 1 year and older than 19 years, pseudo seizures, patients who did not generate normal EEG data or their EEG electrode setting is in conflict with the zEEG headset will be excluded. Patients who cannot keep the zEEG headset on their head will be excluded.
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.