EpiCare@Home Validation Study for Focal Onset Seizures (NCT05738226) | Clinical Trial Compass
WithdrawnNot Applicable
EpiCare@Home Validation Study for Focal Onset Seizures
Stopped: No enrollment
United States0Started 2023-01-23
Plain-language summary
The goal of this clinical trial is to validate a wearable seizure monitoring device, EpiCare@Home, as an objective seizure monitoring tool for people with focal onset epileptic seizures. The device continuously records brain, cardiorespiratory, and physical activity data.
The study aims to 1) collect benchmark data for seizure detection algorithm development and validation, and 2) evaluate the performance of the device in clinical and at home workflows.
Participants will wear the device during a routine Epilepsy Monitoring Unit (EMU) admission. Additionally, they can continue wearing the device at home after the EMU admission.
Who can participate
Age range
12 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:
* Adult (age ≥ 18) and adolescent (12 ≤ age \< 18) patients with a known history or suspicion of focal onset epilepsy, including focal-to-bilateral tonic-clonic seizures
* A clinical indication for ≥ 1 h EMU observation.
* Participants should be able to maintain a seizure diary in the provided EpiCare@Home Patient App (themselves or via a caregiver). Alternatively, the use of a paper seizure diary is allowed.
Exclusion Criteria:
* Inability to provide written informed consent, either direct or via a proxy.
* Known allergy or skin-sensitivity to the materials used in the Byteflies Adhesives or any 3rd party biopotential electrode.
* Having an implanted device may be grounds for exclusion, depending on the type and location of the implant. Implanted devices, such as (but not limited to) pacemakers, cardioverter defibrillators (ICD), and/or neural stimulation devices may contain magnetic switches. Byteflies Sensor Dots contain magnets that may interfere with the operation of these devices. The chance of this happening based on the strength of the magnets is exceedingly low (for comparison, the magnet strength is 10x lower than what is found in Apple Magsafe cases) but it has not been excluded by formal testing either. The risk will be evaluated on a case-by-case basis.
* Any other condition or finding that would compromise the safety of the participant or the quality of the study data, or otherwise interfere with achieving the study objectives, as determin…
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
Sensitivity of algorithmic detection of potential epileptic events on EpiCare@Home data as compared to video-EEG ground truth annotations.
Timeframe: From EMU admission to discharge, up to 10 days
2
Sensitivity of algorithmic detection of potential epileptic events on a subset of temporal lobe epilepsy EpiCare@Home study participants as compared to video-EEG ground truth annotations.
Timeframe: From EMU admission to discharge, up to 10 days
3
Specificity of the classification of potential epileptic events as seizures by two independent trained reviewers as compared to video-EEG ground truth annotations.
Timeframe: From EMU admission to discharge, up to 10 days