EpiCare@Home Validation Study for Focal Onset Seizures

Launched by BYTEFLIES · Feb 10, 2023

Keywords

ClinConnect Summary

The EpiCare@Home Validation Study is testing a new wearable device designed to monitor seizures in people with focal onset epilepsy. This device records important information about brain activity, breathing, and movement continuously, both in a hospital setting and at home. The main goals of the study are to gather data that will help improve how the device detects seizures and to see how well it works for patients during their regular activities.

To participate in this study, individuals must be at least 12 years old and have a known history or suspicion of focal onset epilepsy, which includes certain types of seizures. Participants will wear the device while staying in the Epilepsy Monitoring Unit (EMU) for at least one hour, and they can also continue using it at home. They’ll be asked to keep track of their seizures using a special app or a paper diary. It’s important for potential participants to know that certain medical conditions or implanted devices might prevent them from joining the trial, but this will be assessed on a case-by-case basis.

Gender

ALL

Eligibility criteria

• 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 determined by the investigator or research coordinator.