EpiCare@Home Validation Study for Focal Onset Seizures

Inclusion Criteria:

• Adult (age ≥ 18) and adolescent (12 ≤ age < 18) patients with a known history orsuspicion of focal onset epilepsy, including focal-to-bilateral tonic-clonicseizures

• A clinical indication for ≥ 1 h EMU observation.

• Participants should be able to maintain a seizure diary in the provided EpiCare@HomePatient App (themselves or via a caregiver). Alternatively, the use of a paperseizure 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 Adhesivesor any 3rd party biopotential electrode.

• Having an implanted device may be grounds for exclusion, depending on the type andlocation of the implant. Implanted devices, such as (but not limited to) pacemakers,cardioverter defibrillators (ICD), and/or neural stimulation devices may containmagnetic switches. Byteflies Sensor Dots contain magnets that may interfere with theoperation of these devices. The chance of this happening based on the strength ofthe magnets is exceedingly low (for comparison, the magnet strength is 10x lowerthan what is found in Apple Magsafe cases) but it has not been excluded by formaltesting either. The risk will be evaluated on a case-by-case basis.

• Any other condition or finding that would compromise the safety of the participantor the quality of the study data, or otherwise interfere with achieving the studyobjectives, as determined by the investigator or research coordinator.