epilepsy epilepsie
Conditions
Interventions
The study will be conducted at three clinical centres in Europe (CHUV (Switzerland), KLI (Austria), SEIN (the Netherlands)). Patients will be recruited at the epilepsy in- and outpatient clinics. They
Sponsors
Stichting Epilepsie Instellingen Nederland (SEIN)
Eligibility
Age
2 Years to 99 Years
Inclusion criteria
Inclusion criteria: age >4 years = 1 seizure in the last 12 monthsExtension to home monitoring beneficial for one of the following reasons: Evaluation of seizure typeEvaluation of seizure burden and frequency
Exclusion criteria
Exclusion criteria: Inability to comply with the trial proceduresInability to give informed consent Pregnant and breastfeeding patientsNeed to undergo an MRI scan or cardiac defibrillationActive implanted device such as a pacemaker, defibrillator, or vagal nerve, or brain stimulatorAllergy or skin-sensitivity to the materials used in the Byteflies Adhesives (standard medical adhesive)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome parameters are the recording duration and number of interactions in relation to what is expected in the clinical protocol (phase 1: three days of ambulatory video EEG monitoring, phase 2: 14 days of reduced EEG montage wearable, phase 3: 14 days of solely telehealth platform (31 days in total), and daily interactions with the platform to log sleep and seizure diary). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcome parameters will be data quality and clinical utility, both rated by clinicians. We want to explore user acceptance, usability, engagement, data transmission, reliability, and other technical aspects using relevant outcome parameters and standardized scores. | — |
Countries
Austria, Netherlands, Switzerland
Contacts
Public ContactD van Blooijs
Stichting Epilepsie Instellingen Nederland (SEIN)
Outcome results
None listed