Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:09 AM
Ignite Modification Date:
2025-12-25 @ 3:09 AM
NCT ID:
NCT04642105
Eligibility Criteria:
Inclusion Criteria:
* Patients who are 18 years of age or older, who signed an informed consent form, and teenagers over 16 years of age who assent, with their parents signing an informed consent form, and:
* Epilepsy syndrome: idiopathic generalized epilepsy (n=15), patients at increased risk for SUDEP, i.e. have more than 1 nocturnal tonic clonic seizures (TCS) per month (n=15), refractory focal epilepsy with a presurgical evaluation at UZ Leuven (n=30)
* Minimum one seizure per month
* Patient is able and motivated to handle the Sensor-Dot and Plug 'n Patch system independently, to fill out the Helpilepsy app on a daily basis and to wear the Sensor-Dot and Plug 'n Patch system for a full year 24/24-7/7; fallback option for patients for whom wearing the device during the day is too obtrusive: measurement only during the evening and nighttime.
Exclusion Criteria:
* Inability to provide written informed consent or assent.
* Known allergy to electrodes and patches.
* Implanted device, such as a pacemaker, cardioverter defibrillator (ICD), and/or neural stimulation device.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
16 Years
Study:
NCT04642105
Study Brief:
Protocol Section:
NCT04642105