Sensor-Dot and Plug 'n Patch Study in Epilepsy
Sensor-Dot and Plug 'n Patch Study in Epilepsy
The investigators plan to determine whether it is possible to use a small, unobtrusive
 wearable device (the Sensor Dot with Plug 'n Patch system) to follow-up epilepsy in the home
 environment through measurement of different biosignals (EEG, ECG, EMG, motion, skin
 temperature, respiration and oxygen saturation) for prolonged periods in patients with
 epilepsy. If this is possible, the investigators will study the chronobiology of epilepsy.
In this study, the investigators will make use of a small, discrete and unobtrusive wearable,
 the Sensor-Dot (https://www.byteflies.com/) and newly developed electrode patches (Plug 'n
 Patch system). The aim is multimodal profiling of people with epilepsy to determine which
 signals are clinically useful for long-term home monitoring. Biosignals that will be
 registered include EEG, EMG, and ECG, respiration, oxygen saturation, skin temperature and
 motion.

 The first part of the study is hospital-based and will last 5 days. The investigators will
 compare the biosignals of the Sensor Dot and the Plug 'n Patch system with those measured
 with hospital equipment. Participants are 15 patients with refractory focal epilepsy who will
 be admitted to the hospital for long-term videoEEG registration of epileptic seizures as part
 of a presurgical evaluation.

 The second part of the study is home-based and will last for a maximum of 1 year. Sixty
 participants will be selected with refractory idiopathic generalized epilepsy (n=15),
 refractory focal epilepsy (n=30) and frequent nocturnal tonic-clonic seizures (n=15). The aim
 is to determine and improve usability of the Sensor Dot and Plug 'n Patch system upon
 long-term use in the home environment. The investigators will determine the number of
 patients with side effects and adverse events of the Sensor Dot and Plug 'n Patch system,
 e.g. contact allergic eczema. The investigators will determine the total time that
 participants wear the Sensor Dot and Plug 'n Patch system, and the reason why participants do
 not wear it.

 The investigators further aim to determine whether epileptic seizures occur in cycles, and
 will study interactions between epilepsy and sleep. The investigators will also study whether
 body temperature occurs in recurring cycles and is related with the occurrence of epileptic
 seizures. The investigators will study changes in EEG, respiration, heart rate, skin
 temperature and oxygen saturation during tonic-clonic seizures. The investigators will
 determine whether it is possible that the Sensor-Dot and Plug 'n Patch system can be used as
 a seizure forecaster.
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.