Sensor-Dot and Plug 'n Patch Study in Epilepsy

Launched by UNIVERSITAIRE ZIEKENHUIZEN KU LEUVEN · Nov 18, 2020

Keywords

ClinConnect Summary

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 t...

Gender

ALL

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.