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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
54
We will use a small, unobtrusive wearable (Sensor-Dot) to measure different biosignals (EEG, ECG, EMG, motion, skin temperature, respiration and oxygen saturation) for up to one year using newly developed skin adhesives and patches (Plug 'n Patch system)
UZ Leuven
Leuven, Vlaams-Brabant, Belgium
Epileptic seizures
In the hospital-based study, the investigators will compare the number epileptic seizures measured with the Sensor-Dot and Plug 'n Patch system in comparison with the hospital-based equipment.
Time frame: 5 days
Heart rate
In the hospital-based study, the investigators will compare the heartrate of participants measured with the Sensor-Dot and Plug 'n Patch system in comparison with hospital-based equipment.
Time frame: 5 days
Oxygen saturation
In the hospital-based study, the investigators will compare oxygen saturation of participants measured with a finger pulse oximetry versus the Sensor-Dot and Plug 'n Patch system.
Time frame: 5 days
Respiration
In the hospital-based study, the investigators will compare the respiration rate of participants measured with a chest belt during videoEEG registration versus the Sensor-Dot and Plug 'n Patch system.
Time frame: 5 days
Skin temperature
In the hospital-based study, the investigators will compare the skin temperature of participants using axillary measurement with a negative temperature coefficient thermistor versus the Sensor-Dot and Plug 'n Patch system, which is based on infrared thermometry.
Time frame: 5 days
Number of participants with adverse events and side effects
In the home-based study, 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
Time frame: 1 year
Total time that participants wear the Sensor-Dot and Plug 'n Patch system
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In the home-based study, 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
Time frame: 1 year
Cycles in epileptic seizure
To study whether epileptic seizures occur in recurring cycles or patterns
Time frame: 1 year
Cycles in interictal epileptic discharges
To study whether interictal epileptic discharges occur in recurring cycles or patterns
Time frame: 1 year
Cycles in sleep patterns
To study whether sleep occurs in recurring cycles or patterns
Time frame: 1 year
Cycles in body temperature
To study whether body temperature occurs in recurring cycles or patterns
Time frame: 1 year
Seizure forecasting
To study whether cycles in epileptic seizures, interictal epileptic discharges, sleep and skin temperature allow to define a pro-ictal state during which the occurrence of epileptic seizures is more likely, i.e. seizure forecasting
Time frame: 1 year
Physiological changes during tonic-clonic seizures
To study changes in EEG, respiration, heart rate, skin temperature and oxygen saturation during tonic-clonic seizures
Time frame: 1 year
Catamenial epilepsy
To determine if changes in IEDs, skin temperature, sleep cycles can define seizure recurrence in women with catamenial epilepsy
Time frame: 1 year