Sensor-Dot and Plug 'n Patch Study in Epilepsy

Universitaire Ziekenhuizen KU Leuven

Status: Completed

Conditions: Epilepsy

Treatments: Device: Sensor-Dot and Plug 'n Patch system

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04642105

S64726

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 54 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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54 participants in 2 patient groups

Hospital-based study

Experimental group

Description:

The investigators will select 15 patients with refractory focal epilepsy who are admitted to the videoEEG room for longterm videoEEG recording as part of a presurgical evaluation. The Sensor-Dot and Plug 'n Patch recordings will be compared with the gold-standard videoEEG recordings.

Treatment:

Device: Sensor-Dot and Plug 'n Patch system

Home-based study

Experimental group

Description:

The investigators will select 30 patients with refractory focal epilepsy, 15 patients with refractory idiopathic generalized epilepsy and 15 patients with frequent tonic-clonic seizures, i.e. a group at increased risk for sudden unexpected death in epilepsy (SUDEP).

Treatment:

Device: Sensor-Dot and Plug 'n Patch system