Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 3:09 AM
Ignite Modification Date:
2025-12-25 @ 3:09 AM
NCT ID:
NCT04642105
Brief Summary:
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.
Detailed 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.
Study:
NCT04642105
Study Brief:
Protocol Section:
NCT04642105