NCT04642105Completed
Sensor-Dot and Plug 'n Patch Study in Epilepsy
Multimodal Profiling of People With Epilepsy to Determine Which Signals Are Clinically Useful for Long-term Home Monitoring
Source: ClinicalTrials.gov · Last updated 8 May 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 54 (actual)
- First submitted
- 26 Oct 2020
- Start date
- 1 Mar 2021
- Primary completion date
- 6 May 2024
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Diseases
- Epilepsy
- NCT number
- NCT04642105
What you commit to
- Study type: Interventional
- Participants enrolled: 54
- From 1 Mar 2021 to the primary completion date, 6 May 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Known allergy to electrodes and patches.
Other
- Inability to provide written informed consent or assent.
- Implanted device, such as a pacemaker, cardioverter defibrillator (ICD), and/or neural stimulation device.
Who the study is looking for
- 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.
Age in the registry: 16 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| UZ Leuven Coordinator of this site? Confirm its status | Leuven | Belgium | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.