Sensor-Dot and Plug 'n Patch Study in Epilepsy

NCT04642105 | Completed

• 1 other identifier: S64726
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Epilepsy

Outcome Measures

Primary Outcomes (7)

• 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.

  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.

  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.

  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.

  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.

  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

  1 year

• Total time that participants wear the Sensor-Dot and Plug 'n Patch system

  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

  1 year

Secondary Outcomes (7)

• Cycles in epileptic seizure

  1 year

• Cycles in interictal epileptic discharges

  1 year

• Cycles in sleep patterns

  1 year

• Cycles in body temperature

  1 year

• Seizure forecasting

  1 year

Study Arms (2)

Hospital-based study

EXPERIMENTAL

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.

Device: Sensor-Dot and Plug 'n Patch system

Home-based study

EXPERIMENTAL

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).

Device: Sensor-Dot and Plug 'n Patch system

Interventions

Sensor-Dot and Plug 'n Patch system DEVICE

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)

Home-based study; Hospital-based study

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead
• Byteflies: collaborator

Study Sites (1)

UZ Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

Location

Related Publications (6)

• Paesschen WV. The future of seizure detection. Lancet Neurol. 2018 Mar;17(3):200-202. doi: 10.1016/S1474-4422(18)30034-6. No abstract available.

  PMID: 29452676 BACKGROUND

• Verdru J, Van Paesschen W. Wearable seizure detection devices in refractory epilepsy. Acta Neurol Belg. 2020 Dec;120(6):1271-1281. doi: 10.1007/s13760-020-01417-z. Epub 2020 Jul 6.

  PMID: 32632710 BACKGROUND

• Mikkelsen KB, Ebajemito JK, Bonmati-Carrion MA, Santhi N, Revell VL, Atzori G, Della Monica C, Debener S, Dijk DJ, Sterr A, de Vos M. Machine-learning-derived sleep-wake staging from around-the-ear electroencephalogram outperforms manual scoring and actigraphy. J Sleep Res. 2019 Apr;28(2):e12786. doi: 10.1111/jsr.12786. Epub 2018 Nov 13.

  PMID: 30421469 BACKGROUND

• Gu Y, Cleeren E, Dan J, Claes K, Van Paesschen W, Van Huffel S, Hunyadi B. Comparison between Scalp EEG and Behind-the-Ear EEG for Development of a Wearable Seizure Detection System for Patients with Focal Epilepsy. Sensors (Basel). 2017 Dec 23;18(1):29. doi: 10.3390/s18010029.

  PMID: 29295522 BACKGROUND

• De Cooman T, Vandecasteele K, Varon C, Hunyadi B, Cleeren E, Van Paesschen W, Van Huffel S. Personalizing Heart Rate-Based Seizure Detection Using Supervised SVM Transfer Learning. Front Neurol. 2020 Feb 26;11:145. doi: 10.3389/fneur.2020.00145. eCollection 2020.

  PMID: 32161573 BACKGROUND

• Vandecasteele K, De Cooman T, Dan J, Cleeren E, Van Huffel S, Hunyadi B, Van Paesschen W. Visual seizure annotation and automated seizure detection using behind-the-ear electroencephalographic channels. Epilepsia. 2020 Apr;61(4):766-775. doi: 10.1111/epi.16470. Epub 2020 Mar 11.

  PMID: 32160324 BACKGROUND

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Wim Van Paesschen, MD, PhD

  UZ Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Hospital-based study: 15 patients will be selected in this study which will last 5 days. Home-based study: 60 patients will be selected in this study which will last a maximum of 1 year.

Study Record Dates

• First Submitted: October 26, 2020
• First Posted: November 24, 2020
• Study Start: March 1, 2021
• Primary Completion: May 6, 2024
• Study Completion: May 6, 2024
• Last Updated: May 8, 2024

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data wil be shared after the end of the study. We do not foresee an end-date.
• Access Criteria: Data will be made available upon request to researchers who provide a methodologically sound proposal. Proposals should be directed to Wim.vanpaesschen@uzleuven.be

Locations

BE (1)