A multicenter study to examine clinical scenarios for long-term monitoring of epileptic seizures with a wearable biopotential technology

Not Applicable

• Conditions: G40.2; Localization-related (focal)(partial) symptomatic epilepsy and epileptic syndromes with complex partial seizures

• Registration Number: DRKS00025547
• Lead Sponsor: Department of Neurology, UZ Leuven

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-08-05
• Study Completion: 2022-06-30
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 495

Inclusion Criteria

1.Adults (>18 years old) who have given informed consent. Adults unable to provide consent or illiterate individuals can participate provided a caregiver or proxy can give informed consent.
2.Children (4-18 years old), if a parent can provide consent.
3.Refractory epilepsy, including refractory idiopathic absence epilepsy with typical absences (childhood absence or juvenile absence epilepsy)
4.Patients with focal epilepsy, who will undergo a presurgical evaluation

Exclusion Criteria

1.Inability to provide written informed consent, either directly or via a guardian.
2.Known allergy to electrodes used as part of the study protocol.
3.Having an implanted device, including (but not limited to) a pacemaker, cardioverter defibrillator (ICD), and/or neural stimulation device
4.Any other condition or finding that would compromise the safety of the participant or the quality of the study data, or otherwise interfere with achieving the study objectives, as determined by the investigator or research coordinator.
5.Pregnant women, neonates, employees or students of the participating enrolment centres, prisoners, and individuals whose first language is not English or that of the host country.

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
IN-HOSPITAL VALIDATION STUDY<br>To determine the F1-score of seizure annotations based on data from the wearable (Sensor Dot) versus video-EEG for: 1. Absence seizures, 2. Focal impaired awareness seizures, 3. Tonic-clonic seizures, during A. wakefulness and B. sleep<br><br>OUTPATIENT/HOME-BASED VALIDATION STUDY<br>To compare seizure annotations based on data from the wearable (Sensor Dot) versus patient-reported seizure frequency (seizure e-diary) for: 1. Absence seizures, 2. Focal impaired awareness seizures, 3. Tonic-clonic seizures, during A. wakefulness and B. sleep

Secondary Outcome Measures

Name	Time	Method
•To assess Sensor Dot’s durability and usability<br>•To assess seizure duration and severity<br>•To assess the seizure e-diary<br>•To develop automated seizure detection algorithms