Clinical Scenarios for Long-term Monitoring of Epileptic Seizures With a Wearable Biopotential Technology (SeizeIT2)

Universitaire Ziekenhuizen KU Leuven

Status: Completed

Conditions: Epilepsy

Treatments: Device: Sensor Dot

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04284072

S63631

Details and patient eligibility

About

Clinically validate a biopotential and motion recording wearable device (Byteflies Sensor Dot) for detection of epileptic seizures in the epilepsy monitoring unit (EMU) and at home.

Full description

Subjects with refractory epilepsy who are admitted to the Epilepsy Monitoring Unit (EMU) for clinically-indicated long-term video-EEG assessment will be simultaneously monitored with Sensor Dots to record electroencephalographic (EEG), electrocardiographic (ECG), electromyographic (EMG), and motion signals.

A subset of subjects will continue using Sensor Dot devices at home (Home Phase) after completing the EMU Phase.

The data recorded by Sensor Dots will be used to: 1) annotate epileptic seizures, which will be compared to the annotations made as part of routine EMU monitoring and seizure diaries kept at home, and 2) to develop seizure detection algorithms. The data collected as part of this study will not be used to influence clinical decision making.

Enrollment: 496 patients

Sex: All

Ages: 4+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects (4+ years old) with refractory epilepsy who are admitted to the hospital for clinically-indicated long-term video-EEG assessment or presurgical evaluation, and a high likelihood of experiencing seizures during the EMU Phase
• For subjects continuing into the Home Phase: successful recording of their habitual seizures with Sensor Dot during the EMU Phase
• For subjects continuing into the Home Phase: the ability to keep an e-diary

Exclusion criteria

• Known allergies to any of the biopotential electrodes or adhesives used as part of the study protocol
• Having an implanted device, such as (but not limited to) a pacemaker, cardioverter defibrillator (ICD), and/or neural stimulation device because Sensor Dot contains magnets that could interfere with the operation of these devices
• Women who are pregnant

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Sequential Assignment

Masking: None (Open label)

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496 participants in 1 patient group

All subjects

Experimental group

Description:

Single arm study with a device intervention for epileptic seizure monitoring in subjects with refractory focal impaired awareness, tonic-clonic, and/or typical absence seizures.

Treatment:

Device: Sensor Dot