Development of a multimodal seizure detection instrument to improve safety and disease management of epilepsy patients at home

Completed

Conditions: epilepsy
seizures
10039911

Registration Number: NL-OMON35980

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 100

Inclusion Criteria

Patients with refractory epilepsy and nocturnal seizures who are referred for clinical video-EEG seizure recordings to the epilepsy monitoring unit of one of the participating centers.

Exclusion Criteria

Self-reported nocturnal seizure frequency must be at least 1 per week. The patient or parents/legal representatives must be capable of understanding Dutch and filling in questionnaires, and must be able to provide informed consent.

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The outcome parameter is the performance (in terms of sensitivity and positive<br /><br>predictive value) of the MSDI against the gold standard of nocturnal video-EEG<br /><br>recording, so the association between seizures detected by the MSDI and<br /><br>seizures detected by video-EEG.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints are:<br /><br>(1) User friendliness measured by questionnaires on the valued aspects of the<br /><br>system and on potential objections.<br /><br>(2) Inventory of the expectations of the performance of a seizure detection<br /><br>device from patients and caregivers and clinicians.</p><br>