Preliminary Testing of a Novel Device to Detect Epileptic Seizures

Solo los usuarios registrados pueden traducir artículos

Iniciar sesión Registrarse

El enlace se guarda en el portapapeles.

EstadoTerminado

Patrocinadores

University of Edinburgh

Colaboradores

NHS Lothian

ENSAYO CLÍNICO: NCT02286271

BioSeek: NCT02286271

Palabras clave

Abstracto

Official statistics report around 1000 deaths due to epilepsy in the UK each year (Hanna et al 2002). Most of these deaths are un-witnessed and in many cases are believed to have been avoidable with timely assistance (Langan et al 2000). A major problem is detecting nocturnal seizures to allow body re-positioning, to maintain an open airway and to administer rescue medication. There are several seizure alarms commercially available but are often unreliable with many false alarms. The aim of this study is to investigate a novel seizure detection system with a unique algorithm.

Descripción

Two duplicate novel medical devices conforming to safety regulation BS EN 60601 containing the unique algorithm will be evaluated in clinical trials at two hospitals over a 14 month period. Each device is time synchronised with an Electroencephalographic (EEG) videotelemetry system which is the gold standard in identifying different seizure types recording from scalp electrodes. The devices will be monitoring participants from 3 months and older (children and adults). The algorithm was created from results from a PhD where 527 seizures were categorised into different seizure types. Sensitivity of identifying seizures was 91% and specificity was 75% using an optimal trigger level and algorithm. This trial will investigate how reliable the algorithm is in practice and determine an optimal trigger level..

fechas

Verificado por última vez:	07/31/2016
Primero enviado:	11/03/2014
Inscripción estimada enviada:	11/05/2014
Publicado por primera vez:	11/06/2014
Última actualización enviada:	05/04/2017
Última actualización publicada:	05/07/2017
Fecha de inicio real del estudio:	01/19/2015
Fecha estimada de finalización primaria:	12/30/2016
Fecha estimada de finalización del estudio:	12/30/2016

Condición o enfermedad

Epilepsy

Fase

Criterio de elegibilidad

Edades elegibles para estudiar	3 Months A 3 Months
Sexos elegibles para estudiar	All
Método de muestreo	Non-Probability Sample
Acepta voluntarios saludables	si
Criterios	Inclusion Criteria: - Frequent epileptic seizures 3 months and older Informed consent for participation Exclusion Criteria: - Infrequent seizures Attacks are of a non-epileptic nature Younger than 3 months Has an implantable device No informed consent.

Salir

Medidas de resultado primarias

1. Reliable detection of epileptic seizures (Trigger level to be determined for total seizures) [14 months]

Trigger level to be determined for total seizures

Medidas de resultado secundarias

1. Reliable detection of epileptic seizures (Trigger level to be determined for different types of seizures.) [14 months]

Trigger level to be determined for different types of seizures.