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OpenTrials
Completed

NCT Number: NCT02286271

Preliminary Testing of a Novel Device to Detect Epileptic Seizures

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.

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Key information

Conditions

Epilepsy Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

3 month and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Royal Hospital for Sick Children, Edinburgh, United Kingdom

Loading trial locations.

About this study

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..

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

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

    Time frame: 14 months

    Trigger level to be determined for total seizures

Secondary outcomes

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

    Time frame: 14 months

    Trigger level to be determined for different types of seizures.

Sponsors and collaborators

Lead sponsor

University of Edinburgh

Other

Collaborators

  • NHS Lothian

Registry information

Acronym: PTEpD

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Nov 7, 2014
Registry last updated
May 8, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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