Preliminary Testing of a Novel Device to Detect Epileptic Seizures

Epilepsy Clinical Trial

— PTEpD  

Official title:

Preliminary Testing of a Novel Device to Detect Epileptic Seizures

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02286271
• Other study ID #: CIP version 5.1
• Status: Completed
• Phase: N/A
• First received: November 4, 2014
• Last updated: May 5, 2017
• Start date: January 20, 2015
• Est. completion date: December 31, 2016

Study information

• Verified date: August 2016
• Source: University of Edinburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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..

Recruitment information / eligibility

• Status: Completed
• Enrollment: 117
• Est. completion date: December 31, 2016
• Est. primary completion date: December 31, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Months and older

Eligibility

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.

Related Conditions & MeSH terms

• Epilepsy
• Seizures

Locations

Country	Name	City	State
United Kingdom	Royal Hospital for Sick Children	Edinburgh
United Kingdom	Western General Hospital	Edinburgh

Sponsors (2)

Lead Sponsor	Collaborator
University of Edinburgh	NHS Lothian

Country where clinical trial is conducted

United Kingdom, 

References & Publications (2)

Hanna H.J, Black M, Sander J.W.S, Smithson W.H, Appleton R, Brown S, Fish D.R. The National Sentinel Clinical Audit of Epilepsy-Related Death- Death in the Shadows. The Stationery Office. The National Sentinel of Epilepsy-Related Deaths Report 2002 ISBN 0-117-02868-1

Langan Y, Nashef L, Sander JW. Sudden unexpected death in epilepsy: a series of witnessed deaths. J Neurol Neurosurg Psychiatry. 2000 Feb;68(2):211-3. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reliable detection of epileptic seizures (Trigger level to be determined for total seizures)	Trigger level to be determined for total seizures	14 months
Secondary	Reliable detection of epileptic seizures (Trigger level to be determined for different types of seizures.)	Trigger level to be determined for different types of seizures.	14 months