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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02286271
Other study ID # CIP version 5.1
Secondary ID
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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