Preliminary Testing of a Novel Device to Detect Epileptic Seizures

NCT ID: NCT02286271

Last Updated: 2017-05-08

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 117 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-01-20
• Study Completion Date: 2016-12-31

Brief 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.

Detailed 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..

Conditions

Epilepsy

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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.

• Minimum Eligible Age: 3 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NHS Lothian

OTHER_GOV

Sponsor Role: collaborator

University of Edinburgh

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Peter AG Sandercock, BA,BM, BCh

Role: STUDY_CHAIR

University of Edinburgh

Locations

Western General Hospital

Edinburgh, , United Kingdom

Royal Hospital for Sick Children

Edinburgh, , United Kingdom

Countries

United Kingdom

References

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

Reference Type: BACKGROUND

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. doi: 10.1136/jnnp.68.2.211.

Reference Type: BACKGROUND

PMID: 10644790 (View on PubMed)

Other Identifiers

CIP version 5.1

Identifier Type: -

Identifier Source: org_study_id