Clinical trial NCT02286271: Preliminary Testing of a Novel Device to Detect Epileptic Seizures
Official title: Preliminary Testing of a Novel Device to Detect Epileptic Seizures
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Epilepsy
Keywords: Seizure detection
Lead sponsor: University of Edinburgh
Sponsor class: OTHER
Collaborators: name: NHS Lothian
First posted: 2014-11-07
Enrollment: 117
Sex: ALL
Minimum age (years): 3
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who are being admitted for electroencephalographic videotelemetry as part of their clinical management of their epilepsy will be invited to participate in the study.

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..

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.

Primary outcomes:
measure: Reliable detection of epileptic seizures (Trigger level to be determined for total seizures)
timeFrame: 14 months
Secondary outcomes:
measure: Reliable detection of epileptic seizures (Trigger level to be determined for different types of seizures.)
timeFrame: 14 months
Other outcomes:
Locations:
city: Edinburgh
country: United Kingdom
facility: Western General Hospital
city: Edinburgh
country: United Kingdom
facility: Royal Hospital for Sick Children
Study officials:
affiliation: University of Edinburgh
name: Peter AG Sandercock, BA,BM, BCh
role: STUDY_CHAIR
References:
citation: 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
citation: 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.