EpilepsyPTEpDNCT02286271
Preliminary Testing of a Novel Device to Detect Epileptic Seizures
An observational study of Epilepsy, run by University of Edinburgh at 2 sites in United Kingdom.
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). Read more about this study
- Who is it for?
- Ages 3 months and older
- Conditions the study is for
- Epilepsy
- How many people
- 117 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 20 Jan 2015to 31 Dec 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 months and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- Frequent epileptic seizures 3 months and older Informed consent for participation
Who cannot join
- Infrequent seizures Attacks are of a non-epileptic nature Younger than 3 months Has an implantable device No informed consent.
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Western General Hospital
Edinburgh, EH4 2XU
Royal Hospital for Sick Children
Edinburgh, EH9 1LF
About this study
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.
Read the 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
- Keywords
- Seizure detection
- Medical subject headings
- Epilepsy
What is being measured
The primary outcome is the main question the study is designed to answer.
Reliable detection of epileptic seizures (Trigger level to be determined for total seizures)
Trigger level to be determined for total seizures
Measured: 14 months
Secondary outcomes (1)
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.
Measured: 14 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2014 (estimated)
- Study start20 Jan 2015
- Primary completion31 Dec 2016
- Study completion31 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- More trials run by University of EdinburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Edinburgh
- Sponsor type
- University, hospital or other
- Collaborators
- NHS Lothian
- Responsible party
- Sponsor
- Investigators
- Peter AG Sandercock, BA,BM, BCh, Study chair, University of Edinburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02286271
- Sponsor's protocol ID
- CIP version 5.1
- Acronym
- PTEpD
- Status last verified
- Aug 2016
- First submitted
- 4 Nov 2014
- Last updated
- 8 May 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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. doi: 10.1136/jnnp.68.2.211.
PubMed 10644790
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preliminary Testing of a Novel Device to Detect Epileptic Seizures
- ClinicalTrials.gov ID
- NCT02286271
- Acronym / sponsor ID
- PTEpD / CIP version 5.1
- Conditions
- Epilepsy
- Keywords
- Seizure detection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 117 participants (actual)
- Lead sponsor
- University of EdinburghUniversity, hospital or other
- Collaborators
- NHS Lothian
- Study start
- 20 Jan 2015 (actual)
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 31 Dec 2016 (actual)
- First posted
- 7 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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..
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 3 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Frequent epileptic seizures 3 months and older Informed consent for participation
Key exclusion criteria (1 listed)
- Infrequent seizures Attacks are of a non-epileptic nature Younger than 3 months Has an implantable device No informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
Reliable detection of epileptic seizures (Trigger level to be determined for different types of seizures.)
Time frame: 14 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2017.
- BackgroundHanna 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
- Background: PubMed 10644790Langan 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter AG Sandercock, BA,BM, BCh study chair
University of Edinburgh
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Epilepsy, run by University of Edinburgh at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reliable detection of epileptic seizures (Trigger level to be determined for total seizures) (time frame: 14 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02286271, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2017.