AzTrials
AzTrials

Automatic Seizure DetectionNEEDNCT04647825

NEED: Neuromed Epilepsy EEG Database. A Large EEG Database of Epilepsy Patients for Research Community.

An observational study of Automatic Seizure Detection, run by Neuromed IRCCS at 1 site in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

For one-third of patients with drug-resistant epilepsy alternative approaches must be investigated in order to improve the quality of their life. A possible approach is to find automatic methods to detect/predict seizures, in order to adopt interventional actions to stop or abort the seizure or to limit its side… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Automatic Seizure Detection
What is being tested?
Collection of data from non-invasive epilepsy monitoring
How many people
200 participants
Where
1 siteItaly
Study dates
1 Apr 2021to 30 Jan 2023
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Drug-resistant epilepsy patients underwent presurgical monitoring at Epilepsy Surgery Unit at IRCCS Neuromed

Who may be able to join

  • Patients with drug-resistant epilepsy candidate to the surgery underwent to non-invasive EEG monitoring
  • Patients with at least one recorded seizure during the EEG monitoring

Who cannot join

  • Patients with drug-resistant epilepsy candidate to the surgery underwent to non-invasive EEG monitoring
  • Patients with no recorded seizure during the EEG monitoring

Trial locations and contacts

1 site in 1 country.

Italy1 site, 1 recruiting
  • Irccs Neuromed

    Pozzilli, IS, 86077

    LUIGI PAVONE, +39 0865929645, bioingegneria@neuromed.it

    Luigi Pavone

    Recruiting

Other trials in Italy

About this study

Official title: NEED: Neuromed Epilepsy EEG Database. A Large Database of Electroencephalographic (EEG) Signals of Epilepsy Patients for Research Community.

For one-third of patients with drug-resistant epilepsy alternative approaches must be investigated in order to improve the quality of their life. A possible approach is to find automatic methods to detect/predict seizures, in order to adopt interventional actions to stop or abort the seizure or to limit its side effect. The main problem in this case is to evaluate the reproducibility of such methods and to standardize them, because there is a lack of availability of long-term electroencephalography (EEG) data. In this study we want to create a large long-term EEG database, called NEED (Neuromed Epilepsy EEG Database), whos aim is to give researchers a way to test their method in a large collection of data. The database will contain long-term EEG recordings of 200 patients as well as extensive metadata and standardized annotation of the data sets and will be made freely available for the download to the research community.

Read the detailed description

About 50 million people worldwide are affected by epilepsy, which is one of the most frequent neurological diseases. It is characterized by unpredictable and sudden seizures which could led to loss of consciousness and uncontrolled motor reactions, severely impacting the quality of life of epilepsy patients. Only two-thirds of epilepsy patients can control seizures with anti-epileptic drugs or through epilepsy surgery. For the remaining patients, other therapeutics approaches should be considered. These approaches include the development of interventional closed-loop device, able to detect seizures and trigger an interventional operation, such as administer anti-epileptic drugs or electrically stimulate the epileptogenic focus to abort the seizure. In order to provide efficient therapeutic approaches to these patients, in the last decades many efforts have been made to develop automatic methods to find reliable markers in electroencephalographic (EEG) signal, which is the gold standard for epilepsy diagnosis, able to predict or early detect seizures in EEG. Such methods are based on mathematical or computational approaches for EEG signal analysis, whose aim is to extract complex measures (the so-called "features") from EEG signal, which are not recognizable with classical visual inspection of EEG signals made by epileptologists during the diagnosis of epilepsy, in order to use such features as precursors of incoming seizures (seizure prediction) or as indicators of an ongoing seizure (seizure detection). Many methods have been proposed in the last years, using linear or non-linear, to extract features from EEG signal. Recently, some studies used also electrocardiographic signal (ECG), which is normally recorded together with EEG in epilepsy monitoring, in order to extract promising features from it. Although these studies showed promising results, nevertheless they suffer of many limitations. Among them, the use of a limited number of patients and seizures and the use of only recordings belonging to the phase preceding the seizures (the so - called pre-ictal period). Such limitations do not allow to determine, for example, the specificity of such algorithms, because they don't consider also recordings acquired in time intervals far from the seizures (inter-ictal data) and could led to a overfitting of the seizure prediction/detection model. The only thing on which all the researchers on epilepsy agree is the existence of a pre-ictal phase, which is the phase preceding the seizure, the ictal phase, where the seizure is "active" and inter-ictal phase, which is a period temporarily far from the seizure. Normally, automatic methods for seizure prediction/detection consist of three different phases: the pre-processing (artifact removal, band-pass filtering, data segmentation, …) of EEG signals, feature extraction and feature selection and classification. This last step usually consists in the use of machine-learning and statistical methods in order to make decision about the prediction/detection. Basically, these models should be able to classify each EEG instance in two classes, "seizure" or "no seizure", using the features extracted from EEG signal. The efficacy of these models highly depends on how efficiently they are trained and normally the more are the data used to trained them, the more they are able to take the right decision. Therefore, the availability of large database of data could allow to develop efficient models for epilepsy detection/prediction. The possibility for researchers to have access to large database of continuous and long-term EEG data of epilepsy patients could be a big opportunity to develop efficient and reliable automatic seizure prediction/detection methods. For these reasons, in the last years some research groups have proposed and shared public EEG database with researchers who wants to test their automated seizure detection/prediction models. In particular, such database have been proposed by Epilepsy Center of University of Bonn and Freiburg and also by Children's Hospital of Boston and have been made available for free downloading to researchers. These databases contain long-term EEG recordings acquired during pre-surgical monitor of epilepsy patients. The number of patients included in these databases is quite low (from a minimum of 5 to a maximum of 23 patients) and also the number of seizures is limited (from a minimum of 59 to a maximum of 189). Furthermore, the duration of the recordings ranges from 40 minutes to 142 hours and the number of metadata (other information about patients and seizures) is very low. The last database has been proposed in 2008 in the framework of a EU-founded project (EPILEPSIAE), in which 6 different partners (hospitals, universities, companies) of 4 different countries (Germany, Italy, France, Portugal) have been involved. This database is not free but is made available for the download upon payment in 2012. Nowadays, it is the largest epilepsy EEG database available worldwide (http://epilepsy-database.eu/). It contains data from 275 patients, including EEG and ECG recordings, metadata, clinical and technical annotations on the data and clinical information about the patients. Actually, only 60 out of 275 datasets are available for the download. The aim of this study is to create a long-term EEG database acquired on epilepsy patients during the non-invasive presurgical monitor at Epilepsy Surgery Unit at IRCCS Neuromed. The database will include, besides EEG and ECG recordings, clinical and technical annotations on the data made by expert epileptologists and also clinical information about the patient, including neuropsychological evaluations. All the data will be first anonymized, crypted and then made available for the free download. The database will include data from 200 epilepsy patients underwent non-invasive presurgical epilepsy monitoring at Epilepsy Surgery Unit at IRCCS Neuromed. At the end of non-invasive EEG monitoring, two expert epileptologists will inspect EEG/ECG data in order to identify the seizures, in particular the channels where the seizure starts and the time, and everything could be of interest for the project. All the recordings will be exported in ASCII (American Standard Code for Information Interchange) format using the DMS Data Management System (Nihon Kohden Europe Gmbh) software, version 2.9.8 and stored locally. At the same time, clinical and demographic (only gender and age) data will be acquired for each patient. In particular, for each patient the following data will be available:

  • Demographic data (gender and age);
  • Clinical information (epilepsy type, seizure frequency,…);
  • Neuropsychological data;
  • EEG data acquired according to international 10-20 system;
  • ECG data;
  • Information about the recordings and the seizures (start and end time, start and end time of each seizure, …)

All data from all the patients will be included in a single database, and each patient will be stored in a single compressed archive. The database will be made available after the completation of a request which can be forwarded by each researcher using a dedicated URL, in which the researcher will fill in a form when it will be asked to provide the following data:

  • Information about the applicant (name, address, affiliation, …)
  • GDPR consent Once the request will be received, the compressed archive containing the whole database will be protected with an ad-hoc alphanumeric password. Such password will consist of two parts: the first part will be sent by email to the applicant, the second part will be sent using the regular mail service (two-way authentication).
Being tested
Collection of data from non-invasive epilepsy monitoring

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Collection of data from non-invasive epilepsy monitoringOther

    Creation of a large long-term EEG database for seizure detection/prediction

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of collected patients

    Measured: December 2020 - December 2021

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Dec 2020
  2. Study start1 Apr 2021
  3. Primary completion31 Dec 2022 (estimated)
  4. Study completion30 Jan 2023 (estimated)

Resources

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
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04647825
Sponsor's protocol ID
BIOING_02
Acronym
NEED
Status last verified
Apr 2022
First submitted
23 Nov 2020
Last updated
8 Apr 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Stacey WC, Litt B. Technology insight: neuroengineering and epilepsy-designing devices for seizure control. Nat Clin Pract Neurol. 2008 Apr;4(4):190-201. doi: 10.1038/ncpneuro0750. Epub 2008 Feb 26.

    PubMed 18301414
  • Stein AG, Eder HG, Blum DE, Drachev A, Fisher RS. An automated drug delivery system for focal epilepsy. Epilepsy Res. 2000 Apr;39(2):103-14. doi: 10.1016/s0920-1211(99)00107-2.

    PubMed 10759298
  • Theodore WH, Fisher R. Brain stimulation for epilepsy. Acta Neurochir Suppl. 2007;97(Pt 2):261-72. doi: 10.1007/978-3-211-33081-4_29.

    PubMed 17691312
  • Osorio I, Frei MG, Sunderam S, Giftakis J, Bhavaraju NC, Schaffner SF, Wilkinson SB. Automated seizure abatement in humans using electrical stimulation. Ann Neurol. 2005 Feb;57(2):258-68. doi: 10.1002/ana.20377.

    PubMed 15668970
  • Morrell M. Brain stimulation for epilepsy: can scheduled or responsive neurostimulation stop seizures? Curr Opin Neurol. 2006 Apr;19(2):164-8. doi: 10.1097/01.wco.0000218233.60217.84.

    PubMed 16538091
  • Sunderam S, Gluckman B, Reato D, Bikson M. Toward rational design of electrical stimulation strategies for epilepsy control. Epilepsy Behav. 2010 Jan;17(1):6-22. doi: 10.1016/j.yebeh.2009.10.017. Epub 2009 Nov 17.

    PubMed 19926525
  • Mormann F, Andrzejak RG, Elger CE, Lehnertz K. Seizure prediction: the long and winding road. Brain. 2007 Feb;130(Pt 2):314-33. doi: 10.1093/brain/awl241. Epub 2006 Sep 28.

    PubMed 17008335
  • Rogowski Z, Gath I, Bental E. On the prediction of epileptic seizures. Biol Cybern. 1981;42(1):9-15. doi: 10.1007/BF00335153.

    PubMed 6799009
  • Salant Y, Gath I, Henriksen O. Prediction of epileptic seizures from two-channel EEG. Med Biol Eng Comput. 1998 Sep;36(5):549-56. doi: 10.1007/BF02524422.

    PubMed 10367436
  • Iasemidis LD, Sackellares JC, Zaveri HP, Williams WJ. Phase space topography and the Lyapunov exponent of electrocorticograms in partial seizures. Brain Topogr. 1990 Spring;2(3):187-201. doi: 10.1007/BF01140588.

    PubMed 2116818
  • Lehnertz K, Elger CE. Spatio-temporal dynamics of the primary epileptogenic area in temporal lobe epilepsy characterized by neuronal complexity loss. Electroencephalogr Clin Neurophysiol. 1995 Aug;95(2):108-17. doi: 10.1016/0013-4694(95)00071-6.

    PubMed 7649002
  • Martinerie J, Adam C, Le Van Quyen M, Baulac M, Clemenceau S, Renault B, Varela FJ. Epileptic seizures can be anticipated by non-linear analysis. Nat Med. 1998 Oct;4(10):1173-6. doi: 10.1038/2667.

    PubMed 9771751
  • Le Van Quyen M, Soss J, Navarro V, Robertson R, Chavez M, Baulac M, Martinerie J. Preictal state identification by synchronization changes in long-term intracranial EEG recordings. Clin Neurophysiol. 2005 Mar;116(3):559-68. doi: 10.1016/j.clinph.2004.10.014. Epub 2004 Dec 25.

    PubMed 15721070
  • Le Van Quyen M, Martinerie J, Baulac M, Varela F. Anticipating epileptic seizures in real time by a non-linear analysis of similarity between EEG recordings. Neuroreport. 1999 Jul 13;10(10):2149-55. doi: 10.1097/00001756-199907130-00028.

    PubMed 10424690
  • Stacey W, Le Van Quyen M, Mormann F, Schulze-Bonhage A. What is the present-day EEG evidence for a preictal state? Epilepsy Res. 2011 Dec;97(3):243-51. doi: 10.1016/j.eplepsyres.2011.07.012. Epub 2011 Aug 31.

    PubMed 21885253

Questions about this trial

What is this clinical trial studying?

An observational study of Automatic Seizure Detection, run by Neuromed IRCCS at 1 site in Italy.

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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 8 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of collected patients (time frame: December 2020 - December 2021). 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 NCT04647825, which also lists 19 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 Apr 2022.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in