Status:

COMPLETED

Computational Decision Support in Epilepsy Using Retrospective EEG

Lead Sponsor:

Cornwall Partnership NHS Foundation Trust

Collaborating Sponsors:

Neuronostics Ltd

Conditions:

Epilepsy

Eligibility:

All Genders

18+ years

Brief Summary

The primary aim is to validate a set of computational biomarkers as potential decision support in epilepsy on a large cohort of study participants that were diagnosed with epilepsy and controls that e...

Detailed Description

Mathematical models provide a powerful and useful tool with which to identify and understand biological mechanisms that may lead to the risk of having seizures as well as how they generate, propagate ...

Eligibility Criteria

Inclusion

  • Subject was suspected of having had a seizure or epilepsy (fits, faints or funny turns), and as part of the diagnostic process one or more EEGs was recorded The subject ended up with a confirmed diagnosis of epilepsy or of the differential diagnosis such as syncope, or psychogenic seizures (diagnosis must have been at least 1 year ago, and not changed since)
  • For each subject identified we would like to have all the available EEG files within the centre, with the following metadata:
  • Primary meta-data (crucial):
  • Age at the subject at time of each available EEG Treatment status at the time of each available EEG (including drug-load) Gender of the individual Ethnicity of the individual Confirmed diagnosis: details on the exact diagnosis made (syndrome and or condition)
  • Secondary meta-data (optional):
  • Aim of each available EEG at the time Information on whether any other conditions are present such as Alzheimer's disease, schizophrenia, Intellectual Disability If available: information on when the diagnosis was made If available: interpretation of each available EEG
  • Specifics for the EEG recordings:
  • Montage (10-20 preferred) Number of channels (minimum 19 channels) Referencing method (common average preferred) Format of the file (EDF preferred) Consistent channel labels for all EEGs provided from each centre Information concerning the time of day during the recording Information on the sampling frequency Faulty channels (not more than 2 preferred, all should be indicated though) Pre-processing details (information as to whether any filters were used, for example)

Exclusion

  • Subject was not suspected of having had a seizure or epilepsy Unavailable information concerning the final diagnosis of the subject (epilepsy or other) Incomplete or unreliable meta-data, such as the age, gender and treatment-status at the time of the EEG recording (primary meta-data) Recordings which do not comply with inclusion criteria

Key Trial Info

Start Date :

December 1 2019

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

March 31 2022

Estimated Enrollment :

825 Patients enrolled

Trial Details

Trial ID

NCT05384782

Start Date

December 1 2019

End Date

March 31 2022

Last Update

May 20 2022

Active Locations (1)

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1

Cornwall Partnership NHS Foundation Trust

Bodmin, Cornwall, United Kingdom, PL31 2QN