Validation of Criteria for Identification of Epileptiform Discharges in EEG Recordings of Patients With Epilepsy

NCT03533374 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2020-07-22

Study results available
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Summary

Electroencephalography (EEG) records electric activity of the brain using electrodes placed on the scalp. EEG is an important tool in the diagnostic work-up of patients with epilepsy. Specific types of sharp EEG discharges (epileptiform discharges) are associated with patients with epilepsy.

The International Federation of Clinical Neurophysiology (IFCN) has recently published a set of six operational criteria for identifying epileptiform discharges. At least four criteria need to be present in order to classify a discharge as epileptiform. These criteria are largely based on expert opinion and have not been validated yet. It is not clear what the sensitivity and specificity of these criteria are, and which combination of these criteria are optimal. Each criterion is based on visual assessment. However, it is not known what the inter-rater agreement of these criteria are.

EEG is traditionally inspected in sensor space, i.e. in the recording channels. Advances in signal analysis made possible reconstructing the electric currents in the regions of the brain generating them, and displaying the signals in the source space, instead of the sensor space.

The objectives of this study are: to determine the inter-rater agreement of the IFCN criteria by visual analysis in sensor space, to determine the combination of criteria with the best accuracy (sensitivity and specificity) and assess the accuracy of evaluating the discharges in source space.

The raters will analyze EEG recordings from 100 patients, from two groups: consecutive patients with epilepsy and consecutive patients with non-epileptic paroxysmal episodes. EEG was recorded during long-term video-EEG monitoring. As reference standard, the investigators used the evaluation of the patients´ habitual clinical episode. The performance of the criteria in sensor-space and the analysis in source space will be compared with the unrestricted expert scorings.

Conditions

Interventions

DIAGNOSTIC_TEST

Electroencephalogram (EEG) and visual evaluation

Electroencephalogram (EEG) was recorded using Nicolet-One system, and the standard 25-electrode array. Recordings with sharp transients are inspected by experts (physicians).

Sponsors & Collaborators

  • Aarhus University Hospital

    collaborator OTHER
  • Central Denmark Region

    collaborator OTHER
  • Filadelfia Epilepsy Hospital

    collaborator OTHER
  • University Health Network, Toronto

    collaborator OTHER
  • University Hospital Erlangen

    collaborator OTHER
  • Oslo University Hospital

    collaborator OTHER
  • Sándor Beniczky

    lead OTHER

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-01
Primary Completion
2018-01-01
Completion
2018-01-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03533374 on ClinicalTrials.gov