Validation Study of the Simplified Seizure Classification Algorithm

Completed

• Conditions: Epilepsy

• Registration Number: NCT03796520
• Lead Sponsor: Sándor Beniczky

Brief Summary

An algorithm has been developed for simplified classification of epileptic seizures, in order to optimize choice of antiepileptic drugs.

The objective of this study was to clinically validate the algorithm.

Detailed Description

Optimal choice of antiepileptic drugs (AEDs) depend on the patients´ seizure-types. Over the last four decades, several classification systems have been proposed for epileptic seizures. The recent position paper of the International League Against Epilepsy defines 63 seizure-types. While this complex system might be useful for detailed phenotyping, currently there is no evidence that each of these seizure-types needs different clinical management strategy, and many clinicians find it difficult to implement.

To help physicians with optimizing the choice of AEDs, the investigators developed a simplified seizure classification, consisting of the minimal number of seizure-types, necessary for choice of AEDs, and the investigators developed an algorithm that identifies the patient´s seizure-type, based on a set of 10 simple questions, that can be answered by physicians even without extensive training in epilepsy. The current form of the algorithm was developed for patients whose seizures started in adolescence or adulthood (at the age of 10 years or older).

In this study, the investigators aim to validate the diagnostic algorithm, by comparing the seizure-type identified by the algorithm with the diagnosis and seizure-type as defined by trained experts, in the clinical workup of the patients.

Study Timeline

• Study First Submitted: 2019-01-02
• Study First Submitted QC: 2019-01-04
• Study First Posted: 2019-01-08
• Study Start: 2019-06-02
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-16
• Last Update Posted: 2021-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

• patients referred to the participating centers on suspicion of epilepsy

Exclusion Criteria

• none

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
AC1	Through study completion, an average of 8 months.	Agreement coefficient between index test (EpiPick) and the reference standard (expert classification)

Trial Locations

Locations (5)

Thomas Jefferson University; 🇺🇸 Philadelphia, Pennsylvania, United States

Aarhus University Hospital; 🇩🇰 Aarhus, Denmark

Danish Epilepsy Centre; 🇩🇰 Dianalund, Denmark

Shiraz University of Medical Sciences; 🇮🇷 Shiraz, Iran, Islamic Republic of

University of Pavia; 🇮🇹 Pavia, Italy