Ignite Creation Date:
2025-12-25 @ 4:13 AM
Ignite Modification Date:
2026-02-22 @ 5:49 AM
Study NCT ID:
NCT03796520
Status:
COMPLETED
Last Update Posted:
2021-02-17
First Post:
2019-01-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Validation Study of the Simplified Seizure Classification Algorithm
Sponsor:
Sándor Beniczky
Organization:
Study Overview
Official Title:
Clinical Validation Study of the Simplified Seizure Classification Algorithm
Status:
COMPLETED
Status Verified Date:
2021-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VASSCA
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.
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: