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Validation Study of the Simplified Seizure Classification Algorithm

Clinical Validation Study of the Simplified Seizure Classification Algorithm

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03796520
Acronym
VASSCA
Enrollment
240
Registered
2019-01-08
Start date
2019-06-02
Completion date
2020-12-31
Last updated
2021-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epilepsy

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.

Interventions

DIAGNOSTIC_TESTEpiPick simplified seizure classification algorithm

EpiPick simplified seizure classification algorithm input: Grey matter brain lesion Exclusively nocturnal seizures First seizure at age \> 20 years Lip smacking or chewing during seizures Staring with impaired awareness, lasting less than 20s without postictal confusion Sudden irregular jerks, in isolation or brief series, if none of the following applies: Are the jerks consistently in the same limb? When resting in bed when falling asleep? Bilateral tonic-clonic seizures within 1h of awakening or immediately preceded by irregular jerks Any of the following is present: Skin turning pale pre-ictally; Loss of consciousness immediately after urination or defecation; Sudden slump with loss of awareness, lasting less than 10 seconds; Seizure lasting longer than 10 minutes, with eyes closed throughout the seizure; Severe pre-ictal headache; Episodes consisting of falls that occur always after change in posture to the upright position, or coughing or feeling pain.

Sponsors

Danish Epilepsy Centre
CollaboratorUNKNOWN
Shiraz University of Medical Sciences
CollaboratorOTHER
University of Pavia
CollaboratorOTHER
Thomas Jefferson University
CollaboratorOTHER
Sándor Beniczky
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
10 Years to 120 Years

Inclusion criteria

* patients referred to the participating centers on suspicion of epilepsy

Exclusion criteria

* none

Design outcomes

Primary

MeasureTime frameDescription
AC1Through study completion, an average of 8 months.Agreement coefficient between index test (EpiPick) and the reference standard (expert classification)

Countries

Denmark, Iran, Italy, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 14, 2026