Validation Study of the Simplified Seizure Classification Algorithm

Study Overview
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Brief Summary
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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
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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.

Official Title
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Clinical Validation Study of the Simplified Seizure Classification Algorithm

Conditions
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Epilepsy

Intervention / Treatment
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* Diagnostic Test: EpiPick simplified seizure classification algorithm


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients referred to the participating centers on suspicion of epilepsy Exclusion Criteria: none

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients suspected for epilepsy<br>The cohort includes patients referred to the participating centers on suspicion of epilepsy, provided their seizure onset was at 10 years of age or older. | Diagnostic Test: EpiPick simplified seizure classification algorithm<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AC1 | Agreement coefficient between index test (EpiPick) and the reference standard (expert classification) | Through study completion, an average of 8 months. |