Clinical trial NCT03796520: Validation Study of the Simplified Seizure Classification Algorithm
Official title: Clinical Validation Study of the Simplified Seizure Classification Algorithm
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Epilepsy
Lead sponsor: Aarhus University Hospital
Sponsor class: OTHER
Collaborators: name: Danish Epilepsy Centre
name: Shiraz University of Medical Sciences
name: University of Pavia
name: Thomas Jefferson University
First posted: 2019-01-08
Enrollment: 240
Sex: ALL
Minimum age (years): 10
Maximum age (years): 120
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population includes patients referred to the participating centers on suspicion of epilepsy, provided their seizure onset was at 10 years of age or older.

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.

Eligibility criteria: Inclusion Criteria:

* patients referred to the participating centers on suspicion of epilepsy

Exclusion Criteria:

* none

Primary outcomes:
measure: AC1
timeFrame: Through study completion, an average of 8 months.
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
city: Dianalund
country: Denmark
facility: Danish Epilepsy Centre
city: Shiraz
country: Iran, Islamic Republic of
facility: Shiraz University of Medical Sciences
city: Pavia
country: Italy
facility: University of Pavia
Study officials:
affiliation: Aarhus University Hospital
name: Sandor Beniczky, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Danich Epilepsy Centre
name: Guido Rubboli, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Thomas Jefferson University
name: Michael Sperling, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pavia
name: Emilio Perucca, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Shiraz University of Medical Sciences
name: Ali A Asadi-Pooya, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fisher RS, Cross JH, French JA, Higurashi N, Hirsch E, Jansen FE, Lagae L, Moshe SL, Peltola J, Roulet Perez E, Scheffer IE, Zuberi SM. Operational classification of seizure types by the International League Against Epilepsy: Position Paper of the ILAE Commission for Classification and Terminology. Epilepsia. 2017 Apr;58(4):522-530. doi: 10.1111/epi.13670. Epub 2017 Mar 8.
citation: Brodie MJ. Practical Use of Newer Antiepileptic Drugs as Adjunctive Therapy in Focal Epilepsy. CNS Drugs. 2015 Nov;29(11):893-904. doi: 10.1007/s40263-015-0285-4.
citation: Brodie MJ, Covanis A, Gil-Nagel A, Lerche H, Perucca E, Sills GJ, White HS. Antiepileptic drug therapy: does mechanism of action matter? Epilepsy Behav. 2011 Aug;21(4):331-41. doi: 10.1016/j.yebeh.2011.05.025. Epub 2011 Jul 16.
citation: Stephen LJ, Brodie MJ. Selection of antiepileptic drugs in adults. Neurol Clin. 2009 Nov;27(4):967-992. doi: 10.1016/j.ncl.2009.06.007.
citation: Brodie MJ, Elder AT, Kwan P. Epilepsy in later life. Lancet Neurol. 2009 Nov;8(11):1019-30. doi: 10.1016/S1474-4422(09)70240-6. Epub 2009 Oct 1.
citation: Beniczky S, Rubboli G, Aurlien H, Hirsch LJ, Trinka E, Schomer DL; SCORE consortium. The new ILAE seizure classification: 63 seizure types? Epilepsia. 2017 Jul;58(7):1298-1300. doi: 10.1111/epi.13799. No abstract available.
citation: Beniczky S, Asadi-Pooya AA, Perucca E, Rubboli G, Tartara E, Meritam Larsen P, Ebrahimi S, Farzinmehr S, Rampp S, Sperling MR. A web-based algorithm to rapidly classify seizures for the purpose of drug selection. Epilepsia. 2021 Oct;62(10):2474-2484. doi: 10.1111/epi.17039. Epub 2021 Aug 22.