Validation Study of the Simplified Seizure Classification Algorithm
NCT ID: NCT03796520
Last Updated: 2021-02-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
240 participants
OBSERVATIONAL
2019-06-02
2020-12-31
Brief Summary
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The objective of this study was to clinically validate the algorithm.
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Detailed Description
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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.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Patients suspected for epilepsy
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.
EpiPick 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.
Interventions
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EpiPick 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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
10 Years
120 Years
ALL
No
Sponsors
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Danish Epilepsy Centre
UNKNOWN
Shiraz University of Medical Sciences
OTHER
University of Pavia
OTHER
Thomas Jefferson University
OTHER
Sándor Beniczky
OTHER
Responsible Party
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Sándor Beniczky
professor
Principal Investigators
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Sandor Beniczky, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Aarhus University Hospital
Guido Rubboli, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Danich Epilepsy Centre
Michael Sperling, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Thomas Jefferson University
Emilio Perucca, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Pavia
Ali A Asadi-Pooya, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Shiraz University of Medical Sciences
Locations
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Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Aarhus University Hospital
Aarhus, , Denmark
Danish Epilepsy Centre
Dianalund, , Denmark
Shiraz University of Medical Sciences
Shiraz, , Iran
University of Pavia
Pavia, , Italy
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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EpiPick-1
Identifier Type: -
Identifier Source: org_study_id
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