Validation Study of the Simplified Seizure Classification Algorithm

NCT03796520 | Completed DMC

• 1 other identifier: EpiPick-1
• Study Type: observational
• Target: 240
• Locations: 4 countries
• Sites: 5

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.

Conditions

Epilepsy

Outcome Measures

Primary Outcomes (1)

• AC1

  Agreement coefficient between index test (EpiPick) and the reference standard (expert classification)

  Through study completion, an average of 8 months.

Study Arms (1)

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.

Diagnostic Test: EpiPick simplified seizure classification algorithm

Interventions

EpiPick simplified seizure classification algorithm DIAGNOSTIC_TEST

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.

Patients suspected for epilepsy

Eligibility Criteria

• Age: 10 Years - 120 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• patients referred to the participating centers on suspicion of epilepsy

You may not qualify if:

• none

Sponsors & Collaborators

• Sándor Beniczky: lead
• Danish Epilepsy Centre: collaborator
• Shiraz University of Medical Sciences: collaborator
• University of Pavia: collaborator
• Thomas Jefferson University: collaborator

Study Sites (5)

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Aarhus University Hospital

Aarhus, 8000, Denmark

Location

Danish Epilepsy Centre

Dianalund, 4293, Denmark

Location

Shiraz University of Medical Sciences

Shiraz, Iran

Location

University of Pavia

Pavia, 27100, Italy

Location

Related Publications (7)

• 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.

  PMID: 28276060 BACKGROUND

• 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.

  PMID: 26507832 BACKGROUND

• 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.

  PMID: 21763207 BACKGROUND

• 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.

  PMID: 19853218 BACKGROUND

• 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.

  PMID: 19800848 BACKGROUND

• 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.

  PMID: 28677857 BACKGROUND

• 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.

  PMID: 34420206 DERIVED

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Sandor Beniczky, MD, PhD

  Aarhus University Hospital

  PRINCIPAL INVESTIGATOR

• Guido Rubboli, MD, PhD

  Danich Epilepsy Centre

  PRINCIPAL INVESTIGATOR

• Michael Sperling, MD, PhD

  Thomas Jefferson University

  PRINCIPAL INVESTIGATOR

• Emilio Perucca, MD, PhD

  University of Pavia

  PRINCIPAL INVESTIGATOR

• Ali A Asadi-Pooya, MD, PhD

  Shiraz University of Medical Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: January 2, 2019
• First Posted: January 8, 2019
• Study Start: June 2, 2019
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: February 17, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: After publication.

Locations

IT (1); US (1); IR (1); DK (2)