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Validation Study of the Simplified Seizure Classification Algorithm (VASSCA)

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ClinicalTrials.gov Identifier: NCT03796520
Recruitment Status : Recruiting
First Posted : January 8, 2019
Last Update Posted : January 8, 2019
Sponsor:
Collaborators:
Danish Epilepsy Centre
Shiraz University of Medical Sciences
University of Pavia
Thomas Jefferson University
Information provided by (Responsible Party):
Sándor Beniczky, Aarhus University Hospital

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.


Condition or disease Intervention/treatment
Epilepsy Diagnostic Test: EpiPick simplified seizure classification 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.


Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Clinical Validation Study of the Simplified Seizure Classification Algorithm
Actual Study Start Date : April 2, 2018
Estimated Primary Completion Date : January 31, 2019
Estimated Study Completion Date : February 28, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy Seizures

Group/Cohort Intervention/treatment
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

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.





Primary Outcome Measures :
  1. AC1 [ Time Frame: Through study completion, an average of 8 months. ]
    Agreement coefficient between index test (EpiPick) and the reference standard (expert classification)



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Ages Eligible for Study:   10 Years to 120 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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.
Criteria

Inclusion Criteria:

  • patients referred to the participating centers on suspicion of epilepsy

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03796520


Contacts
Contact: Sandor Beniczky, MD, PhD +4526981536 sbz@filadelfia.dk
Contact: Guido Rubboli, MD, PhD +4520649116 guru@filadelfia.dk

Locations
United States, Pennsylvania
Thomas Jefferson University Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Michael Sperling, MD, PhD       Michael.Sperling@jefferson.edu   
Denmark
Aarhus University Hospital Recruiting
Aarhus, Denmark, 8000
Contact: Sandor Beniczky, MD PhD    26981536    sbz@filadelfia.dk   
Danish Epilepsy Centre Recruiting
Dianalund, Denmark, 4293
Contact: Guido Rubboli, MD, PhD    +4520649116    guru@filadelfia.dk   
Iran, Islamic Republic of
Shiraz University of Medical Sciences Recruiting
Shiraz, Iran, Islamic Republic of
Contact: Ali A Asadi-Pooya, MD, PhD       aliasadipooya@yahoo.com   
Italy
University of Pavia Recruiting
Pavia, Italy, 27100
Contact: Emilio Perucca, MD, PhD       perucca@unipv.it   
Sponsors and Collaborators
Sándor Beniczky
Danish Epilepsy Centre
Shiraz University of Medical Sciences
University of Pavia
Thomas Jefferson University
Investigators
Principal Investigator: 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

Publications:
Responsible Party: Sándor Beniczky, professor, Aarhus University Hospital
ClinicalTrials.gov Identifier: NCT03796520     History of Changes
Other Study ID Numbers: EpiPick-1
First Posted: January 8, 2019    Key Record Dates
Last Update Posted: January 8, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Age, gender, EpiPick diagnostic score, EpiPick seizure classification, reference standard, result of EEG, result of MRI.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: After publication.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Seizures
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms