Validation Study of the Simplified Seizure Classification Algorithm (VASSCA)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03796520|
Recruitment Status : Recruiting
First Posted : January 8, 2019
Last Update Posted : January 8, 2019
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|
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|
|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|
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.
- AC1 [ Time Frame: Through study completion, an average of 8 months. ]Agreement coefficient between index test (EpiPick) and the reference standard (expert classification)
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
|Contact: Sandor Beniczky, MD, PhDemail@example.com|
|Contact: Guido Rubboli, MD, PhDfirstname.lastname@example.org|
|United States, Pennsylvania|
|Thomas Jefferson University||Recruiting|
|Philadelphia, Pennsylvania, United States, 19107|
|Contact: Michael Sperling, MD, PhD Michael.Sperling@jefferson.edu|
|Aarhus University Hospital||Recruiting|
|Aarhus, Denmark, 8000|
|Contact: Sandor Beniczky, MD PhD 26981536 email@example.com|
|Danish Epilepsy Centre||Recruiting|
|Dianalund, Denmark, 4293|
|Contact: Guido Rubboli, MD, PhD +4520649116 firstname.lastname@example.org|
|Iran, Islamic Republic of|
|Shiraz University of Medical Sciences||Recruiting|
|Shiraz, Iran, Islamic Republic of|
|Contact: Ali A Asadi-Pooya, MD, PhD email@example.com|
|University of Pavia||Recruiting|
|Pavia, Italy, 27100|
|Contact: Emilio Perucca, MD, PhD firstname.lastname@example.org|
|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|