<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03796520</url>
  </required_header>
  <id_info>
    <org_study_id>EpiPick-1</org_study_id>
    <nct_id>NCT03796520</nct_id>
  </id_info>
  <brief_title>Validation Study of the Simplified Seizure Classification Algorithm</brief_title>
  <acronym>VASSCA</acronym>
  <official_title>Clinical Validation Study of the Simplified Seizure Classification Algorithm</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sándor Beniczky</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Danish Epilepsy Centre</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Shiraz University of Medical Sciences</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Pavia</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Thomas Jefferson University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Aarhus University Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      An algorithm has been developed for simplified classification of epileptic seizures, in order&#xD;
      to optimize choice of antiepileptic drugs.&#xD;
&#xD;
      The objective of this study was to clinically validate the algorithm.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Optimal choice of antiepileptic drugs (AEDs) depend on the patients´ seizure-types. Over the&#xD;
      last four decades, several classification systems have been proposed for epileptic seizures.&#xD;
      The recent position paper of the International League Against Epilepsy defines 63&#xD;
      seizure-types. While this complex system might be useful for detailed phenotyping, currently&#xD;
      there is no evidence that each of these seizure-types needs different clinical management&#xD;
      strategy, and many clinicians find it difficult to implement.&#xD;
&#xD;
      To help physicians with optimizing the choice of AEDs, the investigators developed a&#xD;
      simplified seizure classification, consisting of the minimal number of seizure-types,&#xD;
      necessary for choice of AEDs, and the investigators developed an algorithm that identifies&#xD;
      the patient´s seizure-type, based on a set of 10 simple questions, that can be answered by&#xD;
      physicians even without extensive training in epilepsy. The current form of the algorithm was&#xD;
      developed for patients whose seizures started in adolescence or adulthood (at the age of 10&#xD;
      years or older).&#xD;
&#xD;
      In this study, the investigators aim to validate the diagnostic algorithm, by comparing the&#xD;
      seizure-type identified by the algorithm with the diagnosis and seizure-type as defined by&#xD;
      trained experts, in the clinical workup of the patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 2, 2019</start_date>
  <completion_date type="Actual">December 31, 2020</completion_date>
  <primary_completion_date type="Actual">December 31, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>AC1</measure>
    <time_frame>Through study completion, an average of 8 months.</time_frame>
    <description>Agreement coefficient between index test (EpiPick) and the reference standard (expert classification)</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">240</enrollment>
  <condition>Epilepsy</condition>
  <arm_group>
    <arm_group_label>Patients suspected for epilepsy</arm_group_label>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>EpiPick simplified seizure classification algorithm</intervention_name>
    <description>EpiPick simplified seizure classification algorithm input:&#xD;
Grey matter brain lesion Exclusively nocturnal seizures First seizure at age &gt; 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.</description>
    <arm_group_label>Patients suspected for epilepsy</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The study population includes patients referred to the participating centers on suspicion&#xD;
        of epilepsy, provided their seizure onset was at 10 years of age or older.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients referred to the participating centers on suspicion of epilepsy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  none&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>10 Years</minimum_age>
    <maximum_age>120 Years</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Sandor Beniczky, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Aarhus University Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Guido Rubboli, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Danich Epilepsy Centre</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Michael Sperling, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Thomas Jefferson University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Emilio Perucca, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Pavia</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ali A Asadi-Pooya, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Shiraz University of Medical Sciences</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Thomas Jefferson University</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19107</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aarhus University Hospital</name>
      <address>
        <city>Aarhus</city>
        <zip>8000</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Danish Epilepsy Centre</name>
      <address>
        <city>Dianalund</city>
        <zip>4293</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shiraz University of Medical Sciences</name>
      <address>
        <city>Shiraz</city>
        <country>Iran, Islamic Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Pavia</name>
      <address>
        <city>Pavia</city>
        <zip>27100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
    <country>Iran, Islamic Republic of</country>
    <country>Italy</country>
    <country>United States</country>
  </location_countries>
  <reference>
    <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>
    <PMID>28276060</PMID>
  </reference>
  <reference>
    <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>
    <PMID>26507832</PMID>
  </reference>
  <reference>
    <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>
    <PMID>21763207</PMID>
  </reference>
  <reference>
    <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>
    <PMID>19853218</PMID>
  </reference>
  <reference>
    <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>
    <PMID>19800848</PMID>
  </reference>
  <reference>
    <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>
    <PMID>28677857</PMID>
  </reference>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>January 2, 2019</study_first_submitted>
  <study_first_submitted_qc>January 4, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 8, 2019</study_first_posted>
  <last_update_submitted>February 16, 2021</last_update_submitted>
  <last_update_submitted_qc>February 16, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 17, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Aarhus University Hospital</investigator_affiliation>
    <investigator_full_name>Sándor Beniczky</investigator_full_name>
    <investigator_title>professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Seizures</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Age, gender, EpiPick diagnostic score, EpiPick seizure classification, reference standard, result of EEG, result of MRI.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_time_frame>After publication.</ipd_time_frame>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03796520
org study id: EpiPick-1
nct id: NCT03796520
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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.
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.
observational model: Case-Only
time perspective: Prospective
measure: AC1
time frame: Through study completion, an average of 8 months.
description: Agreement coefficient between index test (EpiPick) and the reference standard (expert classification)
arm group label: Patients suspected for epilepsy
description: 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.
intervention type: Diagnostic Test
intervention name: EpiPick simplified seizure classification algorithm
description: 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.
arm group label: Patients suspected for epilepsy
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 10 Years
maximum age: 120 Years
last name: Sandor Beniczky, MD, PhD
role: Principal Investigator
affiliation: Aarhus University Hospital
last name: Guido Rubboli, MD, PhD
role: Principal Investigator
affiliation: Danich Epilepsy Centre
last name: Michael Sperling, MD, PhD
role: Principal Investigator
affiliation: Thomas Jefferson University
last name: Emilio Perucca, MD, PhD
role: Principal Investigator
affiliation: University of Pavia
last name: Ali A Asadi-Pooya, MD, PhD
role: Principal Investigator
affiliation: Shiraz University of Medical Sciences
facility: 
facility: 
facility: 
facility: 
facility: 
country: Denmark
country: Iran, Islamic Republic of
country: Italy
country: United States
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.
PMID: 28276060
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.
PMID: 26507832
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.
PMID: 21763207
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.
PMID: 19853218
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.
PMID: 19800848
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.
PMID: 28677857
responsible party type: Sponsor-Investigator
investigator affiliation: Aarhus University Hospital
investigator full name: Sándor Beniczky
investigator title: professor
mesh term: Seizures
sharing ipd: Yes
ipd description: Age, gender, EpiPick diagnostic score, EpiPick seizure classification, reference standard, result of EEG, result of MRI.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd time frame: After publication.