xml: <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/NCT06017973</url>
    </required_header>
    <id_info>
      <org_study_id>S67933</org_study_id>
      <nct_id>NCT06017973</nct_id>
    </id_info>
    <brief_title>The Role of Imaging in the Diagnosis, Management and Prognosis of Possible Non-convulsive Status Epilepticus</brief_title>
    <official_title>The Role of Cerebral Functional, Structural and Spectral Imaging in the Diagnosis, Management and Prognosis of Status Epilepticus: a Prospective Study in Patients With the Ictal-interictal Continuum</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Universitaire Ziekenhuizen KU Leuven</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Universitaire Ziekenhuizen KU Leuven</source>
    <oversight_info>
      <has_dmc>No</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>
        The investigators propose a prospective study of 20 control subjects and 180 consecutive&#xD;
        patients with possible non-convulsive status epilepticus (NCSE). The investigators will&#xD;
        obtain three functional images of the brain:&#xD;
  &#xD;
          1. Fluorodeoxyglucose positron emission tomography (FDG-PET)&#xD;
  &#xD;
          2. Perfusion (and structural) magnetic resonance (MR) images&#xD;
  &#xD;
          3. Computed tomography (CT) perfusion.&#xD;
  &#xD;
        Brain hypermetabolism/hyperperfusion is a strong argument to confirm a diagnosis of&#xD;
        non-convulsive status epilepticus.&#xD;
  &#xD;
        The aim is to determine which of the three functional imaging techniques is the most&#xD;
        sensitive and easy to obtain in the detection of hypermetabolism/hyperperfusion. The&#xD;
        investigators will determine which EEG patterns are associated with&#xD;
        hypermetabolism/perfusion.&#xD;
  &#xD;
        The investigators will further study and describe the management with antiseizure medication&#xD;
        and outcome of the group with possible non-convulsive status epilepticus WITH&#xD;
        hypermetabolism/hyperperfusion versus the group with possible non-convulsive status&#xD;
        epilpticus WITHOUT hypermetabolism/hyperperfusion.&#xD;
  &#xD;
        The investigators will make recommendations for an imaging protocol in possible NCSE for&#xD;
        widespread use. The aim is to offer guidelines to incorporate imaging in the diagnosis,&#xD;
        management and prognosis of NCSE in patients with the ictal-interictal continuum.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 1, 2023</start_date>
    <completion_date type="Anticipated">September 30, 2027</completion_date>
    <primary_completion_date type="Anticipated">September 30, 2027</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Non-Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Diagnostic</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Sensitivity of MRI arterial spin labelling, CT perfusion and FDG-PET of the brain to detect hyperperfusion/hypermetabolism in possible non-convulsive status epilepticus</measure>
      <time_frame>Day 1</time_frame>
      <description>The investigators will determine which diagnostic test (MRI, CT or FDG-PET) is most sensitive in detecting hyperperfusion/hypermetabolism in possible non-convulsive status epilepticus to confirm a diagnosis of non-convulsive status epilepticus</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Correlation between FREQUENCY of ictal-interictal EEG patterns within 30 minutes after FDG-PET injection and standardised uptake value on FDG-PET.</measure>
      <time_frame>Day 1</time_frame>
      <description>The investigators will assess the correlation between standardised uptake value of the cerebral hypermetabolic region and the frequency of ictal-interictal EEG patterns within 30 minutes after injection of FDG. The frequency of ictal-interictal EEG patterns will be scored semi-quantitatively based on the American Clinical Neurophysiology Criteria (ACNS) criteria (2021).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Correlation between PREVALENCE of ictal-interictal EEG patterns on EEG within 30 minutes after FDG-PET injection and standardised uptake value on FDG-PET.</measure>
      <time_frame>Day 1</time_frame>
      <description>The investigators will assess the correlation between standardised uptake value of the cerebral hypermetabolic region and the prevalence of ictal-interictal EEG patterns within 30 minutes after injection of FDG. The prevalence of ictal-interictal EEG patterns will be scored semi-quantitatively based on the American Clinical Neurophysiology Criteria (ACNS) (2021)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>The seizure freedom of patients with hypermetabolism compared to those with hypometabolism within 24 hours after undergoing an FDG-PET scan.</measure>
      <time_frame>Day 1</time_frame>
      <description>The investigators will assess the seizure freedom of patients in the hypermetabolic vs hypometabolic group. Patients will receive video EEG-monitoring for 24 hours after FDG-PET. Seizures will be defined according to current American Clinical Neurophysiology Criteria (ACNS) (2021) based on electrographic and clinical data. Hypermetabolism/hypometabolism will be qualitatively scored by a trained nuclearist.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Correlation between SHARPNESS of ictal-interictal EEG patterns on EEG within 30 minutes after FDG-PET injection and standardised uptake value on FDG-PET.</measure>
      <time_frame>Day 1</time_frame>
      <description>The investigators will assess the correlation between standardised uptake value of the cerebral hypermetabolic region and the sharpness of ictal-interictal EEG patterns within 30 minutes after injection of FDG. The sharpness of ictal-interictal EEG patterns will be scored semi-quantitatively based on the American Clinical Neurophysiology Criteria (ACNS) (2021)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Correlation between AMPLITUDE of ictal-interictal EEG patterns within 30 minutes after FDG-PET injection and standardised uptake value on FDG-PET</measure>
      <time_frame>Day 1</time_frame>
      <description>The investigators will assess the correlation between standardised uptake value of the cerebral hypermetabolic region and the amplitude of ictal-interictal EEG patterns within 30 minutes after injection of FDG. The amplitude of ictal-interictal EEG patterns will be scored semi-quantitatively based on the American Clinical Neurophysiology Criteria (ACNS) (2021)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Correlation between EVOLUTION of ictal-interictal EEG patterns on EEG within 30 minutes after FDG-PET injection and standardised uptake value on FDG-PET.</measure>
      <time_frame>Day 1</time_frame>
      <description>The investigators will assess the correlation between standardised uptake value of the cerebral hypermetabolic region and evolution of ictal-interictal EEG patterns within 30 minutes after injection of FDG (i.e. static, fluctuating or evolving). The presence of fluctuation and evolution of ictal-interictal EEG patterns will be scored based on the American Clinical Neurophysiology Criteria (ACNS) (2021)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Functional imaging in possible non-convulsive status epilepticus and INTERICTAL BURDEN</measure>
      <time_frame>Day 7</time_frame>
      <description>The investigators will compare interictal burden, defined as a percentage of ictal-interictal EEG patterns during continuous EEG monitoring, in the group with possible non-convulsive status epilepticus WITH hypermetabolism/hyperperfusion versus the group with possible non-convulsive status epilepticus WITHOUT hypermetabolism/hyperperfusion</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Functional imaging in possible non-convulsive status epilepticus and ANTISEIZURE MEDICATION (ASM)</measure>
      <time_frame>Day 30</time_frame>
      <description>The investigators will document all changes in antiseizure medication and compare these in the group with possible non-convulsive status epilepticus WITH hypermetabolism/hyperperfusion versus the group with possible non-convulsive status epilepticus WITHOUT hypermetabolism/hyperperfusion</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Functional imaging in possible non-convulsive status epilepticus and OUTCOME</measure>
      <time_frame>Day 7</time_frame>
      <description>The investigators will compare modified rankin scale (mRS) (0: no symptoms, 1: no significant disability, 2: slight disability, 3: moderate disability, 4: moderately severe disability, 5: severe disability and 6: death) at 7 days in the group with possible non-convulsive status epilepticus WITH hypermetabolism/hyperperfusion versus the group with possible non-convulsive status epilepticus WITHOUT hypermetabolism/hyperperfusion</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Functional imaging in possible non-convulsive status epilepticus and OUTCOME</measure>
      <time_frame>Day 30</time_frame>
      <description>The investigators will compare modified rankin scale (mRS) (0: no symptoms, 1: no significant disability, 2: slight disability, 3: moderate disability, 4: moderately severe disability, 5: severe disability and 6: death) at 30 days in the group with possible non-convulsive status epilepticus WITH hypermetabolism/hyperperfusion versus the group with possible non-convulsive status epilepticus WITHOUT hypermetabolism/hyperperfusion</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">200</enrollment>
    <condition>Status Epilepticus</condition>
    <condition>Ictal-interictal Continuum</condition>
    <condition>Positron-emission Tomography</condition>
    <condition>Perfusion Weighted MRI</condition>
    <condition>Perfusion CT</condition>
    <arm_group>
      <arm_group_label>Possible non-convulsive status epilepticus with ictal-interictal continuum EEG patterns</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>Patients with a possible non-convulsive status epilepticus, according to American Clinical Neurophysiology Criteria (ACNS) (2021).</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Healthy control subjects</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>Healthy control subjects.</description>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>MRI scan including arterial spin labelling of the brain</intervention_name>
      <description>Arterial Spin Labelling sequence, T2-weighted FLAIR images and T1-weighted images and diffusion weighted imaging sequence will be recorded</description>
      <arm_group_label>Healthy control subjects</arm_group_label>
      <arm_group_label>Possible non-convulsive status epilepticus with ictal-interictal continuum EEG patterns</arm_group_label>
      <other_name>Brain perfusion</other_name>
    </intervention>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>CT perfusion scan of the brain</intervention_name>
      <description>Siemens Naeotom Alpha with quantum technology (photon-counting)</description>
      <arm_group_label>Healthy control subjects</arm_group_label>
      <arm_group_label>Possible non-convulsive status epilepticus with ictal-interictal continuum EEG patterns</arm_group_label>
      <other_name>Brain perfusion</other_name>
    </intervention>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>FDG-PET scan of the brain</intervention_name>
      <description>An FDG-PET scan will be acquired on a GE Signa 3T PET-MR scanner. FDG-PET images will be assessed for focal hypermetabolism, including semiquantitative analysis of the maximal standard uptake value (SUVmax) relative to the SUVmax of the pons (SUVr pons)</description>
      <arm_group_label>Healthy control subjects</arm_group_label>
      <arm_group_label>Possible non-convulsive status epilepticus with ictal-interictal continuum EEG patterns</arm_group_label>
      <other_name>Brain metabolism</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          - The patient has possible non-convulsive status epilepticus with scalp or invasive EEG&#xD;
          with ictal-interictal continuum patterns on EEG&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  The patient has a contra-indication for MRI such as metal implants&#xD;
  &#xD;
            -  The patient has contrast sensitivity&#xD;
  &#xD;
            -  The patiensuffers from claustrophobia or cannot tolerate confinement during PET-MRI&#xD;
               scanning procedures&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>16 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Wim Van Paesschen, MD PhD</last_name>
      <phone>+3216344332</phone>
      <email>Wim.vanpaesschen@kuleuven.be</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Jeroen Gijs, MD</last_name>
      <phone>+3216344280</phone>
      <email>Jeroen.gijs@uzleuven.be</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>University Hospitals Leuven, department of Neurology</name>
        <address>
          <city>Leuven</city>
          <zip>3000</zip>
          <country>Belgium</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Belgium</country>
    </location_countries>
    <reference>
      <citation>Trinka E, Cock H, Hesdorffer D, Rossetti AO, Scheffer IE, Shinnar S, Shorvon S, Lowenstein DH. A definition and classification of status epilepticus--Report of the ILAE Task Force on Classification of Status Epilepticus. Epilepsia. 2015 Oct;56(10):1515-23. doi: 10.1111/epi.13121. Epub 2015 Sep 4.</citation>
      <PMID>26336950</PMID>
    </reference>
    <reference>
      <citation>Hirsch LJ, Fong MWK, Leitinger M, LaRoche SM, Beniczky S, Abend NS, Lee JW, Wusthoff CJ, Hahn CD, Westover MB, Gerard EE, Herman ST, Haider HA, Osman G, Rodriguez-Ruiz A, Maciel CB, Gilmore EJ, Fernandez A, Rosenthal ES, Claassen J, Husain AM, Yoo JY, So EL, Kaplan PW, Nuwer MR, van Putten M, Sutter R, Drislane FW, Trinka E, Gaspard N. American Clinical Neurophysiology Society's Standardized Critical Care EEG Terminology: 2021 Version. J Clin Neurophysiol. 2021 Jan 1;38(1):1-29. doi: 10.1097/WNP.0000000000000806. No abstract available.</citation>
      <PMID>33475321</PMID>
    </reference>
    <reference>
      <citation>Cormier J, Maciel CB, Gilmore EJ. Ictal-Interictal Continuum: When to Worry About the Continuous Electroencephalography Pattern. Semin Respir Crit Care Med. 2017 Dec;38(6):793-806. doi: 10.1055/s-0037-1607987. Epub 2017 Dec 20.</citation>
      <PMID>29262437</PMID>
    </reference>
    <reference>
      <citation>Rubinos C, Reynolds AS, Claassen J. The Ictal-Interictal Continuum: To Treat or Not to Treat (and How)? Neurocrit Care. 2018 Aug;29(1):3-8. doi: 10.1007/s12028-017-0477-5.</citation>
      <PMID>29139014</PMID>
    </reference>
    <reference>
      <citation>Osman GM, Araujo DF, Maciel CB. Ictal Interictal Continuum Patterns. Curr Treat Options Neurol. 2018 Apr 18;20(5):15. doi: 10.1007/s11940-018-0500-y.</citation>
      <PMID>29666958</PMID>
    </reference>
    <reference>
      <citation>Rodriguez Ruiz A, Vlachy J, Lee JW, Gilmore EJ, Ayer T, Haider HA, Gaspard N, Ehrenberg JA, Tolchin B, Fantaneanu TA, Fernandez A, Hirsch LJ, LaRoche S; Critical Care EEG Monitoring Research Consortium. Association of Periodic and Rhythmic Electroencephalographic Patterns With Seizures in Critically Ill Patients. JAMA Neurol. 2017 Feb 1;74(2):181-188. doi: 10.1001/jamaneurol.2016.4990.</citation>
      <PMID>27992625</PMID>
    </reference>
    <reference>
      <citation>Struck AF, Westover MB, Hall LT, Deck GM, Cole AJ, Rosenthal ES. Metabolic Correlates of the Ictal-Interictal Continuum: FDG-PET During Continuous EEG. Neurocrit Care. 2016 Jun;24(3):324-31. doi: 10.1007/s12028-016-0245-y.</citation>
      <PMID>27169855</PMID>
    </reference>
    <reference>
      <citation>Subramaniam T, Jain A, Hall LT, Cole AJ, Westover MB, Rosenthal ES, Struck AF. Lateralized periodic discharges frequency correlates with glucose metabolism. Neurology. 2019 Feb 12;92(7):e670-e674. doi: 10.1212/WNL.0000000000006903. Epub 2019 Jan 11.</citation>
      <PMID>30635488</PMID>
    </reference>
    <reference>
      <citation>Venkatraman A, Khawaja A, Bag AK, Mirza M, Szaflarski JP, Pati SBB. Perfusion MRI Can Impact Treatment Decision in Ictal-Interictal Continuum. J Clin Neurophysiol. 2017 Jul;34(4):e15-e18. doi: 10.1097/WNP.0000000000000350.</citation>
      <PMID>27749504</PMID>
    </reference>
    <reference>
      <citation>Gugger JJ, Llinas RH, Kaplan PW. The role of CT perfusion in the evaluation of seizures, the post-ictal state, and status epilepticus. Epilepsy Res. 2020 Jan;159:106256. doi: 10.1016/j.eplepsyres.2019.106256. Epub 2019 Dec 12.</citation>
      <PMID>31862478</PMID>
    </reference>
    <reference>
      <citation>Trinka E, Leitinger M. Management of Status Epilepticus, Refractory Status Epilepticus, and Super-refractory Status Epilepticus. Continuum (Minneap Minn). 2022 Apr 1;28(2):559-602. doi: 10.1212/CON.0000000000001103.</citation>
      <PMID>35393970</PMID>
    </reference>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 11, 2023</study_first_submitted>
    <study_first_submitted_qc>August 24, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 30, 2023</study_first_posted>
    <last_update_submitted>August 24, 2023</last_update_submitted>
    <last_update_submitted_qc>August 24, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 30, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>possible non-convulsive status epilepticus</keyword>
    <keyword>ictal-interictal continuum</keyword>
    <keyword>EEG</keyword>
    <keyword>MRI</keyword>
    <keyword>FDG-PET</keyword>
    <keyword>CT perfusion</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Status Epilepticus</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>Our original imaging and annotated EEG data will be made available to researchers who provide a methodologically sound proposal.</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
      <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
      <ipd_info_type>Analytic Code</ipd_info_type>
      <ipd_time_frame>data will be made available after publication of our results. There is no end date.</ipd_time_frame>
      <ipd_access_criteria>Proposals should be directed to Jeroen.gijs@uzleuven.be. To gain access, data requestors will need to sign a data access agreement.</ipd_access_criteria>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06017973
  org study id: S67933
  nct id: NCT06017973
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The investigators propose a prospective study of 20 control subjects and 180 consecutive
        patients with possible non-convulsive status epilepticus (NCSE). The investigators will
        obtain three functional images of the brain:
  
          1. Fluorodeoxyglucose positron emission tomography (FDG-PET)
  
          2. Perfusion (and structural) magnetic resonance (MR) images
  
          3. Computed tomography (CT) perfusion.
  
        Brain hypermetabolism/hyperperfusion is a strong argument to confirm a diagnosis of
        non-convulsive status epilepticus.
  
        The aim is to determine which of the three functional imaging techniques is the most
        sensitive and easy to obtain in the detection of hypermetabolism/hyperperfusion. The
        investigators will determine which EEG patterns are associated with
        hypermetabolism/perfusion.
  
        The investigators will further study and describe the management with antiseizure medication
        and outcome of the group with possible non-convulsive status epilepticus WITH
        hypermetabolism/hyperperfusion versus the group with possible non-convulsive status
        epilpticus WITHOUT hypermetabolism/hyperperfusion.
  
        The investigators will make recommendations for an imaging protocol in possible NCSE for
        widespread use. The aim is to offer guidelines to incorporate imaging in the diagnosis,
        management and prognosis of NCSE in patients with the ictal-interictal continuum.
  allocation: Non-Randomized
  intervention model: Parallel Assignment
  primary purpose: Diagnostic
  masking: None (Open Label)
  measure: Sensitivity of MRI arterial spin labelling, CT perfusion and FDG-PET of the brain to detect hyperperfusion/hypermetabolism in possible non-convulsive status epilepticus
  time frame: Day 1
  description: The investigators will determine which diagnostic test (MRI, CT or FDG-PET) is most sensitive in detecting hyperperfusion/hypermetabolism in possible non-convulsive status epilepticus to confirm a diagnosis of non-convulsive status epilepticus
  measure: Correlation between FREQUENCY of ictal-interictal EEG patterns within 30 minutes after FDG-PET injection and standardised uptake value on FDG-PET.
  time frame: Day 1
  description: The investigators will assess the correlation between standardised uptake value of the cerebral hypermetabolic region and the frequency of ictal-interictal EEG patterns within 30 minutes after injection of FDG. The frequency of ictal-interictal EEG patterns will be scored semi-quantitatively based on the American Clinical Neurophysiology Criteria (ACNS) criteria (2021).
  measure: Correlation between PREVALENCE of ictal-interictal EEG patterns on EEG within 30 minutes after FDG-PET injection and standardised uptake value on FDG-PET.
  time frame: Day 1
  description: The investigators will assess the correlation between standardised uptake value of the cerebral hypermetabolic region and the prevalence of ictal-interictal EEG patterns within 30 minutes after injection of FDG. The prevalence of ictal-interictal EEG patterns will be scored semi-quantitatively based on the American Clinical Neurophysiology Criteria (ACNS) (2021)
  measure: The seizure freedom of patients with hypermetabolism compared to those with hypometabolism within 24 hours after undergoing an FDG-PET scan.
  time frame: Day 1
  description: The investigators will assess the seizure freedom of patients in the hypermetabolic vs hypometabolic group. Patients will receive video EEG-monitoring for 24 hours after FDG-PET. Seizures will be defined according to current American Clinical Neurophysiology Criteria (ACNS) (2021) based on electrographic and clinical data. Hypermetabolism/hypometabolism will be qualitatively scored by a trained nuclearist.
  measure: Correlation between SHARPNESS of ictal-interictal EEG patterns on EEG within 30 minutes after FDG-PET injection and standardised uptake value on FDG-PET.
  time frame: Day 1
  description: The investigators will assess the correlation between standardised uptake value of the cerebral hypermetabolic region and the sharpness of ictal-interictal EEG patterns within 30 minutes after injection of FDG. The sharpness of ictal-interictal EEG patterns will be scored semi-quantitatively based on the American Clinical Neurophysiology Criteria (ACNS) (2021)
  measure: Correlation between AMPLITUDE of ictal-interictal EEG patterns within 30 minutes after FDG-PET injection and standardised uptake value on FDG-PET
  time frame: Day 1
  description: The investigators will assess the correlation between standardised uptake value of the cerebral hypermetabolic region and the amplitude of ictal-interictal EEG patterns within 30 minutes after injection of FDG. The amplitude of ictal-interictal EEG patterns will be scored semi-quantitatively based on the American Clinical Neurophysiology Criteria (ACNS) (2021)
  measure: Correlation between EVOLUTION of ictal-interictal EEG patterns on EEG within 30 minutes after FDG-PET injection and standardised uptake value on FDG-PET.
  time frame: Day 1
  description: The investigators will assess the correlation between standardised uptake value of the cerebral hypermetabolic region and evolution of ictal-interictal EEG patterns within 30 minutes after injection of FDG (i.e. static, fluctuating or evolving). The presence of fluctuation and evolution of ictal-interictal EEG patterns will be scored based on the American Clinical Neurophysiology Criteria (ACNS) (2021)
  measure: Functional imaging in possible non-convulsive status epilepticus and INTERICTAL BURDEN
  time frame: Day 7
  description: The investigators will compare interictal burden, defined as a percentage of ictal-interictal EEG patterns during continuous EEG monitoring, in the group with possible non-convulsive status epilepticus WITH hypermetabolism/hyperperfusion versus the group with possible non-convulsive status epilepticus WITHOUT hypermetabolism/hyperperfusion
  measure: Functional imaging in possible non-convulsive status epilepticus and ANTISEIZURE MEDICATION (ASM)
  time frame: Day 30
  description: The investigators will document all changes in antiseizure medication and compare these in the group with possible non-convulsive status epilepticus WITH hypermetabolism/hyperperfusion versus the group with possible non-convulsive status epilepticus WITHOUT hypermetabolism/hyperperfusion
  measure: Functional imaging in possible non-convulsive status epilepticus and OUTCOME
  time frame: Day 7
  description: The investigators will compare modified rankin scale (mRS) (0: no symptoms, 1: no significant disability, 2: slight disability, 3: moderate disability, 4: moderately severe disability, 5: severe disability and 6: death) at 7 days in the group with possible non-convulsive status epilepticus WITH hypermetabolism/hyperperfusion versus the group with possible non-convulsive status epilepticus WITHOUT hypermetabolism/hyperperfusion
  measure: Functional imaging in possible non-convulsive status epilepticus and OUTCOME
  time frame: Day 30
  description: The investigators will compare modified rankin scale (mRS) (0: no symptoms, 1: no significant disability, 2: slight disability, 3: moderate disability, 4: moderately severe disability, 5: severe disability and 6: death) at 30 days in the group with possible non-convulsive status epilepticus WITH hypermetabolism/hyperperfusion versus the group with possible non-convulsive status epilepticus WITHOUT hypermetabolism/hyperperfusion
  arm group label: Possible non-convulsive status epilepticus with ictal-interictal continuum EEG patterns
  arm group type: Other
  description: Patients with a possible non-convulsive status epilepticus, according to American Clinical Neurophysiology Criteria (ACNS) (2021).
  arm group label: Healthy control subjects
  arm group type: Other
  description: Healthy control subjects.
  intervention type: Diagnostic Test
  intervention name: MRI scan including arterial spin labelling of the brain
  description: Arterial Spin Labelling sequence, T2-weighted FLAIR images and T1-weighted images and diffusion weighted imaging sequence will be recorded
  arm group label: Healthy control subjects
  arm group label: Possible non-convulsive status epilepticus with ictal-interictal continuum EEG patterns
  other name: Brain perfusion
  intervention type: Diagnostic Test
  intervention name: CT perfusion scan of the brain
  description: Siemens Naeotom Alpha with quantum technology (photon-counting)
  arm group label: Healthy control subjects
  arm group label: Possible non-convulsive status epilepticus with ictal-interictal continuum EEG patterns
  other name: Brain perfusion
  intervention type: Diagnostic Test
  intervention name: FDG-PET scan of the brain
  description: An FDG-PET scan will be acquired on a GE Signa 3T PET-MR scanner. FDG-PET images will be assessed for focal hypermetabolism, including semiquantitative analysis of the maximal standard uptake value (SUVmax) relative to the SUVmax of the pons (SUVr pons)
  arm group label: Healthy control subjects
  arm group label: Possible non-convulsive status epilepticus with ictal-interictal continuum EEG patterns
  other name: Brain metabolism
  criteria: 
  gender: All
  minimum age: 16 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Wim Van Paesschen, MD PhD
  phone: +3216344332
  email: Wim.vanpaesschen@kuleuven.be
  last name: Jeroen Gijs, MD
  phone: +3216344280
  email: Jeroen.gijs@uzleuven.be
  facility: 
  country: Belgium
  citation: Trinka E, Cock H, Hesdorffer D, Rossetti AO, Scheffer IE, Shinnar S, Shorvon S, Lowenstein DH. A definition and classification of status epilepticus--Report of the ILAE Task Force on Classification of Status Epilepticus. Epilepsia. 2015 Oct;56(10):1515-23. doi: 10.1111/epi.13121. Epub 2015 Sep 4.
  PMID: 26336950
  citation: Hirsch LJ, Fong MWK, Leitinger M, LaRoche SM, Beniczky S, Abend NS, Lee JW, Wusthoff CJ, Hahn CD, Westover MB, Gerard EE, Herman ST, Haider HA, Osman G, Rodriguez-Ruiz A, Maciel CB, Gilmore EJ, Fernandez A, Rosenthal ES, Claassen J, Husain AM, Yoo JY, So EL, Kaplan PW, Nuwer MR, van Putten M, Sutter R, Drislane FW, Trinka E, Gaspard N. American Clinical Neurophysiology Society's Standardized Critical Care EEG Terminology: 2021 Version. J Clin Neurophysiol. 2021 Jan 1;38(1):1-29. doi: 10.1097/WNP.0000000000000806. No abstract available.
  PMID: 33475321
  citation: Cormier J, Maciel CB, Gilmore EJ. Ictal-Interictal Continuum: When to Worry About the Continuous Electroencephalography Pattern. Semin Respir Crit Care Med. 2017 Dec;38(6):793-806. doi: 10.1055/s-0037-1607987. Epub 2017 Dec 20.
  PMID: 29262437
  citation: Rubinos C, Reynolds AS, Claassen J. The Ictal-Interictal Continuum: To Treat or Not to Treat (and How)? Neurocrit Care. 2018 Aug;29(1):3-8. doi: 10.1007/s12028-017-0477-5.
  PMID: 29139014
  citation: Osman GM, Araujo DF, Maciel CB. Ictal Interictal Continuum Patterns. Curr Treat Options Neurol. 2018 Apr 18;20(5):15. doi: 10.1007/s11940-018-0500-y.
  PMID: 29666958
  citation: Rodriguez Ruiz A, Vlachy J, Lee JW, Gilmore EJ, Ayer T, Haider HA, Gaspard N, Ehrenberg JA, Tolchin B, Fantaneanu TA, Fernandez A, Hirsch LJ, LaRoche S; Critical Care EEG Monitoring Research Consortium. Association of Periodic and Rhythmic Electroencephalographic Patterns With Seizures in Critically Ill Patients. JAMA Neurol. 2017 Feb 1;74(2):181-188. doi: 10.1001/jamaneurol.2016.4990.
  PMID: 27992625
  citation: Struck AF, Westover MB, Hall LT, Deck GM, Cole AJ, Rosenthal ES. Metabolic Correlates of the Ictal-Interictal Continuum: FDG-PET During Continuous EEG. Neurocrit Care. 2016 Jun;24(3):324-31. doi: 10.1007/s12028-016-0245-y.
  PMID: 27169855
  citation: Subramaniam T, Jain A, Hall LT, Cole AJ, Westover MB, Rosenthal ES, Struck AF. Lateralized periodic discharges frequency correlates with glucose metabolism. Neurology. 2019 Feb 12;92(7):e670-e674. doi: 10.1212/WNL.0000000000006903. Epub 2019 Jan 11.
  PMID: 30635488
  citation: Venkatraman A, Khawaja A, Bag AK, Mirza M, Szaflarski JP, Pati SBB. Perfusion MRI Can Impact Treatment Decision in Ictal-Interictal Continuum. J Clin Neurophysiol. 2017 Jul;34(4):e15-e18. doi: 10.1097/WNP.0000000000000350.
  PMID: 27749504
  citation: Gugger JJ, Llinas RH, Kaplan PW. The role of CT perfusion in the evaluation of seizures, the post-ictal state, and status epilepticus. Epilepsy Res. 2020 Jan;159:106256. doi: 10.1016/j.eplepsyres.2019.106256. Epub 2019 Dec 12.
  PMID: 31862478
  citation: Trinka E, Leitinger M. Management of Status Epilepticus, Refractory Status Epilepticus, and Super-refractory Status Epilepticus. Continuum (Minneap Minn). 2022 Apr 1;28(2):559-602. doi: 10.1212/CON.0000000000001103.
  PMID: 35393970
  responsible party type: Sponsor
  mesh term: Status Epilepticus
  sharing ipd: Yes
  ipd description: Our original imaging and annotated EEG data will be made available to researchers who provide a methodologically sound proposal.
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd info type: Informed Consent Form (ICF)
  ipd info type: Clinical Study Report (CSR)
  ipd info type: Analytic Code
  ipd time frame: data will be made available after publication of our results. There is no end date.
  ipd access criteria: Proposals should be directed to Jeroen.gijs@uzleuven.be. To gain access, data requestors will need to sign a data access agreement.