<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/NCT04412434</url>
  </required_header>
  <id_info>
    <org_study_id>0297-20 RMB</org_study_id>
    <nct_id>NCT04412434</nct_id>
  </id_info>
  <brief_title>EEG Patterns in Patients With Acute Ischemic Stroke Resulted From Large Vessels Occlusion in the Anterior Circulation</brief_title>
  <official_title>EEG Patterns in Patients With Acute Ischemic Stroke Resulted From Large Vessels Occlusion in the Anterior Circulation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>rambam62</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Rambam Health Care Campus</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Clinical deterioration is observing in up to forty percent of patients with acute ischemic&#xD;
      stroke (AIS) due to large vessels occlusion. Until now, there is no automated monitoring&#xD;
      system for early detection of neurological deterioration in such patients. As a first step to&#xD;
      develop such system investigators suggest this study aiming to evaluate patterns of brain&#xD;
      electrical activity registered by EEG in patients with AIS attributed to the MCA or ICA&#xD;
      territory correlated with location and extension of ischemic lesions as determined by&#xD;
      non-contrast CT (NCT).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Rationale. Despite the exciting developments in the treatment of acute ischemic stroke (AIS)&#xD;
      in last years, the problem of neurological deterioration in patients with AIS remains&#xD;
      unresolved and poorly understandable. This is especially correct about patients with AIS&#xD;
      resulted from large vessel occlusion (LVO), mainly internal carotid artery (ICA) and middle&#xD;
      cerebral artery (MCA) occlusion. Such deterioration is observing in up to forty percent of&#xD;
      patients with acute ischemic stroke due to LVO. On the other side, according to the&#xD;
      literature about 40 % of LVO strokes resulted from atrial fibrillation. Until now, there is&#xD;
      no automated monitoring system for early detection of neurological deterioration in AIS&#xD;
      patients. Such monitoring system may save millions of lives of stroke victims all over the&#xD;
      world. As a first step to develop such system based on change of brain electrical activity&#xD;
      registered by electroencephalography (EEG) in patients with AIS investigators suggest this&#xD;
      study.&#xD;
&#xD;
      Overall goal. The aim of the suggested research is to evaluate patterns of brain electrical&#xD;
      activity registered by EEG in patients with AIS attributed to the MCA or ICA territory in&#xD;
      correlation with location and extension of ischemic lesions as determined by non-contrast CT&#xD;
      (NCT). Based on these data, the attempt to find algorithms, describing such correlation will&#xD;
      be done.&#xD;
&#xD;
      Target population. The prospective study will include at least 200 AIS patients with acute&#xD;
      stroke resulted from MCA or ICA occlusion.&#xD;
&#xD;
      Methods. Non contrast CT and EEG will be done at the same day. Neurologist will evaluate&#xD;
      neurological status at the day of EEG and CT performing and clinical score by National&#xD;
      Institute of Health Stroke Scale (NIHSS) will be obtained. EEG will be performed continuously&#xD;
      for at least 30 minutes with 19-channel EEG machine.&#xD;
&#xD;
      Assessment. After gathering clinical, EEG and NCT data mathematical and computerized analysis&#xD;
      (including Artificial Intelligence methods) will be applied aiming to find algorithms&#xD;
      describing relationship between size and location of AIS and change in brain electrical&#xD;
      activity registered by EEG in AIS patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">October 4, 2020</start_date>
  <completion_date type="Anticipated">July 2022</completion_date>
  <primary_completion_date type="Anticipated">July 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>EEG pattern</measure>
    <time_frame>24 months</time_frame>
    <description>EEG patterns depending on size and location of acute ischemic stroke,including generalized or focal slowing or both and epileptiform discharges</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Stroke, Ischemic</condition>
  <arm_group>
    <arm_group_label>patients with acute ischemic stroke</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>This open-label prospective study will be conducted in the single medical center (RAMBAM Medical Center) and will include at least 200 patients with acute ischemic stroke resulted from MCA or ICA occlusion.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Electroencephalography (EEG)</intervention_name>
    <description>Electroencephalography (EEG) is a painless and harmless method to record the bioelectric activity of the brain. Clinically, EEG refers to the recording of the brain's spontaneous electrical activity over a period of time, as recorded from multiple electrodes placed on the scalp This method can be helpful in the diagnosis of many various brain diseases and pathological conditions.&#xD;
For the examination, electrodes are placed on the head, using a special harmless gel, similar to gel, used in ultrasonographic studies.</description>
    <arm_group_label>patients with acute ischemic stroke</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with acute ischemic stroke, due to large vessel occlusion&#xD;
&#xD;
          -  Age of 18 years and more&#xD;
&#xD;
          -  Male or Female&#xD;
&#xD;
          -  Modified Rankin Scale of ≤ 2 prior to presentation&#xD;
&#xD;
          -  NIHSS ≥ 4 at the day of NCT and EEG&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Epilepsy&#xD;
&#xD;
          -  Brainstem or cerebellar stroke&#xD;
&#xD;
          -  Intracranial or extracranial hemorrhage of any kind&#xD;
&#xD;
          -  History of severe head trauma&#xD;
&#xD;
          -  History of severe dementia or progressive neurodegenerative disease&#xD;
&#xD;
          -  Cerebral tumor or hydrocephalus by anamnesis or by imaging&#xD;
&#xD;
          -  Lacunar stroke&#xD;
&#xD;
          -  Significant movement disorder.&#xD;
&#xD;
          -  Local skull or skin condition, preventing EEG electrode application.&#xD;
&#xD;
          -  Any known disorder, which may interfere with the protocol implementation.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gregory Telman, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Rambam Health Care Campus</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Gregory Telman, MD</last_name>
    <phone>972-47772161</phone>
    <email>g_telman@rmc.gov.il</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Svetlana Afanasiev, MPH</last_name>
    <phone>972-47771926</phone>
    <email>s_afanasiev@rmc.gov.il</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Rambam MC</name>
      <address>
        <city>Haifa</city>
        <country>Israel</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Gregory Telman, MD</last_name>
      <phone>97247772161</phone>
      <email>g_telman@rmc.gov.il</email>
    </contact>
    <contact_backup>
      <last_name>Svetlana Afanasiev, MPH</last_name>
      <phone>972-47771926</phone>
      <email>s_afanasiev@rmc.gov.il</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>May 27, 2020</study_first_submitted>
  <study_first_submitted_qc>June 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 2, 2020</study_first_posted>
  <last_update_submitted>March 9, 2021</last_update_submitted>
  <last_update_submitted_qc>March 9, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 12, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Rambam Health Care Campus</investigator_affiliation>
    <investigator_full_name>rambam62</investigator_full_name>
    <investigator_title>Director, Head of Stroke Service, Principal Investigator, Clinical Professor</investigator_title>
  </responsible_party>
  <keyword>eeg pattern</keyword>
  <keyword>acute ischemic stroke</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</mesh_term>
    <mesh_term>Ischemic Stroke</mesh_term>
    <mesh_term>Ischemia</mesh_term>
  </condition_browse>
  <!-- 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/NCT04412434
org study id: 0297-20 RMB
nct id: NCT04412434
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
Clinical deterioration is observing in up to forty percent of patients with acute ischemic
      stroke (AIS) due to large vessels occlusion. Until now, there is no automated monitoring
      system for early detection of neurological deterioration in such patients. As a first step to
      develop such system investigators suggest this study aiming to evaluate patterns of brain
      electrical activity registered by EEG in patients with AIS attributed to the MCA or ICA
      territory correlated with location and extension of ischemic lesions as determined by
      non-contrast CT (NCT).
Rationale. Despite the exciting developments in the treatment of acute ischemic stroke (AIS)
      in last years, the problem of neurological deterioration in patients with AIS remains
      unresolved and poorly understandable. This is especially correct about patients with AIS
      resulted from large vessel occlusion (LVO), mainly internal carotid artery (ICA) and middle
      cerebral artery (MCA) occlusion. Such deterioration is observing in up to forty percent of
      patients with acute ischemic stroke due to LVO. On the other side, according to the
      literature about 40 % of LVO strokes resulted from atrial fibrillation. Until now, there is
      no automated monitoring system for early detection of neurological deterioration in AIS
      patients. Such monitoring system may save millions of lives of stroke victims all over the
      world. As a first step to develop such system based on change of brain electrical activity
      registered by electroencephalography (EEG) in patients with AIS investigators suggest this
      study.

      Overall goal. The aim of the suggested research is to evaluate patterns of brain electrical
      activity registered by EEG in patients with AIS attributed to the MCA or ICA territory in
      correlation with location and extension of ischemic lesions as determined by non-contrast CT
      (NCT). Based on these data, the attempt to find algorithms, describing such correlation will
      be done.

      Target population. The prospective study will include at least 200 AIS patients with acute
      stroke resulted from MCA or ICA occlusion.

      Methods. Non contrast CT and EEG will be done at the same day. Neurologist will evaluate
      neurological status at the day of EEG and CT performing and clinical score by National
      Institute of Health Stroke Scale (NIHSS) will be obtained. EEG will be performed continuously
      for at least 30 minutes with 19-channel EEG machine.

      Assessment. After gathering clinical, EEG and NCT data mathematical and computerized analysis
      (including Artificial Intelligence methods) will be applied aiming to find algorithms
      describing relationship between size and location of AIS and change in brain electrical
      activity registered by EEG in AIS patients.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: EEG pattern
time frame: 24 months
description: EEG patterns depending on size and location of acute ischemic stroke,including generalized or focal slowing or both and epileptiform discharges
arm group label: patients with acute ischemic stroke
arm group type: Other
description: This open-label prospective study will be conducted in the single medical center (RAMBAM Medical Center) and will include at least 200 patients with acute ischemic stroke resulted from MCA or ICA occlusion.
intervention type: Diagnostic Test
intervention name: Electroencephalography (EEG)
description: Electroencephalography (EEG) is a painless and harmless method to record the bioelectric activity of the brain. Clinically, EEG refers to the recording of the brain's spontaneous electrical activity over a period of time, as recorded from multiple electrodes placed on the scalp This method can be helpful in the diagnosis of many various brain diseases and pathological conditions.
For the examination, electrodes are placed on the head, using a special harmless gel, similar to gel, used in ultrasonographic studies.
arm group label: patients with acute ischemic stroke
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Gregory Telman, MD
role: Principal Investigator
affiliation: Rambam Health Care Campus
last name: Gregory Telman, MD
phone: 972-47772161
email: g_telman@rmc.gov.il
last name: Svetlana Afanasiev, MPH
phone: 972-47771926
email: s_afanasiev@rmc.gov.il
facility: 
status: Recruiting
contact: 
contact backup: 
country: Israel
responsible party type: Sponsor-Investigator
investigator affiliation: Rambam Health Care Campus
investigator full name: rambam62
investigator title: Director, Head of Stroke Service, Principal Investigator, Clinical Professor
mesh term: Stroke
mesh term: Ischemic Stroke
mesh term: Ischemia