<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/NCT02995447</url>
  </required_header>
  <id_info>
    <org_study_id>EPI_12</org_study_id>
    <nct_id>NCT02995447</nct_id>
  </id_info>
  <brief_title>Differential Effects of Propofol on Scalp and Intracranial EEG</brief_title>
  <official_title>Differential Effects of Propofol on Scalp and Intracranial Electroencephalogram</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Bonn</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Bonn</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The anesthetic propofol has a dose-depending effect on the EEG, which differs in comparison&#xD;
      between scalp and intracerebral electrodes&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The electrical activity of the brain (electroencephalogram EEG) is usually assessed from the&#xD;
      surface of the head, which is approximately 1-2 cm above the cerebral cortex. Thus, the&#xD;
      spatial resolution of the EEG is low, and the electrical activity recorded originates from a&#xD;
      multitude of neurons.&#xD;
&#xD;
      Deep brain structures such as the hippocampus also generate electrical activity which cannot&#xD;
      be assessed from the surface of the head. However, in some patients electrodes are implanted&#xD;
      into the brain to look for the origin of epileptic seizures. Along the way, these&#xD;
      intracerebral electrodes enable to record the EEG from intracerebral structures which are&#xD;
      generated from few neurons only. Once the origin of epilepsy has been identified, the&#xD;
      intracerebral electrodes are removed under general anesthesia.&#xD;
&#xD;
      Anesthetics such as propofol characteristically modify the EEG in a dose-dependant manner.&#xD;
      More over, the propofol effect on the EEG recorded from the surface is likely to be different&#xD;
      from the intracerebral EEG, however little is known so far. Therefore we aim to investigate&#xD;
      the differential effect of propofol on the superficial versus intracerebral recorded EEG.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>November 2012</start_date>
  <completion_date type="Anticipated">December 2018</completion_date>
  <primary_completion_date type="Anticipated">October 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>EEG amplitude</measure>
    <time_frame>up to two hours of EEG recording</time_frame>
    <description>EEG amplitude in comparison between scalp and intracranial recordings</description>
  </primary_outcome>
  <primary_outcome>
    <measure>EEG frequency spectrum</measure>
    <time_frame>up to two hours of EEG recording</time_frame>
    <description>EEG frequency spectrum in comparison between scalp and intracranial recordings</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>EEG Burst Suppression Ratio</measure>
    <time_frame>up to two hours of EEG recording</time_frame>
    <description>EEG Burst Suppression Ratio in comparison between scalp and intracranial recordings</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">15</enrollment>
  <condition>General Anesthesia</condition>
  <arm_group>
    <arm_group_label>epilepsy patients</arm_group_label>
    <description>The group consists of patients with therapy refractory epilepsy, in which intracerebral electrodes were implanted to locate the seizure origin and to determine whether the patients are eligible for epilepsy surgery. In an observational study, differences between surface and intracerebral EEG are recorded.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>differences between surface and intracerebral EEG</intervention_name>
    <description>No intervention is performed. Im- and explantation of intracerebral electrodes is performed for clinical and not for study purposes. The only difference between study and non-study patients is that the surface as well as the intracerebral EEG is recorded and stored in the former, while it is discarded in the latter.</description>
    <arm_group_label>epilepsy patients</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients suffering from epilepsy&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with implanted intracerebral EEG electrodes&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy&#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>Martin Soehle, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Dept. of Anesthesiology and Intensive Care Medicine</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Martin Soehle, MD, PhD</last_name>
    <phone>++49-228-287-</phone>
    <phone_ext>11378</phone_ext>
    <email>martin.soehle@ukb.uni-bonn.de</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Florian Mormann, MD, PhD</last_name>
    <phone>++49-228-287-</phone>
    <phone_ext>15738</phone_ext>
    <email>Florian.Mormann@ukb.uni-bonn.de</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Dept. of Anaesthesiology and Intensive Care Medicine, University of Bonn</name>
      <address>
        <city>Bonn</city>
        <zip>53105</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Martin Soehle, MD, PhD</last_name>
      <email>martin.soehle@ukb.uni-bonn.de</email>
    </contact>
    <contact_backup>
      <last_name>Florian Mormann, MD, PhD</last_name>
      <email>Florian.Mormann@ukb.uni-bonn.de</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>December 2017</verification_date>
  <study_first_submitted>October 3, 2014</study_first_submitted>
  <study_first_submitted_qc>December 13, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 16, 2016</study_first_posted>
  <last_update_submitted>December 4, 2017</last_update_submitted>
  <last_update_submitted_qc>December 4, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">December 5, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Hospital, Bonn</investigator_affiliation>
    <investigator_full_name>Martin Soehle</investigator_full_name>
    <investigator_title>Consultant</investigator_title>
  </responsible_party>
  <keyword>propofol</keyword>
  <keyword>electroencephalogram</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT02995447
org study id: EPI_12
nct id: NCT02995447
lead sponsor: 
has dmc: No
The anesthetic propofol has a dose-depending effect on the EEG, which differs in comparison
      between scalp and intracerebral electrodes
The electrical activity of the brain (electroencephalogram EEG) is usually assessed from the
      surface of the head, which is approximately 1-2 cm above the cerebral cortex. Thus, the
      spatial resolution of the EEG is low, and the electrical activity recorded originates from a
      multitude of neurons.

      Deep brain structures such as the hippocampus also generate electrical activity which cannot
      be assessed from the surface of the head. However, in some patients electrodes are implanted
      into the brain to look for the origin of epileptic seizures. Along the way, these
      intracerebral electrodes enable to record the EEG from intracerebral structures which are
      generated from few neurons only. Once the origin of epilepsy has been identified, the
      intracerebral electrodes are removed under general anesthesia.

      Anesthetics such as propofol characteristically modify the EEG in a dose-dependant manner.
      More over, the propofol effect on the EEG recorded from the surface is likely to be different
      from the intracerebral EEG, however little is known so far. Therefore we aim to investigate
      the differential effect of propofol on the superficial versus intracerebral recorded EEG.
observational model: Cohort
time perspective: Prospective
measure: EEG amplitude
time frame: up to two hours of EEG recording
description: EEG amplitude in comparison between scalp and intracranial recordings
measure: EEG frequency spectrum
time frame: up to two hours of EEG recording
description: EEG frequency spectrum in comparison between scalp and intracranial recordings
measure: EEG Burst Suppression Ratio
time frame: up to two hours of EEG recording
description: EEG Burst Suppression Ratio in comparison between scalp and intracranial recordings
arm group label: epilepsy patients
description: The group consists of patients with therapy refractory epilepsy, in which intracerebral electrodes were implanted to locate the seizure origin and to determine whether the patients are eligible for epilepsy surgery. In an observational study, differences between surface and intracerebral EEG are recorded.
intervention type: Other
intervention name: differences between surface and intracerebral EEG
description: No intervention is performed. Im- and explantation of intracerebral electrodes is performed for clinical and not for study purposes. The only difference between study and non-study patients is that the surface as well as the intracerebral EEG is recorded and stored in the former, while it is discarded in the latter.
arm group label: epilepsy patients
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Martin Soehle, MD, PhD
role: Principal Investigator
affiliation: Dept. of Anesthesiology and Intensive Care Medicine
last name: Martin Soehle, MD, PhD
phone: ++49-228-287-
phone ext: 11378
email: martin.soehle@ukb.uni-bonn.de
last name: Florian Mormann, MD, PhD
phone: ++49-228-287-
phone ext: 15738
email: Florian.Mormann@ukb.uni-bonn.de
facility: 
status: Recruiting
contact: 
contact backup: 
country: Germany
responsible party type: Principal Investigator
investigator affiliation: University Hospital, Bonn
investigator full name: Martin Soehle
investigator title: Consultant
sharing ipd: No