<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/NCT02976168</url>
  </required_header>
  <id_info>
    <org_study_id>IPCog</org_study_id>
    <nct_id>NCT02976168</nct_id>
  </id_info>
  <brief_title>Intracranial Pressure and Brain Function: Effects of Head Down Tilt Upon Brain Perfusion and Cognitive Performance</brief_title>
  <acronym>IPCog</acronym>
  <official_title>Intracranial Pressure and Brain Function: Effects of Head Down Tilt Upon Brain Perfusion and Cognitive Performance</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>DLR German Aerospace Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Forschungszentrum Juelich</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University Hospital, Umeå</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Cologne</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>DLR German Aerospace Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of the study is to understand the relationship between intracranial pressure&#xD;
      regulation, cerebral tissue oxygenation and cognitive functioning. More specifically, the&#xD;
      study tests the hypothesis that head down tilt will increase intracranial pressure (not&#xD;
      measured in this study, but demonstrated in previous studies), will induce venous congestion&#xD;
      and facial swelling, decrease intracranial tissue oxygenation and hamper brain functioning.&#xD;
      The objectives of the study therefore are to assess young healthy people during head-down&#xD;
      tilt (HDT), and to assess cognitive brain functioning, cerebral tissue oxygenation&#xD;
      (non-invasively), frontal skin thickness, cerebral perfusion and neuronal functioning via&#xD;
      event-related potentials.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>March 2016</start_date>
  <completion_date type="Actual">November 2016</completion_date>
  <primary_completion_date type="Actual">November 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in cognitive test battery score</measure>
    <time_frame>Twice at baseline, and 30 minutes and 20 hours after starting the intervention</time_frame>
    <description>The test battery includes sensomotoric speed, psychomotor vigilance, visual analysis of items, abstract thinking and mathematical processing</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in mid cerebral artery blood flow velocity</measure>
    <time_frame>Twice at baseline, and 10 minutes and 19 hours after starting the intervention</time_frame>
    <description>Transcranial Doppler measurements</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in cerebral tissue oxygenation</measure>
    <time_frame>Twice at baseline, and 10 minutes and 19 hours after starting the intervention</time_frame>
    <description>Near-infrared measurement</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Magnetic resonance Imaging: Change in cerebral blood flow</measure>
    <time_frame>Once at baseline, and 2 and 19 hours after starting the intervention</time_frame>
    <description>Magnetic resonance imaging will be performed in order to gain information about intracranial blood flow.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Magnetic resonance Imaging: Change in resting state functional MRI (fMRI)</measure>
    <time_frame>Once at baseline, and 2 and 19 hours after starting the intervention</time_frame>
    <description>Magnetic resonance imaging will be performed to assess resting state functional MRI.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Magnetic resonance Imaging: Change in fMRI Response to decision task</measure>
    <time_frame>Once at baseline, and 2 and 19 hours after starting the intervention</time_frame>
    <description>Magnetic resonance imaging will be performed in order to assess functional MRI during a decision task combing a reaction time test using a visual stimulus.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in jugular vein filling</measure>
    <time_frame>Once at baseline, and 10 minutes and 19 hours after starting the intervention</time_frame>
    <description>Conventional Imaging ultrasound from jugular veins veins will be used to assess vein cross sections</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in frontal vein filling</measure>
    <time_frame>Once at baseline, and 10 minutes and 19 hours after starting the intervention</time_frame>
    <description>Conventional Imaging ultrasound from the frontal veins will be used to assess vein cross sections</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in P-300</measure>
    <time_frame>Twice at baseline, and 30 minutes and 20 hours after starting the intervention</time_frame>
    <description>P-300 will be assessed via an EEG electrode during cognitive test battery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in sleep effectiveness</measure>
    <time_frame>over the entire intervention night</time_frame>
    <description>Polysomnographic recordings</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in total sleep time</measure>
    <time_frame>from 22:00 until 6:00 in all nights</time_frame>
    <description>Polysomnographic recordings</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Change in frontal skin thickness</measure>
    <time_frame>Once at baseline, and 10 minutes and 19 hours after starting the intervention</time_frame>
    <description>Conventional Imaging ultrasound will be used to assess Skin thickness at the frontal skull</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in arterial blood pressure</measure>
    <time_frame>Twice at baseline, and 10 minutes and 19 hours after starting the intervention</time_frame>
    <description>arterial blood pressure will be assessed non-invasively from a finger artery during transcranial doppler measurements</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in heart rate</measure>
    <time_frame>Twice at baseline, and 10 minutes and 19 hours after starting the intervention</time_frame>
    <description>ECG will be recorded during transcranial doppler measurements</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">13</enrollment>
  <condition>Intracranial Hypertension</condition>
  <arm_group>
    <arm_group_label>Horizontal</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Subjects will be in horizontal supine Position for 21 hours</description>
  </arm_group>
  <arm_group>
    <arm_group_label>-12° head down tilt</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will be in 12° head down supine Position for 21 hours</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>12° head down tilt</intervention_name>
    <description>supine head down tilt</description>
    <arm_group_label>-12° head down tilt</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Physically and mentally healthy male test subjects that are able and declare in&#xD;
             writing their willingness to participate in the entire study and successfully passed&#xD;
             the psychological and medical screening&#xD;
&#xD;
          -  Aged between 18-55 years old with a Body Mass Index (BMI) of 20-28 kg/m2, weight&#xD;
             between 65-100 kg, and a height between 158-195 cm&#xD;
&#xD;
          -  Demonstrable medical insurance and official certificate of absence of criminal record&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Inability to sleep on the back&#xD;
&#xD;
          -  Drug, medication or alcohol abuse (regular consumption of more than 20-30 g&#xD;
             alcohol/day)&#xD;
&#xD;
          -  Smoking within the past 6 months prior to study commencement&#xD;
&#xD;
          -  Migraine or other chronic head aches&#xD;
&#xD;
          -  Previous psychiatric illness&#xD;
&#xD;
          -  Subjects suffering from weak concentration&#xD;
&#xD;
          -  History of psychological or central nervous disorders&#xD;
&#xD;
          -  Hiatus hernia&#xD;
&#xD;
          -  Gastro-oesophageal reflux&#xD;
&#xD;
          -  Diabetes mellitus&#xD;
&#xD;
          -  Pronounced orthostatic intolerance (&lt; 10 min standing)&#xD;
&#xD;
          -  Kidney disorder: deviations from normal values for creatinine in plasma. (Normal&#xD;
             value: Creatinine &lt; 1.20 mg/dl)&#xD;
&#xD;
          -  Thyroid gland disorder: deviations from normal values for thyroid stimulating Hormone&#xD;
             (TSH) in plasma. (Normal range: TSH 0.55-4.80 mUnits/l)&#xD;
&#xD;
          -  Anaemia: Hb under normal values (Normal values of Hb for men: 13.5-17.5 g/l)&#xD;
&#xD;
          -  Elevated risk of thrombosis&#xD;
&#xD;
          -  High likelihood of coagulopathy assessed by a clinical standard questionnaire&#xD;
&#xD;
          -  Chronic back complaints&#xD;
&#xD;
          -  History of lumbar surgery&#xD;
&#xD;
          -  History of lumbar spine trauma&#xD;
&#xD;
          -  Motor or sensory deficits as assessed by neurological examination&#xD;
&#xD;
          -  Contraindications against MRI&#xD;
&#xD;
          -  Imprisoned at the time of the study&#xD;
&#xD;
          -  Taking medications that may impair cognitive function, autonomic function or any of&#xD;
             the study procedures&#xD;
&#xD;
          -  Ophthalmological conditions including glaucoma, retinopathy, severe cataracts, eye&#xD;
             trauma or implants&#xD;
&#xD;
          -  Any other medical condition that the investigators consider a contraindication to the&#xD;
             study procedures that would make it unsafe or confound the measurements.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jörn E Rittweger, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>German Aerospace Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>DLR German Aerospace Center</name>
      <address>
        <city>Cologne</city>
        <zip>51147</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>March 2017</verification_date>
  <study_first_submitted>November 18, 2016</study_first_submitted>
  <study_first_submitted_qc>November 23, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 29, 2016</study_first_posted>
  <last_update_submitted>March 1, 2017</last_update_submitted>
  <last_update_submitted_qc>March 1, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">March 3, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Cognitive functioning</keyword>
  <keyword>Brain tissue oxygenation</keyword>
  <keyword>cerebral perfusion</keyword>
  <keyword>head down tilt</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Intracranial Hypertension</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT02976168
org study id: IPCog
nct id: NCT02976168
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
The aim of the study is to understand the relationship between intracranial pressure
      regulation, cerebral tissue oxygenation and cognitive functioning. More specifically, the
      study tests the hypothesis that head down tilt will increase intracranial pressure (not
      measured in this study, but demonstrated in previous studies), will induce venous congestion
      and facial swelling, decrease intracranial tissue oxygenation and hamper brain functioning.
      The objectives of the study therefore are to assess young healthy people during head-down
      tilt (HDT), and to assess cognitive brain functioning, cerebral tissue oxygenation
      (non-invasively), frontal skin thickness, cerebral perfusion and neuronal functioning via
      event-related potentials.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Change in cognitive test battery score
time frame: Twice at baseline, and 30 minutes and 20 hours after starting the intervention
description: The test battery includes sensomotoric speed, psychomotor vigilance, visual analysis of items, abstract thinking and mathematical processing
measure: Change in mid cerebral artery blood flow velocity
time frame: Twice at baseline, and 10 minutes and 19 hours after starting the intervention
description: Transcranial Doppler measurements
measure: Change in cerebral tissue oxygenation
time frame: Twice at baseline, and 10 minutes and 19 hours after starting the intervention
description: Near-infrared measurement
measure: Magnetic resonance Imaging: Change in cerebral blood flow
time frame: Once at baseline, and 2 and 19 hours after starting the intervention
description: Magnetic resonance imaging will be performed in order to gain information about intracranial blood flow.
measure: Magnetic resonance Imaging: Change in resting state functional MRI (fMRI)
time frame: Once at baseline, and 2 and 19 hours after starting the intervention
description: Magnetic resonance imaging will be performed to assess resting state functional MRI.
measure: Magnetic resonance Imaging: Change in fMRI Response to decision task
time frame: Once at baseline, and 2 and 19 hours after starting the intervention
description: Magnetic resonance imaging will be performed in order to assess functional MRI during a decision task combing a reaction time test using a visual stimulus.
measure: Change in jugular vein filling
time frame: Once at baseline, and 10 minutes and 19 hours after starting the intervention
description: Conventional Imaging ultrasound from jugular veins veins will be used to assess vein cross sections
measure: Change in frontal vein filling
time frame: Once at baseline, and 10 minutes and 19 hours after starting the intervention
description: Conventional Imaging ultrasound from the frontal veins will be used to assess vein cross sections
measure: Change in P-300
time frame: Twice at baseline, and 30 minutes and 20 hours after starting the intervention
description: P-300 will be assessed via an EEG electrode during cognitive test battery
measure: Change in sleep effectiveness
time frame: over the entire intervention night
description: Polysomnographic recordings
measure: Change in total sleep time
time frame: from 22:00 until 6:00 in all nights
description: Polysomnographic recordings
measure: Change in frontal skin thickness
time frame: Once at baseline, and 10 minutes and 19 hours after starting the intervention
description: Conventional Imaging ultrasound will be used to assess Skin thickness at the frontal skull
measure: Change in arterial blood pressure
time frame: Twice at baseline, and 10 minutes and 19 hours after starting the intervention
description: arterial blood pressure will be assessed non-invasively from a finger artery during transcranial doppler measurements
measure: Change in heart rate
time frame: Twice at baseline, and 10 minutes and 19 hours after starting the intervention
description: ECG will be recorded during transcranial doppler measurements
arm group label: Horizontal
arm group type: No Intervention
description: Subjects will be in horizontal supine Position for 21 hours
arm group label: -12° head down tilt
arm group type: Experimental
description: Subjects will be in 12° head down supine Position for 21 hours
intervention type: Other
intervention name: 12° head down tilt
description: supine head down tilt
arm group label: -12° head down tilt
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Jörn E Rittweger, MD
role: Principal Investigator
affiliation: German Aerospace Center
facility: 
country: Germany
responsible party type: Sponsor
mesh term: Intracranial Hypertension
sharing ipd: Undecided