<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/NCT04405128</url>
  </required_header>
  <id_info>
    <org_study_id>0679</org_study_id>
    <nct_id>NCT04405128</nct_id>
  </id_info>
  <brief_title>Brain TV (Tissue Velocimetry) for Emergency Assessment of Acquired Brain Injury</brief_title>
  <official_title>Brain TV (Tissue Velocimetry) for Emergency Assessment of Acquired Brain Injury</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Leicester</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Nihon Kohden</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Leicester</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study uses a Doppler ultrasound technique being developed at the University of Leicester&#xD;
      called 'Brain Tissue Velocimetry&quot; (Brain TV), to investigate brain tissue motion over the&#xD;
      cardiac cycle.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Brain motion is highly sensitive to heart and brain biomechanics, but the impact of brain&#xD;
      injury on brain tissue motion has yet to be explored. Preliminary brain tissue motion&#xD;
      measurements from a small number of patients suggest that brain biomechanics may be disturbed&#xD;
      in the presence of injury. This study combines Transcranial Tissue Doppler ultrasound with&#xD;
      brain MRI to establish whether analysis of brain tissue motion provides clinically useful&#xD;
      information for emergency diagnosis and monitoring of acute brain injury.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">August 1, 2019</start_date>
  <completion_date type="Anticipated">January 1, 2023</completion_date>
  <primary_completion_date type="Anticipated">January 1, 2023</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>TCTD measurement</measure>
    <time_frame>Up to 5 days.</time_frame>
    <description>The study will generate a library of Brain TV measurements for exploratory (descriptive) analysis and imaging of brain tissue pulsations in patients with acquired brain injury (ABI) to evaluate the potential for clinical device development.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>MRI measurement</measure>
    <time_frame>Up to 5 days.</time_frame>
    <description>This study will perform brain MRI for brain tissue motion for selective patients with acquired brain injury</description>
  </primary_outcome>
  <enrollment type="Anticipated">250</enrollment>
  <condition>Acquired Brain Injury</condition>
  <condition>Traumatic Brain Injury</condition>
  <condition>Stroke</condition>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Transcranial Tissue Doppler (TCTD)</intervention_name>
    <description>Doppler ultrasound technique called 'Brain Tissue Velocimetry&quot; (Brain TV), to investigate brain tissue motion over the cardiac cycle.</description>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Brain MRI</intervention_name>
    <description>Brain MRI for investigation of brain tIssue motion in the presence of acute acquired brain injury.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Participants with suspected acute acquired brain injury will be identified and recruited by&#xD;
        the Emergency Department (ED) research team and/or members of the direct care team within&#xD;
        the Hyper Acute Stroke Unit (HASU).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participant (or consultee) is willing and able to give informed consent (or assent)&#xD;
             for participation in the study.&#xD;
&#xD;
          -  Adult, aged 18 years or over.&#xD;
&#xD;
          -  Suspected Acquired Brain Injury (any severity).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unable (in the investigators' opinion), or unwilling, to comply with the study&#xD;
             requirements.&#xD;
&#xD;
          -  Patients with pre-existing chronic brain conditions that may make affect informed&#xD;
             consent, such as severe learning difficulties, dementia, or Alzheimer's disease, will&#xD;
             be excluded.&#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>Emma M Chung, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Leicester</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Emma M Chung, PhD</last_name>
    <phone>01162525839</phone>
    <email>emlc1@le.ac.uk</email>
  </overall_contact>
  <location>
    <facility>
      <name>University Hospitals of Leicester NHS Trust</name>
      <address>
        <city>Leicester</city>
        <zip>LE1 5WW</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Emma Chung</last_name>
      <phone>+44 1162525839</phone>
      <email>emlc1@le.ac.uk</email>
    </contact>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>May 20, 2020</study_first_submitted>
  <study_first_submitted_qc>May 26, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 28, 2020</study_first_posted>
  <last_update_submitted>September 27, 2021</last_update_submitted>
  <last_update_submitted_qc>September 27, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 29, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Brain Injuries</mesh_term>
    <mesh_term>Brain Injuries, Traumatic</mesh_term>
    <mesh_term>Emergencies</mesh_term>
    <mesh_term>Wounds and Injuries</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/NCT04405128
org study id: 0679
nct id: NCT04405128
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
This study uses a Doppler ultrasound technique being developed at the University of Leicester
      called 'Brain Tissue Velocimetry" (Brain TV), to investigate brain tissue motion over the
      cardiac cycle.
Brain motion is highly sensitive to heart and brain biomechanics, but the impact of brain
      injury on brain tissue motion has yet to be explored. Preliminary brain tissue motion
      measurements from a small number of patients suggest that brain biomechanics may be disturbed
      in the presence of injury. This study combines Transcranial Tissue Doppler ultrasound with
      brain MRI to establish whether analysis of brain tissue motion provides clinically useful
      information for emergency diagnosis and monitoring of acute brain injury.
observational model: Case-Control
time perspective: Prospective
measure: TCTD measurement
time frame: Up to 5 days.
description: The study will generate a library of Brain TV measurements for exploratory (descriptive) analysis and imaging of brain tissue pulsations in patients with acquired brain injury (ABI) to evaluate the potential for clinical device development.
measure: MRI measurement
time frame: Up to 5 days.
description: This study will perform brain MRI for brain tissue motion for selective patients with acquired brain injury
intervention type: Diagnostic Test
intervention name: Transcranial Tissue Doppler (TCTD)
description: Doppler ultrasound technique called 'Brain Tissue Velocimetry" (Brain TV), to investigate brain tissue motion over the cardiac cycle.
intervention type: Diagnostic Test
intervention name: Brain MRI
description: Brain MRI for investigation of brain tIssue motion in the presence of acute acquired brain injury.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Emma M Chung, PhD
role: Principal Investigator
affiliation: University of Leicester
last name: Emma M Chung, PhD
phone: 01162525839
email: emlc1@le.ac.uk
facility: 
status: Recruiting
contact: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Brain Injuries
mesh term: Brain Injuries, Traumatic
mesh term: Emergencies
mesh term: Wounds and Injuries
sharing ipd: Undecided