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Brain TV (Tissue Velocimetry) for Emergency Assessment of Acquired Brain Injury

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ClinicalTrials.gov Identifier: NCT04405128
Recruitment Status : Recruiting
First Posted : May 28, 2020
Last Update Posted : July 31, 2020
Sponsor:
Collaborator:
Nihon Kohden
Information provided by (Responsible Party):
University of Leicester

Brief Summary:
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.

Condition or disease Intervention/treatment
Acquired Brain Injury Traumatic Brain Injury Stroke Diagnostic Test: Transcranial Tissue Doppler (TCTD) Diagnostic Test: Brain MRI

Detailed Description:
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.

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Study Type : Observational
Estimated Enrollment : 250 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Brain TV (Tissue Velocimetry) for Emergency Assessment of Acquired Brain Injury
Actual Study Start Date : August 1, 2019
Estimated Primary Completion Date : January 1, 2023
Estimated Study Completion Date : January 1, 2023

Intervention Details:
  • Diagnostic Test: Transcranial Tissue Doppler (TCTD)
    Doppler ultrasound technique called 'Brain Tissue Velocimetry" (Brain TV), to investigate brain tissue motion over the cardiac cycle.
  • Diagnostic Test: Brain MRI
    Brain MRI for investigation of brain tIssue motion in the presence of acute acquired brain injury.


Primary Outcome Measures :
  1. TCTD measurement [ Time Frame: Up to 5 days. ]
    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.

  2. MRI measurement [ Time Frame: Up to 5 days. ]
    This study will perform brain MRI for brain tissue motion for selective patients with acquired brain injury



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants with suspected acute acquired brain injury will be identified and recruited by the Emergency Department (ED) research team and/or members of the direct care team within the Hyper Acute Stroke Unit (HASU).
Criteria

Inclusion Criteria:

  • Participant (or consultee) is willing and able to give informed consent (or assent) for participation in the study.
  • Adult, aged 18 years or over.
  • Suspected Acquired Brain Injury (any severity).

Exclusion Criteria:

  • Unable (in the investigators' opinion), or unwilling, to comply with the study requirements.
  • Patients with pre-existing chronic brain conditions that may make affect informed consent, such as severe learning difficulties, dementia, or Alzheimer's disease, will be excluded.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04405128


Contacts
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Contact: Emma M Chung, PhD 01162525839 emlc1@le.ac.uk

Locations
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United Kingdom
University Hospitals of Leicester NHS Trust Recruiting
Leicester, United Kingdom, LE1 5WW
Contact: Emma Chung    +44 1162525839    emlc1@le.ac.uk   
Sponsors and Collaborators
University of Leicester
Nihon Kohden
Investigators
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Principal Investigator: Emma M Chung, PhD University of Leicester
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Responsible Party: University of Leicester
ClinicalTrials.gov Identifier: NCT04405128    
Other Study ID Numbers: 0679
First Posted: May 28, 2020    Key Record Dates
Last Update Posted: July 31, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Emergencies
Wounds and Injuries
Disease Attributes
Pathologic Processes
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System