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Clinical Trials/NCT04405128
NCT04405128
Unknown
Not Applicable

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

University of Leicester1 site in 1 country250 target enrollmentAugust 1, 2019
ConditionsStroke

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stroke
Sponsor
University of Leicester
Enrollment
250
Locations
1
Primary Endpoint
MRI measurement
Last Updated
4 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
August 1, 2019
End Date
January 1, 2023
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility 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.

Outcomes

Primary Outcomes

MRI measurement

Time Frame: Up to 5 days.

This study will perform brain MRI for brain tissue motion for selective patients with suspected stroke.

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 suspected stroke to evaluate the potential for clinical device development.

Study Sites (1)

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