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

September 27, 2021 updated by: University of Leicester
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.

Study Overview

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.

Study Type

Observational

Enrollment (Anticipated)

250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Emma M Chung, PhD
  • Phone Number: 01162525839
  • Email: emlc1@le.ac.uk

Study Locations

      • Leicester, United Kingdom, LE1 5WW
        • Recruiting
        • University Hospitals Of Leicester Nhs Trust
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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).

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 5 days.
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
Up to 5 days.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Principal Investigator: Emma M Chung, PhD, University of Leicester

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2019

Primary Completion (Anticipated)

January 1, 2023

Study Completion (Anticipated)

January 1, 2023

Study Registration Dates

First Submitted

May 20, 2020

First Submitted That Met QC Criteria

May 26, 2020

First Posted (Actual)

May 28, 2020

Study Record Updates

Last Update Posted (Actual)

September 29, 2021

Last Update Submitted That Met QC Criteria

September 27, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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