- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04405128
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
Status
Recruiting
Conditions
Intervention / Treatment
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:
- Emma Chung
- Phone Number: +44 1162525839
- Email: emlc1@le.ac.uk
-
-
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.
Sponsor
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0679
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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