StrokeNCT04405128
Brain TV (Tissue Velocimetry) for Emergency Assessment of Suspected Stroke
An observational study of Stroke, run by University of Leicester at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Transcranial Tissue Doppler (TCTD) and Brain Magnetic Resonance Imaging
- How many people
- 102 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Aug 2019to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants with suspected stroke 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).
Who may be able to join
- 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 stroke (any severity and any stroke type).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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 brain injury. This study combines transcranial tissue Doppler (TCTD) ultrasound with brain magnetic resonance imaging (MRI) to establish whether analysis of brain tissue motion provides clinically useful information for emergency diagnosis and monitoring of suspected stroke.
- Conditions
- Stroke
- Being tested
- Transcranial Tissue Doppler (TCTD), Brain Magnetic Resonance Imaging
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Tissue Doppler (TCTD)Diagnostic test
Doppler ultrasound technique called "Brain Tissue Velocimetry" (Brain TV), to investigate brain tissue motion over the cardiac cycle.
Brain Magnetic Resonance ImagingDiagnostic test
Brain MRI for investigation of brain tissue motion in the presence of suspected stroke.
What is being measured
The primary outcome is the main question the study is designed to answer.
MRI measurement
This study will perform brain MRI for brain tissue motion for selective patients with suspected stroke.
Measured: Up to 5 days.
TCTD measurement
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.
Measured: Up to 5 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2020
- Study start1 Aug 2019
- Primary completion1 Jan 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Leicester
- Sponsor type
- University, hospital or other
- Collaborators
- Nihon Kohden
- Responsible party
- Sponsor
- Investigators
- Emma M Chung, PhD, Principal investigator, King's College, London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04405128
- Sponsor's protocol ID
- 0679
- Status last verified
- Aug 2021
- First submitted
- 20 May 2020
- Last updated
- 20 Sep 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain TV (Tissue Velocimetry) for Emergency Assessment of Suspected Stroke
- ClinicalTrials.gov ID
- NCT04405128
- Acronym / sponsor ID
- 0679
- Conditions
- Stroke
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- University of LeicesterUniversity, hospital or other
- Collaborators
- Nihon Kohden
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 1 Jan 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 28 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 brain injury. This study combines transcranial tissue Doppler (TCTD) ultrasound with brain magnetic resonance imaging (MRI) to establish whether analysis of brain tissue motion provides clinically useful information for emergency diagnosis and monitoring of suspected stroke.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants with suspected stroke 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).
Key inclusion criteria (3 listed)
- 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 stroke (any severity and any stroke type).
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 Magnetic Resonance ImagingBrain MRI for investigation of brain tissue motion in the presence of suspected stroke. | Diagnostic test | – |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2024.
- Individual participant dataSharing planned: Undecided
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emma M Chung, PhD principal investigator
King's College, London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, run by University of Leicester at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MRI measurement (time frame: Up to 5 days.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2024.