Brain TV (Tissue Velocimetry) for Emergency Assessment of Suspected Stroke

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: Completed
• Conditions: Stroke
• Intervention / Treatment: Diagnostic test: Transcranial Tissue Doppler (TCTD); Diagnostic test: Brain Magnetic Resonance Imaging

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 Type: Observational
• Enrollment (Actual): 102

Contacts and Locations

Study Locations

• United Kingdom
  • Leicester, United Kingdom, LE1 5WW
    • University of Leicester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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).

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 stroke (any severity and any stroke type).

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

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
MRI measurement	This study will perform brain MRI for brain tissue motion for selective patients with suspected stroke.	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.	Up to 5 days.

Collaborators and Investigators

• Sponsor: University of Leicester
• Collaborators: Nihon Kohden
• Investigators: Principal Investigator: Emma M Chung, PhD, King's College, London

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2019
• Primary Completion (Actual): January 1, 2023
• Study Completion (Actual): December 31, 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 20, 2024
• Last Update Submitted That Met QC Criteria: September 18, 2024
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• 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