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

• Conditions: Stroke

• Registration Number: NCT04405128
• Lead Sponsor: University of Leicester

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.

Study Timeline

• Study Start: 2019-08-01
• Study First Submitted: 2020-05-20
• Study First Submitted QC: 2020-05-26
• Study First Posted: 2020-05-28
• Status Verified: 2021-08
• Last Update Submitted: 2021-09-27
• Last Update Posted: 2021-09-29
• Primary Completion: 2023-01-01
• Study Completion: 2023-01-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 250

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (1)

University of Leicester; 🇬🇧 Leicester, United Kingdom