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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04405128
• Other study ID #: 0679
• Status: Recruiting
• Start date: August 1, 2019
• Est. completion date: January 1, 2023

Study information

• Verified date: August 2021
• Source: University of Leicester
• Contact: Emma M Chung, PhD
• Phone: 01162525839
• Email: emlc1[@]le.ac.uk
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: January 1, 2023
• Est. primary completion date: January 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acquired Brain Injury
• Brain Injuries
• Brain Injuries, Traumatic
• Emergencies
• Stroke
• Traumatic Brain Injury
• Wounds and Injuries

Intervention

Diagnostic Test:
• Transcranial Tissue Doppler (TCTD)
Doppler ultrasound technique called 'Brain Tissue Velocimetry" (Brain TV), to investigate brain tissue motion over the cardiac cycle.
• Brain MRI
Brain MRI for investigation of brain tIssue motion in the presence of acute acquired brain injury.

Locations

Country	Name	City	State
United Kingdom	University Hospitals of Leicester NHS Trust	Leicester

Sponsors (2)

Lead Sponsor	Collaborator
University of Leicester	Nihon Kohden

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 acquired brain injury (ABI) to evaluate the potential for clinical device development.	Up to 5 days.
Primary	MRI measurement	This study will perform brain MRI for brain tissue motion for selective patients with acquired brain injury	Up to 5 days.