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Completed

NCT Number: NCT04405128

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Leicester

Leicester, LE1 5WW, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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 Imaging

Diagnostic Test

Brain MRI for investigation of brain tissue motion in the presence of suspected stroke.

Primary outcomes

  1. MRI measurement

    Time frame: Up to 5 days.

    This study will perform brain MRI for brain tissue motion for selective patients with suspected stroke.

  2. 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.

Sponsors and collaborators

Lead sponsor

University of Leicester

Other

Collaborators

  • Nihon Kohden

Registry information

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
May 28, 2020
Registry last updated
Sep 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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