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

NCT04405128 | Completed

• 1 other identifier: 0679
• Study Type: observational
• Target: 102
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Outcome Measures

Primary Outcomes (2)

• 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.

Interventions

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Leicester: lead
• Nihon Kohden: collaborator

Study Sites (1)

University of Leicester

Leicester, LE1 5WW, United Kingdom

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

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

Study Officials

• Emma M Chung, PhD

  King's College, London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2020
• First Posted: May 28, 2020
• Study Start: August 1, 2019
• Primary Completion: January 1, 2023
• Study Completion: December 31, 2023
• Last Updated: September 20, 2024

Record last verified: 2021-08

Locations

GB (1)