Transcranial Doppler Using Wearable Ultrasound Patch

The main objective of this research is to measure the Doppler signal by the ultrasonic patch. Blood flow measurement is critical for vasospasm, stroke, and embolism monitoring on patients in the ICU or understanding the neurovascular coupling on different subjects. Currently, A conventional transcranial Doppler (TCD) probe is widely used for these applications. A headset design must be applied and fixed on the participants to obtain stable blood flow spectra. However, the TCD headset is operator dependent. The operator needs to be a trained expert and hold the ultrasound probe to get accurate blood flow velocity information. The stretchable and wearable non-invasive ultrasonic patch can not only free the operator's hands but can also provide long-term continuous monitoring, which is not possible by using the current operator-dependent ultrasound machine. The device can be conformal to the skin and attached to the skin surface.

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Key information

Conditions

Medical Device Complication Brain Diseases Brain Injuries Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Craniocerebral Trauma Nervous System Diseases Stroke Trauma, Nervous System Vascular Diseases Vasospasm Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Structural and Materials Engineering (SME) building Room 310

San Diego, California, 92122, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

Able to provide informed consent.
In relatively good health with no serious medical conditions.

Exclusion criteria

Inability to sign the informed consent.
History of the following conditions: Heart attack, low blood pressure, aortic stenosis/carotid artery stenosis (also known as heart valve disease), glaucoma (a group of eye conditions that damage the optic nerve) or retinopathy (a disease of the eye retina).

Treatment and study plan

conventional transcranial Doppler probe and wearable ultrasound patch.

Device

Comparison of the measurements from conventional transcranial Doppler probe and wearable ultrasound patch.

Primary outcomes

Device comparison to standard monitoring (conventional transcranial Doppler)

Time frame: 1.5 years

Clinical feasibility of the measurements from the non-invasive ultrasound patch in comparison to a conventional transcranial Doppler probe on 60 participants. Specifically, the blood flow specturm of different arterial segments including middle cerebral artery, anterior cerebral artery, posterior cerebral artery, vertebral artery, basal artery, internal carotid artery, and ophthalmic artery will be measured by the wearable ultrasound patch and the conventional transcranial Doppler probe. The agreement of these two device on peak systolic velocity, mean flow velocity, and end diastolic velocity of the measurements will be evaulated using the Bland-Altman plot.

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Registry information

Official study title

Non-invasive Monitoring of Blood Flow in the Brain by Using a Wearable Ultrasound Patch

Acronym: TCD

Important dates

Study start: 2022
Primary completion: 2024
Study completion: 2024
First posted: Oct 10, 2023
Registry last updated: Apr 10, 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.

Published trials that share one or more normalized conditions with this study.

Completed