Transcranial Doppler Using Wearable Ultrasound Patch

Stroke Clinical Trial

— TCD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06073145
• Other study ID #: 805201
• Status: Completed
• Start date: September 27, 2022
• Est. completion date: April 8, 2024

Study information

• Verified date: April 2024
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: April 8, 2024
• Est. primary completion date: April 2, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Brain Diseases
• Brain Injuries
• Medical Device Complication
• Stroke
• Vasospasm

Intervention

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

Locations

Country	Name	City	State
United States	Structural and Materials Engineering (SME) building Room 310	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Diego

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Device comparison to standard monitoring (conventional transcranial Doppler)	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.	1.5 years