Transcranial Doppler Using Wearable Ultrasound Patch

Completed

• Conditions: Brain Diseases; Vasospasm; Stroke; Medical Device Complication; Brain Injuries
• Interventions: Device: conventional transcranial Doppler probe and wearable ultrasound patch.

• Registration Number: NCT06073145
• Lead Sponsor: University of California, San Diego

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-09-27
• Study First Submitted: 2023-09-13
• Study First Submitted QC: 2023-10-03
• Study First Posted: 2023-10-10
• Status Verified: 2024-04
• Primary Completion: 2024-04-02
• Study Completion: 2024-04-08
• Last Update Submitted: 2024-04-08
• Last Update Posted: 2024-04-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Blood flow monitoring in the brain	conventional transcranial Doppler probe and wearable ultrasound patch.	A group/cohort of 60 participants will be recruited. The group/cohort has a broad range distribution of different physiological parameters, such as age, gender, race, BMI, and etc.

Primary Outcome Measures

Name	Time	Method
Device comparison to standard monitoring (conventional transcranial Doppler)	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.

Trial Locations

Locations (1)

Structural and Materials Engineering (SME) building Room 310; 🇺🇸 San Diego, California, United States