Transcranial Doppler Using Wearable Ultrasound Patch (TCD)

Non-invasive Monitoring of Blood Flow in the Brain by Using a 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.

Study Overview

• Status: Completed
• Conditions: Stroke; Brain Diseases; Brain Injuries; Vasospasm; Medical Device Complication
• Intervention / Treatment: Device: conventional transcranial Doppler probe and wearable ultrasound patch.

• Study Type: Observational
• Enrollment (Actual): 36

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92122
      • Structural and Materials Engineering (SME) building Room 310

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Participants without any serious medical conditions.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Blood flow monitoring in the brain; 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.	Device: conventional transcranial Doppler probe and wearable ultrasound patch.; Comparison of the measurements from conventional transcranial Doppler probe and wearable ultrasound patch.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of California, San Diego
• Investigators: Principal Investigator: Sheng Xu, PhD, University of California, San Diego

Study record dates

Study Major Dates

• Study Start (Actual): September 27, 2022
• Primary Completion (Actual): April 2, 2024
• Study Completion (Actual): April 8, 2024

Study Registration Dates

• First Submitted: September 13, 2023
• First Submitted That Met QC Criteria: October 3, 2023
• First Posted (Actual): October 10, 2023

Study Record Updates

• Last Update Posted (Actual): April 10, 2024
• Last Update Submitted That Met QC Criteria: April 8, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Brain Diseases
• Other Study ID Numbers: 805201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The study protocol, statistical analysis plan, and clinical study report will be shared and discussed in the research articles.
• IPD Sharing Time Frame: 1.5 years
• IPD Sharing Access Criteria: Anyone can access it through research articles.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No