Transcranial Doppler Using Wearable Ultrasound Patch

NCT06073145 | Completed

• 1 other identifier: 805201
• Study Type: observational
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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.

Interventions

conventional transcranial Doppler probe and wearable ultrasound patch. DEVICE

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

Blood flow monitoring in the brain

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants without any serious medical conditions.

You may qualify if:

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

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

Structural and Materials Engineering (SME) building Room 310

San Diego, California, 92122, United States

Location

MeSH Terms

Conditions

Brain Injuries; Brain Diseases; Stroke

Condition Hierarchy (Ancestors)

Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Cerebrovascular Disorders; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Sheng Xu, PhD

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 13, 2023
• First Posted: October 10, 2023
• Study Start: September 27, 2022
• Primary Completion: April 2, 2024
• Study Completion: April 8, 2024
• Last Updated: April 10, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: 1.5 years
• Access Criteria: Anyone can access it through research articles.

Locations

US (1)