TCD: Transcranial Doppler Using Wearable Ultrasound Patch

Sponsor
University of California, San Diego (Other)
Overall Status
Recruiting
CT.gov ID
NCT06073145
Collaborator
(none)
60
1
20.9
2.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: conventional transcranial Doppler probe and wearable ultrasound patch.

Study Design

Study Type:
Observational
Anticipated Enrollment :
60 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Non-invasive Monitoring of Blood Flow in the Brain by Using a Wearable Ultrasound Patch
Actual Study Start Date :
Sep 27, 2022
Anticipated Primary Completion Date :
Jun 25, 2024
Anticipated Study Completion Date :
Jun 25, 2024

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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).

Contacts and Locations

Locations

Site City State Country Postal Code
1 Structural and Materials Engineering (SME) building Room 310 San Diego California United States 92122

Sponsors and Collaborators

  • University of California, San Diego

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Sheng Xu, Associate Professor, University of California, San Diego
ClinicalTrials.gov Identifier:
NCT06073145
Other Study ID Numbers:
  • 805201
First Posted:
Oct 10, 2023
Last Update Posted:
Oct 10, 2023
Last Verified:
Oct 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 10, 2023