Medical Device ComplicationTCDNCT06073145
Transcranial Doppler Using Wearable Ultrasound Patch
An observational study of Medical Device Complication and Brain Injuries, run by University of California, San Diego at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Medical Device Complication, Brain Injuries, Brain Diseases
- What is being tested?
- conventional transcranial Doppler probe and wearable ultrasound patch.
- Type of treatment
- Medical device
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Sep 2022to 8 Apr 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants without any serious medical conditions.
Who may be able to join
- Able to provide informed consent.
- In relatively good health with no serious medical conditions.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
Structural and Materials Engineering (SME) building Room 310
San Diego, California, 92122
About this study
Official title: 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.
- Conditions
- Medical Device Complication, Brain Injuries, Brain Diseases, Stroke, Vasospasm
- Being tested
- conventional transcranial Doppler probe and wearable ultrasound patch.
- Medical subject headings
- Brain Injuries, Brain Diseases, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
conventional transcranial Doppler probe and wearable ultrasound patch.Device
Comparison of the measurements from conventional transcranial Doppler probe and wearable ultrasound patch.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: conventional transcranial Doppler probe and wearable ultrasound patch. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2023
- Study start27 Sep 2022
- Primary completion2 Apr 2024
- Study completion8 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Medical Device ComplicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sheng Xu, University of California, San Diego
- Investigators
- Sheng Xu, PhD, Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06073145
- Sponsor's protocol ID
- 805201
- Acronym
- TCD
- Status last verified
- Apr 2024
- First submitted
- 13 Sep 2023
- Last updated
- 10 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The study protocol, statistical analysis plan, and clinical study report will be shared and discussed in the research articles.
Publications
Zhou S, Gao X, Park G, Yang X, Qi B, Lin M, Huang H, Bian Y, Hu H, Chen X, Wu RS, Liu B, Yue W, Lu C, Wang R, Bheemreddy P, Qin S, Lam A, Wear KA, Andre M, Kistler EB, Newell DW, Xu S. Transcranial volumetric imaging using a conformal ultrasound patch. Nature. 2024 May;629(8013):810-818. doi: 10.1038/s41586-024-07381-5. Epub 2024 May 22.
PubMed 38778234
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive Monitoring of Blood Flow in the Brain by Using a Wearable Ultrasound Patch
- ClinicalTrials.gov ID
- NCT06073145
- Acronym / sponsor ID
- TCD / 805201
- Conditions
- Medical Device Complication, Brain Injuries, Brain Diseases, Stroke, Vasospasm
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- 27 Sep 2022 (actual)
- Primary completion
- 2 Apr 2024 (actual)
- Study completion
- 8 Apr 2024 (actual)
- First posted
- 10 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Blood flow monitoring in the brain | – | Device: 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants without any serious medical conditions.
Key inclusion criteria (2 listed)
- Able to provide informed consent.
- In relatively good health with no serious medical conditions.
Key exclusion criteria (2 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| conventional transcranial Doppler probe and wearable ultrasound patch.Comparison of the measurements from conventional transcranial Doppler probe and wearable ultrasound patch. | Device | Blood flow monitoring in the brain |
Primary outcome
Device comparison to standard monitoring (conventional transcranial Doppler)
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2024.
- Derived from this study: PubMed 38778234Zhou S, Gao X, Park G, Yang X, Qi B, Lin M, Huang H, Bian Y, Hu H, Chen X, Wu RS, Liu B, Yue W, Lu C, Wang R, Bheemreddy P, Qin S, Lam A, Wear KA, Andre M, Kistler EB, Newell DW, Xu S. Transcranial volumetric imaging using a conformal ultrasound patch. Nature. 2024 May;629(8013):810-818. doi: 10.1038/s41586-024-07381-5. Epub 2024 May 22.
- Individual participant dataSharing planned: Yes. The study protocol, statistical analysis plan, and clinical study report will be shared and discussed in the research articles.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sheng Xu, PhD principal investigator
University of California, San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Medical Device Complication and Brain Injuries, run by University of California, San Diego at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Device comparison to standard monitoring (conventional transcranial Doppler) (time frame: 1.5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06073145, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2024.