Traumatic Brain InjuryNOVEL ICPNCT04548596
NOninVasive Intracranial prEssure From Transcranial doppLer Ultrasound Development of a Comprehensive Database of Multimodality Monitoring Signals for Brain-Injured Patients
An observational study of Traumatic Brain Injury and Subarachnoid Hemorrhage, run by Emory University at 3 sites in United States.
Trial summary
This is an observational study in neurocritical care units at University of California San Francisco Medical Center (UCSFMC), Zuckerberg San Francisco General Hospital (ZSFGH), UC Davis, and Emory University. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Traumatic Brain Injury, Subarachnoid Hemorrhage, Intracerebral Hemorrhage
- What is being tested?
- Transcranial Doppler
- How many people
- 162 participants
- Where
- 3 sitesUnited States
- Study dates
- 10 Sep 2014to 30 Apr 2025
- 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
- No healthy volunteers
- Adult, Older adult
Study population: The investigators aim to collect multimodality high-resolution physiological signals from brain injured patients: traumatic brain injury, subarachnoid and intracerebral hemorrhage, liver failure, and ischemic stroke.
Who may be able to join
- Male or female subjects 18 years of age and older
- Subjects who have an ICP Monitoring device
Who cannot join
- Unstable medical illness such as recordings might interfere with medical care.
- Subjects that don't have a viable temporal window to insonate the MCA.
- Subjects that have skull fractures that the attending or study investigators believe participation would add clinical risk to the subject.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Emory University
Atlanta, Georgia, 30322
UC Davis
Davis, California, 95616
University of California San Francisco
San Francisco, California, 94143
About this study
This is an observational study in neurocritical care units at University of California San Francisco Medical Center (UCSFMC), Zuckerberg San Francisco General Hospital (ZSFGH), UC Davis, and Emory University. In this study, the investigators will primarily use the monitor mode of the Transcranial Doppler (TCD, non-invasive FDA approved device) to record cerebral blood flow velocity (CBFV) signals from the Middle Cerebral Artery and Internal Carotid Artery. TCD data and intracranial pressure (ICP) data will be collected in the following four scenarios. Each recording is up to 60 minutes in length.
Multimodality high-resolution physiological signals will be collected from brain injured patients: traumatic brain injury, subarachnoid and intracerebral hemorrhage, liver failure, and ischemic stroke. This is not a hypothesis-driven study but rather a signal database development project with a goal to collect multimodality brain monitoring data to support development and validation of algorithms that will be useful for future brain monitoring devices. In particular, the collected data will be used to support:
Read more
Development and validation of noninvasive intracranial pressure (nICP) algorithms.
Development and validation of continuous monitoring of neurovascular coupling state for brain injury patients
Development and validation of noninvasive approaches of detecting elevated ICP state.
Development and validation of approaches to determine most likely causes of ICP elevation.
Development and validation of approaches to detect acute cerebral hemodynamic response to various neurovascular procedures.
- Conditions
- Traumatic Brain Injury, Subarachnoid Hemorrhage, Intracerebral Hemorrhage, Liver Failure, Ischemic Stroke
- Being tested
- Transcranial Doppler
- Medical subject headings
- Brain Injuries, Traumatic, Subarachnoid Hemorrhage, Cerebral Hemorrhage, Liver Failure, Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial DopplerDiagnostic test
In this study, the investigators will primarily use the monitor mode of the Transcranial Doppler (TCD, non-invasive FDA approved device) to record cerebral blood flow velocity (CBFV) signals from the Middle Cerebral Artery and Internal Carotid Artery. TCD data and intracranial pressure (ICP) data will be collected in the following four scenarios. Each recording is up to 60 minutes in length:
External ventricular drain (EVD) closed to drainage for a 24 hour period as part of the EVD weaning protocol per standard of care (SOC): The Initial reading will be done within 4 hours of EVD closing. The second reading will be done within 4 hours of anticipated removal of EVD.
EVD closed most of the time and opened to drainage when the ICP becomes elevated per SOC
EVD with Intra-Parenchymal fiber optical ICP sensor per SOC
Intra-Parenchymal fiber optical ICP sensor per SOC
What is being measured
The primary outcome is the main question the study is designed to answer.
Multimodality high-resolution signals from brain-injured patients
The investigators aim to collect multimodality high-resolution physiological signals from brain-injured patients. This is not a hypothesis-driven study but rather a signal database development project with a goal to collect multimodality brain monitoring data to support development and validation of algorithms that will be useful for future brain monitoring devices.
Measured: at completion of the study up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2020
- Study start10 Sep 2014
- Primary completion30 Apr 2025
- Study completion30 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 162 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, San Francisco, National Institute of Neurological Disorders and Stroke (NINDS)
- Responsible party
- Principal investigator, Xiao Hu, Emory University
- Investigators
- Xiao Hu, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04548596
- Sponsor's protocol ID
- STUDY00004039
- Other IDs
- Pro00105151, R01NS106905
- Acronym
- NOVEL ICP
- Status last verified
- Sep 2025
- First submitted
- 3 Sep 2020
- Last updated
- 18 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NOninVasive Intracranial prEssure From Transcranial doppLer Ultrasound Development of a Comprehensive Database of Multimodality Monitoring Signals for Brain-Injured Patients
- ClinicalTrials.gov ID
- NCT04548596
- Acronym / sponsor ID
- NOVEL ICP / STUDY00004039
- Conditions
- Traumatic Brain Injury, Subarachnoid Hemorrhage, Intracerebral Hemorrhage, Liver Failure, Ischemic Stroke
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 162 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- University of California, San Francisco, National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- 10 Sep 2014 (actual)
- Primary completion
- 30 Apr 2025 (actual)
- Study completion
- 30 Apr 2025 (actual)
- First posted
- 14 Sep 2020 (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.
This is an observational study in neurocritical care units at University of California San Francisco Medical Center (UCSFMC), Zuckerberg San Francisco General Hospital (ZSFGH), UC Davis, and Emory University. In this study, the investigators will primarily use the monitor mode of the Transcranial Doppler (TCD, non-invasive FDA approved device) to record cerebral blood flow velocity (CBFV) signals from the Middle Cerebral Artery and Internal Carotid Artery. TCD data and intracranial pressure (ICP) data will be collected in the following four scenarios. Each recording is up to 60 minutes in length.
Multimodality high-resolution physiological signals will be collected from brain injured patients: traumatic brain injury, subarachnoid and intracerebral hemorrhage, liver failure, and ischemic stroke. This is not a hypothesis-driven study but rather a signal database development project with a goal to collect multimodality brain monitoring data to support development and validation of algorithms that will be useful for future brain monitoring devices. In particular, the collected data will be used to support:
Development and validation of noninvasive intracranial pressure (nICP) algorithms.
Development and validation of continuous monitoring of neurovascular coupling state for brain injury patients
Development and validation of noninvasive approaches of detecting elevated ICP state.
Development and validation of approaches to determine most likely causes of ICP elevation.
Development and validation of approaches to detect acute cerebral hemodynamic response to various neurovascular procedures.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The investigators aim to collect multimodality high-resolution physiological signals from brain injured patients: traumatic brain injury, subarachnoid and intracerebral hemorrhage, liver failure, and ischemic stroke.
Key inclusion criteria (2 listed)
- Male or female subjects 18 years of age and older
- Subjects who have an ICP Monitoring device
Key exclusion criteria (3 listed)
- Unstable medical illness such as recordings might interfere with medical care.
- Subjects that don't have a viable temporal window to insonate the MCA.
- Subjects that have skull fractures that the attending or study investigators believe participation would add clinical risk to the subject.
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 |
|---|---|---|
| Transcranial DopplerIn this study, the investigators will primarily use the monitor mode of the Transcranial Doppler (TCD, non-invasive FDA approved device) to record cerebral blood flow velocity (CBFV) signals from the Middle Cerebral Artery and Internal Carotid Artery. TCD data and intracranial pressure (ICP) data will be collected in the following four scenarios. Each recording is up to 60 minutes in length: External ventricular drain (EVD) closed to drainage for a 24 hour period as part of the EVD weaning protocol per standard of care (SOC): The Initial reading will be done within 4 hours of EVD closing. The second reading will be done within 4 hours of anticipated removal of EVD. EVD closed most of the time and opened to drainage when the ICP becomes elevated per SOC EVD with Intra-Parenchymal fiber optical ICP sensor per SOC Intra-Parenchymal fiber optical ICP sensor per SOC | Diagnostic test | – |
Primary outcome
Multimodality high-resolution signals from brain-injured patients
Time frame: at completion of the study up to 3 years
The investigators aim to collect multimodality high-resolution physiological signals from brain-injured patients. This is not a hypothesis-driven study but rather a signal database development project with a goal to collect multimodality brain monitoring data to support development and validation of algorithms that will be useful for future brain monitoring devices.
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 18 Sep 2025.
- Individual participant dataSharing planned: No
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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.
Xiao Hu principal investigator
Emory University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Traumatic Brain Injury and Subarachnoid Hemorrhage, run by Emory University at 3 sites 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 3 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 18 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Multimodality high-resolution signals from brain-injured patients (time frame: at completion of the study up to 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Sep 2025.