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| ID | Type | Description | Link |
|---|---|---|---|
| Pro00105151 | Other Identifier | Duke University | |
| R01NS106905 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| University of California, San Francisco | OTHER |
| National Institute of Neurological Disorders and Stroke (NINDS) | NIH |
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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcranial Doppler | Diagnostic 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | at completion of the study up to 3 years |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Xiao Hu | Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UC Davis | Davis | California | 95616 | United States | ||
| University of California San Francisco |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Jan 3, 2025 | Jul 24, 2025 |
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| San Francisco |
| California |
| 94143 |
| United States |
| Emory University | Atlanta | Georgia | 30322 | United States |
| ICF_000.pdf |
| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| D013345 | Subarachnoid Hemorrhage |
| D002543 | Cerebral Hemorrhage |
| D017093 | Liver Failure |
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D020300 | Intracranial Hemorrhages |
| D002561 | Cerebrovascular Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D048550 | Hepatic Insufficiency |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D020521 | Stroke |
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| ID | Term |
|---|---|
| D017585 | Ultrasonography, Doppler, Transcranial |
| ID | Term |
|---|---|
| D004453 | Echoencephalography |
| D009485 | Neuroradiography |
| D059906 | Neuroimaging |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011859 | Radiography |
| D014463 | Ultrasonography |
| D018608 | Ultrasonography, Doppler |
| D003943 | Diagnostic Techniques, Neurological |
| D008919 | Investigative Techniques |
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