NOninVasive Intracranial prEssure From Transcranial doppLer Ultrasound Development of a Comprehensive Database of Multimodality Monitoring Signals for Brain-Injured Patients

NCT04548596 | Completed

• 3 other identifiers: STUDY00004039Pro00105151R01NS106905
• Study Type: observational
• Target: 162
• Locations: 1 country
• Sites: 3

Brief 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. 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.

Conditions

Traumatic Brain Injury; Subarachnoid Hemorrhage; Intracerebral Hemorrhage; Liver Failure; Ischemic Stroke

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• Male or female subjects 18 years of age and older
• Subjects who have an ICP Monitoring device

You may not qualify if:

• 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.

Sponsors & Collaborators

• Emory University: lead
• University of California, San Francisco: collaborator
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (3)

UC Davis

Davis, California, 95616, United States

Location

University of California San Francisco

San Francisco, California, 94143, United States

Location

Emory University

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic; Subarachnoid Hemorrhage; Cerebral Hemorrhage; Liver Failure; Ischemic Stroke

Interventions

Ultrasonography, Doppler, Transcranial

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Intracranial Hemorrhages; Cerebrovascular Disorders; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hepatic Insufficiency; Liver Diseases; Digestive System Diseases; Stroke

Intervention Hierarchy (Ancestors)

Echoencephalography; Neuroradiography; Neuroimaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Radiography; Ultrasonography; Ultrasonography, Doppler; Diagnostic Techniques, Neurological; Investigative Techniques

Study Officials

• Xiao Hu

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Acting Professor

Study Record Dates

• First Submitted: September 3, 2020
• First Posted: September 14, 2020
• Study Start: September 10, 2014
• Primary Completion: April 30, 2025
• Study Completion: April 30, 2025
• Last Updated: September 18, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)