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

Completed

Conditions studied: Traumatic Brain Injury, Subarachnoid Hemorrhage, Intracerebral Hemorrhage, Liver Failure, Ischemic Stroke

In brief

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.

Key facts

Study ID

NCT04548596

Run by

Emory University

People needed

162

Starts

2014-09-10

Expected to finish

2025-04-30

Last updated by the study team

2025-09-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• UC Davis — Davis, California, United States
• University of California San Francisco — San Francisco, California, United States
• Emory University — Atlanta, Georgia, United States

Full record on ClinicalTrials.gov

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