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

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.

Completed

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Key information

Conditions

Traumatic Brain Injury Brain Diseases Brain Injuries Brain Injuries, Traumatic Cardiovascular Diseases Central Nervous System Diseases Cerebral Hemorrhage Cerebrovascular Disorders Craniocerebral Trauma Digestive System Diseases Hemorrhage Hepatic Insufficiency Intracerebral Hemorrhage Intracranial Hemorrhages Ischemic Stroke Liver Diseases Liver Failure Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Stroke Subarachnoid Hemorrhage Trauma, Nervous System Vascular Diseases Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

UC Davis, Davis, California, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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.

Treatment and study plan

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

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Emory University

Other

Collaborators

National Institute of Neurological Disorders and Stroke (NINDS)
University of California, San Francisco

Registry information

Acronym: NOVEL ICP

Important dates

Study start: 2014
Primary completion: 2025
Study completion: 2025
First posted: Sep 14, 2020
Registry last updated: Sep 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed