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

Last updated: September 12, 2025
Sponsor: Emory University
Overall Status: Completed

Phase

N/A

Condition

Liver Failure

Hemorrhage

Traumatic Brain Injury

Treatment

Transcranial Doppler

Clinical Study ID

NCT04548596
STUDY00004039
R01NS106905
Pro00105151
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Male or female subjects 18 years of age and older

  2. Subjects who have an ICP Monitoring device

Exclusion

Exclusion Criteria:

  1. Unstable medical illness such as recordings might interfere with medical care.

  2. Subjects that don't have a viable temporal window to insonate the MCA.

  3. Subjects that have skull fractures that the attending or study investigators believeparticipation would add clinical risk to the subject.

Study Design

Total Participants: 162
Treatment Group(s): 1
Primary Treatment: Transcranial Doppler
Phase:
Study Start date:
September 10, 2014
Estimated Completion Date:
April 30, 2025

Connect with a study center

  • UC Davis

    Davis, California 95616
    United States

    Site Not Available

  • University of California San Francisco

    San Francisco, California 94143
    United States

    Site Not Available

  • UC Davis

    Davis 5341704, California 5332921 95616
    United States

    Site Not Available

  • University of California San Francisco

    San Francisco 5391959, California 5332921 94143
    United States

    Site Not Available

  • Emory University

    Atlanta, Georgia 30322
    United States

    Site Not Available

  • Emory University

    Atlanta 4180439, Georgia 4197000 30322
    United States

    Site Not Available

  • Duke University

    Durham, North Carolina 27710
    United States

    Site Not Available

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