NOninVasive Intracranial PrEssure from Transcranial DoppLer Ultrasound Development of a Comprehensive Database of Multimodality Monitoring Signals for Brain-Injured Patients

Recruiting

• Conditions: Subarachnoid Hemorrhage; Ischemic Stroke; Intracerebral Hemorrhage; Liver Failure; Traumatic Brain Injury

• Registration Number: NCT04548596
• Lead Sponsor: Emory University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-09-10
• Study First Submitted: 2020-09-03
• Study First Submitted QC: 2020-09-11
• Study First Posted: 2020-09-14
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-16
• Last Update Posted: 2024-12-18
• Primary Completion: 2025-06-30
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 432

Inclusion Criteria

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

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 believe participation would add clinical risk to the subject.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Multimodality high-resolution signals from brain-injured patients	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.

Trial Locations

Locations (4)

Emory University; 🇺🇸 Atlanta, Georgia, United States

University of California San Francisco; 🇺🇸 San Francisco, California, United States

Duke University; 🇺🇸 Durham, North Carolina, United States

UC Davis; 🇺🇸 Davis, California, United States