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

This is an observational study in neurocritical care units at University of California San Francisco Medical Center (UCSFMC), Zuckerberg San Francisco General Hospital (ZSFGH), and Duke University Medical Center. 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.

Study Overview

• Status: Recruiting
• Conditions: Liver Failure; Ischemic Stroke; Traumatic Brain Injury; Subarachnoid Hemorrhage; Intracerebral Hemorrhage
• Intervention / Treatment: Diagnostic test: Transcranial Doppler

• Study Type: Observational
• Enrollment (Estimated): 432

Contacts and Locations

• Study Contact: Name: Kaitlyn Bateh; Email: kbateh@emory.edu
• Study Contact Backup: Name: Xiao Hu

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94143
      • Recruiting
      • University of California San Francisco
      • Contact: Eliot Lee; Email: Eliot.Lee@ucsf.edu
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Recruiting
      • Emory University
      • Contact: Katie Jordan; Email: k.a.jordan@emory.edu
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Withdrawn
      • Duke University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

Inclusion Criteria:

1. Male or female subjects 18 years of age and older
2. Subjects who have an ICP monitoring device that allows for 30 minutes of continuous monitoring

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 middle cerebral artery (MCA)
3. Subjects that have skull fractures that the attending or study investigators believe participation would add clinical risk to the subject
4. Subjects that had hemicraniectomy and are still without bone flap

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Emory University
• Collaborators: National Institute of Neurological Disorders and Stroke (NINDS); University of California, San Francisco
• Investigators: Principal Investigator: Xiao Hu, Emory University

Study record dates

Study Major Dates

• Study Start (Actual): September 10, 2014
• Primary Completion (Estimated): May 30, 2024
• Study Completion (Estimated): May 30, 2024

Study Registration Dates

• First Submitted: September 3, 2020
• First Submitted That Met QC Criteria: September 11, 2020
• First Posted (Actual): September 14, 2020

Study Record Updates

• Last Update Posted (Actual): April 2, 2024
• Last Update Submitted That Met QC Criteria: April 1, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Hepatic Insufficiency; Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Liver Diseases; Craniocerebral Trauma; Trauma, Nervous System; Stroke; Intracranial Hemorrhages; Liver Failure; Ischemic Stroke; Brain Injuries; Hemorrhage; Brain Injuries, Traumatic; Subarachnoid Hemorrhage; Cerebral Hemorrhage
• Other Study ID Numbers: STUDY00004039; Pro00105151 (Other Identifier: Duke University); R01NS106905 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No