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

Traumatic Brain Injury Clinical Trial

— NOVEL ICP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04548596
• Other study ID #: STUDY00004039
• Secondary ID: Pro00105151R01NS
• Status: Recruiting
• Start date: September 10, 2014
• Est. completion date: May 30, 2024

Study information

• Verified date: May 2024
• Source: Emory University
• Contact: Xiao Hu, PhD
• Email: xiao.hu[@]emory.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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), 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 432
• Est. completion date: May 30, 2024
• Est. primary completion date: May 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Cerebral Hemorrhage
• Hemorrhage
• Intracerebral Hemorrhage
• Ischemic Stroke
• Liver Failure
• Subarachnoid Hemorrhage
• Traumatic Brain Injury

Intervention

Diagnostic Test:
• Transcranial Doppler
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

Locations

Country	Name	City	State
United States	Emory University	Atlanta	Georgia
United States	UC Davis	Davis	California
United States	Duke University	Durham	North Carolina
United States	University of California San Francisco	San Francisco	California

Sponsors (3)

Lead Sponsor	Collaborator
Emory University	National Institute of Neurological Disorders and Stroke (NINDS), University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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