Clinical trial NCT04548596: NOninVasive Intracranial PrEssure from Transcranial DoppLer Ultrasound Development of a Comprehensive Database of Multimodality Monitoring Signals for Brain-Injured Patients
Official title: NOninVasive Intracranial PrEssure from Transcranial DoppLer Ultrasound Development of a Comprehensive Database of Multimodality Monitoring Signals for Brain-Injured Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Traumatic Brain Injury
Subarachnoid Hemorrhage
Intracerebral Hemorrhage
Liver Failure
Ischemic Stroke
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: University of California, San Francisco
name: National Institute of Neurological Disorders and Stroke (NINDS)
First posted: 2020-09-14
Enrollment: 432
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Multimodality high-resolution signals from brain-injured patients
timeFrame: at completion of the study up to 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Davis
country: United States
facility: UC Davis
state: California
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Durham
country: United States
facility: Duke University
state: North Carolina
Study officials:
affiliation: Emory University
name: Xiao Hu
role: PRINCIPAL_INVESTIGATOR
References: