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Observational Neuromonitoring Study in NSICU Patients

This study is looking at how different brain monitoring tools work in adult patients admitted to the Neurosciences Intensive Care Unit (NSICU) at UT Southwestern Medical Center. It's for people with conditions like subarachnoid hemorrhage (bleeding in the brain), traumatic brain injuries, cerebral hemorrhage, ischemic stroke, or delayed awakening from anesthesia. Researchers will collect information from standard monitoring equipment like SedLine qEEG (a brain wave test), Brain4Care (a non-invasive brain pressure monitor), and NIRS (a way to measure oxygen in the brain). The main goal is to see how well these tools can provide useful information about brain function and blood flow. This is an observational study, meaning your medical care will not change because of your participation. About 300 patients are expected to join.

Study design
This is an observational study, meaning researchers will collect information during your standard care without changing your treatment. It will include about 300 adult participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Information will be collected through ICU Day 14 or hospital discharge, whichever comes first, for most measurements. For subarachnoid hemorrhage, NIRS data will be collected from ICU admission through Day 14 post-rupture.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07577713

Prospective Observational Multimodal Neuromonitoring in Adult NSICU Patients

Not Yet Recruiting
Not specifiedAges 18+Observational
University of Texas Southwestern Medical Center
~300 participants
Updated 2026-05-11 on ClinicalTrials.gov

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Proportion of enrolled participants with analyzable Brain4Care extensometry (P2/P1 ratio) recording across NSICU diagnoses
Measured over Through ICU Day 14 or hospital discharge, whichever occurs first
+3 more outcomes measured

Conditions

Subarachnoid Hemorrhage, Aneurysmal
Brain Injuries, Traumatic
Cerebral Hemorrhage
Ischemic Stroke
Delayed Emergence From Anesthesia
Encephalopathy

Explore related trials

Cerebral HemorrhageDelayed Emergence from AnesthesiaEncephalopathyIschemic StrokeSubarachnoid HemorrhageTraumatic Encephalopathy

Where it's being run

1 sites across 1 states
Texas1

Study leadership

  • Noah Jouett, DO, PhD · PRINCIPAL_INVESTIGATOR · University of Texas Southwestern Medical Center

Who to contact

Noah Jouett, DO, PhD
[email protected]
2147862783
Email the study team

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Eligibility criteria

Inclusion

Age 18 years or older
Admitted to the NSICU at UT Southwestern Medical Center
Informed consent obtained from subject or legally authorized representative (as defined under Texas Health and Safety Code Section 166.039), or consent process underway per institutional policy
At least one study monitoring modality feasible (SedLine qEEG and/or Brain4Care extensometry); NIRS data collected where already in standard clinical use

Exclusion

Age younger than 18 years
Prisoner status
Active declination of participation by subject or legally authorized representative
Absence of both subject and legally authorized representative consent when required
Clinical condition preventing safe placement of any study monitor (e.g., extensive facial or scalp injury, surgical dressings or hardware at all possible sensor sites, open wounds at sensor locations, severe uncontrolled agitation)
Anticipated clinical data capture insufficient for meaningful analysis
Urgent clinical priorities making research monitor placement inappropriate at time of approach
Inability to provide informed consent in English; study consent materials are available in English only

What this trial measures

  • Proportion of enrolled participants with analyzable Brain4Care extensometry (P2/P1 ratio) recording across NSICU diagnosesThrough ICU Day 14 or hospital discharge, whichever occurs first

    Percentage of enrolled participants with at least one successful Brain4Care (B4C) extensometry monitoring session yielding analyzable P2/P1 ratio data. Signal quality assessed by artifact burden and adequate waveform morphology. Reported as a single proportion compared across primary NSICU diagnostic groups (aSAH, TBI, ICH, stroke, other).

  • Proportion of Brain4Care extensometry sessions with computable cerebral autoregulation indices (nPRx) across NSICU diagnosesThrough ICU Day 14 or hospital discharge, whichever occurs first

    Percentage of Brain4Care (B4C) extensometry monitoring sessions from which the noninvasive pressure reactivity index (nPRx) can be computed from B4C waveforms and concurrent arterial blood pressure data. Reported as a single proportion compared across primary NSICU diagnostic groups (aSAH, TBI, ICH, stroke, other).

  • NIRS-derived cerebral oximetry index (COx) trajectory through the delayed cerebral ischemia window in aSAHICU admission through Day 14 post-rupture

    Prospective characterization of near-infrared spectroscopy (NIRS)-derived cerebral oximetry index (COx; unitless, range -1 to +1) trajectory from NSICU admission through Day 14 in aSAH patients. Correlation of COx trajectory with DCI onset (clinical and imaging-confirmed) and neurological outcome at discharge, reported as Spearman correlation coefficients.

  • NIRS-derived optimal mean arterial pressure (MAPopt) trajectory through the delayed cerebral ischemia window in aSAHICU admission through Day 14 post-rupture

    Prospective characterization of near-infrared spectroscopy (NIRS)-derived optimal mean arterial pressure (MAPopt; reported in mmHg) trajectory from NSICU admission through Day 14 in aSAH patients. Correlation of MAPopt trajectory with DCI onset (clinical and imaging-confirmed) and neurological outcome at discharge, reported as Spearman correlation coefficients.