Subarachnoid Hemorrhage, AneurysmalNCT07577713
Prospective Observational Multimodal Neuromonitoring in Adult NSICU Patients
An observational study of Subarachnoid Hemorrhage, Aneurysmal and Brain Injuries, Traumatic, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
This is a prospective observational cohort study of adult patients admitted to the Neurosciences Intensive Care Unit (NSICU) at UT Southwestern Medical Center. The study acquires multimodal neuromonitoring data - including SedLine quantitative EEG (qEEG) from standard-of-care monitoring, Brain4Care (B4C) noninvasive… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Subarachnoid Hemorrhage, Aneurysmal, Brain Injuries, Traumatic, Cerebral Hemorrhage
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2027to Sep 2029
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients age 18 years or older admitted to the Neurosciences Intensive Care Unit (NSICU) at UT Southwestern Medical Center. The population is intentionally broad to support observational analyses across common neurocritical care diagnoses. aSAH patients are a priority enrollment group given the scientific objectives related to characterizing the natural history of noninvasive CA parameter evolution through the DCI window.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
UT Southwestern Medical Center - Clements University Hospital NSICU
Dallas, Texas, 75390
Noah Jouett, DO, PhD, 2147862783, Noah.Jouett@UTSouthwestern.edu
Noah Jouett, DO, PhD
About this study
Official title: Prospective Observational Multimodal Neuromonitoring in Adult Neurosciences Intensive Care Unit Patients: Characterization of Noninvasive Cerebral Autoregulation Indices, Quantitative EEG, and Physiologic Correlates Across NSICU Diagnoses
This is a prospective observational cohort study of adult patients admitted to the Neurosciences Intensive Care Unit (NSICU) at UT Southwestern Medical Center. The study acquires multimodal neuromonitoring data - including SedLine quantitative EEG (qEEG) from standard-of-care monitoring, Brain4Care (B4C) noninvasive intracranial dynamics monitoring, and near-infrared spectroscopy (NIRS)-derived cerebral autoregulation (CA) indices where NIRS is already in clinical use - and links these data to bedside physiologic, medication, diagnostic, and clinical outcome variables during standard care. No alteration of clinical management occurs. The study prioritizes aneurysmal subarachnoid hemorrhage (aSAH) patients to characterize the natural history of noninvasive CA parameter evolution through the delayed cerebral ischemia (DCI) window (admission through Day 14) and provides preliminary data for subsequent interventional study design.
Read the detailed description
BACKGROUND: Patients admitted to the NSICU undergo rapid physiologic changes related to primary neurologic injury, secondary brain injury, sedation, mechanical ventilation, and evolving systemic illness. Cerebral autoregulation (CA) - the brain's intrinsic mechanism for maintaining stable perfusion across a range of systemic arterial pressures - is measurably impaired in aSAH, traumatic brain injury (TBI), intracerebral hemorrhage (ICH), and acute ischemic stroke. In aSAH, CA impairment during the 4-14 day post-rupture window is independently associated with delayed cerebral ischemia (DCI), the leading cause of preventable death and disability in survivors. Approximately 75% of aSAH patients require an external ventricular drain (EVD), which prevents standard ICP-based CA monitoring. B4C extensometry and NIRS-derived CA indices offer EVD-independent monitoring approaches whose feasibility and signal characteristics in aSAH have not been prospectively described.
DESIGN: Single-center prospective observational cohort study at the UT Southwestern NSICU. Eligible subjects may undergo B4C extensometry monitoring (the sole research-specific device under this protocol) and/or have research data recorded from existing standard-of-care clinical monitoring including SedLine qEEG, full-montage long-term monitoring EEG (where clinically ordered), NIRS, invasive ICP/CPP from EVD monitors, transcranial Doppler (TCD; standard of care for aSAH at UT Southwestern), and NeurOptics NPi automated pupillometry. The Moberg Clinical Platform (Moberg Analytics; FDA-cleared) serves as the primary data acquisition hub in the NSICU, aggregating synchronized high-resolution physiologic waveforms from existing bedside monitors without placing any additional research devices.
MONITORING MODALITIES:
Research device placed specifically for research purposes under this protocol:
- Brain4Care (B4C) extensometry: skull-mounted noninvasive sensor recording cranial compliance-related waveform morphology (P2/P1 ratio, Time to Peak), from which surrogate CA indices (nPRx, nCPPopt, nMx) are derived.
Standard-of-care clinical data recorded for research purposes (no additional devices placed):
- SedLine qEEG: clinically placed forehead sensor used for sedation monitoring as standard of care; provides Patient State Index, Spectral Edge Frequency, and raw EDF waveforms.
- Full-montage long-term monitoring EEG: from clinically ordered continuous EEG electrodes for seizure and ADR monitoring where applicable.
- NIRS (near-infrared spectroscopy): regional cerebral oxygenation; CA indices computed include cerebral oximetry index (COx) and total oxygenation reactivity index (TOxA).
- Clinical ICP/CPP waveform data from EVD transducer where present.
- TCD vasospasm surveillance (daily studies as standard of care for aSAH; peak and mean velocities, Lindegaard ratio).
- NeurOptics NPi pupillometry: NPi, constriction velocity, latency, amplitude.
- Moberg Clinical Platform: synchronized arterial blood pressure, ICP, ECG/HRV, SpO2, EtCO2, CVP, ventilator parameters, NIRS.
ASAH PRIORITY ENROLLMENT: For aSAH patients, the protocol prioritizes monitoring through ICU Day 14 to characterize the natural history of B4C-derived and NIRS-derived CA index evolution through the DCI window. An optional 90-day follow-up captures functional and neurological outcomes beyond hospital discharge.
DATA MANAGEMENT: Subjects are assigned unique study identifiers. Direct identifiers are removed from analytic datasets. De-identified data may be shared with qualified external collaborators under executed data use agreements and with applicable IRB approval. De-identified data from this study may be combined with data from the companion NSICU Autonomic Modulation Study for analyses within the approved scope of both protocols.
- Conditions
- Subarachnoid Hemorrhage, Aneurysmal, Brain Injuries, Traumatic, Cerebral Hemorrhage, Ischemic Stroke, Delayed Emergence From Anesthesia, Encephalopathy
- Keywords
- aneurysmal subarachnoid hemorrhage, delayed cerebral ischemia, cerebral autoregulation, CPPopt, MAPopt, Brain4Care, SedLine, quantitative EEG, near-infrared spectroscopy, COx, TOxA, transcranial Doppler, neurocritical care, NSICU, noninvasive intracranial monitoring, Moberg Clinical Platform, multimodal neuromonitoring
- Medical subject headings
- Subarachnoid Hemorrhage, Brain Injuries, Traumatic, Cerebral Hemorrhage, Ischemic Stroke, Delayed Emergence from Anesthesia, Brain Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Adult NSICU Patients | Adult patients age 18 years or older admitted to the NSICU at UT Southwestern Medical Center. Diagnostic groups include but are not limited to aneurysmal subarachnoid hemorrhage, traumatic brain injury, intracerebral hemorrhage, acute ischemic stroke, seizure-related presentations, postoperative neurosurgical patients, disorders of consciousness, and encephalopathy. aSAH patients represent the priority enrollment group. All participants have at least one monitoring modality acquired: B4C extensometry placed by study personnel, and/or research data recorded from existing standard-of-care SedLine, NIRS, TCD, or long-term monitoring EEG monitoring. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of enrolled participants with analyzable Brain4Care extensometry (P2/P1 ratio) recording across NSICU diagnoses
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).
Measured: Through ICU Day 14 or hospital discharge, whichever occurs first
Proportion of Brain4Care extensometry sessions with computable cerebral autoregulation indices (nPRx) across NSICU diagnoses
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).
Measured: Through ICU Day 14 or hospital discharge, whichever occurs first
NIRS-derived cerebral oximetry index (COx) trajectory through the delayed cerebral ischemia window in aSAH
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.
Measured: ICU admission through Day 14 post-rupture
NIRS-derived optimal mean arterial pressure (MAPopt) trajectory through the delayed cerebral ischemia window in aSAH
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.
Measured: ICU admission through Day 14 post-rupture
Secondary outcomes (5)
SedLine Patient State Index values in relation to sedation exposure and clinical neurological status
Characterization of SedLine-derived Patient State Index (PSI; unitless, range 0-100) in relation to sedative medication exposure, clinical neurological status, primary NSICU diagnosis, and neurological outcome at discharge. PSI values reported as median with interquartile range stratified by sedation state and diagnostic group.
Measured: Duration of ICU stay (expected 7-21 days for aSAH; varies by diagnosis)
SedLine Spectral Edge Frequency values in relation to sedation exposure and clinical neurological status
Characterization of SedLine-derived Spectral Edge Frequency (SEF95; reported in Hz) in relation to sedative medication exposure, clinical neurological status, primary NSICU diagnosis, and neurological outcome at discharge. SEF95 values reported as median with interquartile range stratified by sedation state and diagnostic group.
Measured: Duration of ICU stay (expected 7-21 days for aSAH; varies by diagnosis)
Proportion of Brain4Care extensometry monitoring sessions successfully completed across NSICU clinical care states
Percentage of Brain4Care (B4C) extensometry monitoring sessions successfully completed, reported as a single proportion stratified by clinical care state (intubated/ventilated vs. extubated; sedated vs. awake; EVD present vs. absent). Duration of analyzable monitoring epochs reported in hours. Proportion of patients with multi-session longitudinal data reported as percentage.
Measured: Through ICU Day 14 or hospital discharge
Correlation between transcranial Doppler (TCD) mean flow velocity and Brain4Care-derived noninvasive pressure reactivity index (nPRx) in aSAH
Spearman correlation coefficient between daily transcranial Doppler (TCD)-derived mean flow velocity (cm/s) and concurrently computed Brain4Care (B4C)-derived noninvasive pressure reactivity index (nPRx) in aSAH patients. Temporal association between TCD-defined vasospasm severity (Lindegaard ratio) and nPRx deterioration characterized as time-lagged cross-correlation.
Measured: ICU Day 1 through Day 14
Functional status at 90 days post-discharge assessed by modified Rankin Scale via medical record review
Functional and neurological status assessed by modified Rankin Scale (mRS) score via medical record review and/or optional structured contact at 90 days. Reported as ordinal mRS score (0-6). This component is not required for protocol completion; omission does not constitute a protocol deviation.
Measured: 90 days post-hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2026
- Study startJul 2027 (estimated)
- Primary completionSep 2028 (estimated)
- Study completionSep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subarachnoid Hemorrhage, AneurysmalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Noah Jouett, University of Texas Southwestern Medical Center
- Investigators
- Noah Jouett, DO, PhD, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07577713
- Sponsor's protocol ID
- STU20260827
- Status last verified
- Apr 2026
- First submitted
- 18 Apr 2026
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No