Prospective Observational Multimodal Neuromonitoring in Adult NSICU Patients

NCT07577713 | Not Yet Recruiting

• 1 other identifier: STU20260827
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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 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.

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

Outcome Measures

Primary Outcomes (4)

• 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).

  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).

  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.

  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.

  ICU admission through Day 14 post-rupture

Secondary Outcomes (5)

• SedLine Patient State Index values in relation to sedation exposure and clinical neurological status

  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

  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

  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

  ICU Day 1 through Day 14

• Functional status at 90 days post-discharge assessed by modified Rankin Scale via medical record review

  90 days post-hospital discharge

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

UT Southwestern Medical Center - Clements University Hospital NSICU

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Subarachnoid Hemorrhage; Brain Injuries, Traumatic; Cerebral Hemorrhage; Ischemic Stroke; Delayed Emergence from Anesthesia; Brain Diseases

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Brain Injuries; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Stroke; Postoperative Complications

Study Officials

• Noah Jouett, DO, PhD

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Noah Jouett, DO, PhD

CONTACT

2147862783; Noah.Jouett@UTSouthwestern.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Department of Anesthesiology and Pain Management

Study Record Dates

• First Submitted: April 18, 2026
• First Posted: May 11, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2029
• Last Updated: May 11, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)