Prospective Observational Multimodal Neuromonitoring in Adult NSICU Patients

Starting soon

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

In brief

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.

Key facts

Study ID

NCT07577713

Run by

University of Texas Southwestern Medical Center

People needed

300

Starts

2026-07-01

Expected to finish

2029-09-01

Last updated by the study team

2026-05-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• UT Southwestern Medical Center - Clements University Hospital NSICU — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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