Prospective Observational Multimodal Neuromonitoring in Adult NSICU Patients

Part of paid clinical trials in Dallas, Texas.

Sponsor
University of Texas Southwestern Medical Center
Study ID
NCT07577713
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Study Details

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 Dates

Start date
Jul 31, 2026
Status verified
Apr 2026
Primary completion
Sep 30, 2028
Completion
Sep 30, 2029

Study Design

Enrollment
300 participants (estimated)

Arms

  • Arm: 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.

Primary Outcome Measure

Proportion of enrolled participants with analyzable Brain4Care extensometry (P2/P1 ratio) recording across NSICU diagnoses [ Time Frame: Through ICU Day 14 or hospital discharge, whichever occurs first ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UT Southwestern Medical Center - Clements University Hospital NSICUDallasTexas75390
Noah Jouett, DO, PhD
[email protected]
2147862783
Noah Jouett, DO, PhD (PRINCIPAL_INVESTIGATOR)
Ulrike Hoffmann, MD, PhD (SUB_INVESTIGATOR)
DaiWai Olson, PhD, RN (SUB_INVESTIGATOR)

Find similar trials in Dallas, TX

By condition
Stroke
By specialty
NeurologyBrain disorders
By research site
UT Southwestern Medical Center - Clements University Hospital NSICU· Dallas, TX

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