NCT07577713Not yet recruiting
Prospective Observational Multimodal Neuromonitoring in Adult NSICU Patients
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
Source: ClinicalTrials.gov · Last updated 23 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 300 (estimated)
- First submitted
- 18 Apr 2026
- Start date
- 1 Jul 2027
- Primary completion date
- 30 Sept 2028
- Lead sponsor
- University of Texas Southwestern Medical Center
- Diseases
- Stroke
- NCT number
- NCT07577713
What you commit to
- Study type: Observational
- Planned participants: 300
- From 1 Jul 2027 to the primary completion date, 30 Sept 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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)
Age
- Age younger than 18 years
Other
- Prisoner status
- Active declination of participation by subject or legally authorized representative
- Absence of both subject and legally authorized representative consent when required
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| UT Southwestern Medical Center - Clements University Hospital NSICU Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.