Recruiting

Observational Study

Sponsor:

University of Louisville

Code:

NCT06511804

Conditions

Brain Injuries

Intracranial Pressure Increase

Monitoring

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Intracranial Pressure Noninvasive Monitoring

Study Details

Brief summary:

The purpose of this clinical research project is to employ Mespere LifeSciences NeurOs Cerebral Oximetry system, equipped with noninvasive sensors approved by the FDA, to monitor and investigate the correlation within a cohort of patients suffering from traumatic brain injury (TBI), stroke, brain tumor, and brain bleeding. This study aims to investigate and establish the correlation between blood vessel functionality parameters-specifically, Vasodilation/Constriction Index (VDC), Vascular Resistance Index (VR), and Volume Reactivity Index (VRx)-with the crucial physiological indicators, Intracranial Pressure (ICP) and Mean Arterial Pressure (MAP). By doing so, the investigators seek to address fundamental questions surrounding cerebral hemodynamics and autoregulation in various neurological conditions.

Conditions

Brain Injuries

Intracranial Pressure Increase

Monitoring

Study ID

NCT06511804

Start date

Nov 17, 2024

Status verified date

May, 2025

Completion date

Jun 30, 2026

Anticipated

Primary completion date

Dec 30, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

Subjects who meet all the following inclusion criteria may be included:

1. Adults (> 18 years of age);
2. Able and willing to provide written informed consent for participation by self or legally authorized representatives.
3. Clinical diagnosis of traumatic brain injury (TBI), brain hemorrhage, brain tumor, neurotrauma (including closed head injuries, penetrating head injuries, or other forms of neurotrauma), hemorrhage (intracerebral or subarachnoid), or stroke.
4. Continuous Blood Pressure Monitoring: Patients must have continuous blood pressure monitoring in place during the study period, obtained from an arterial line. This criterion ensures that we have real-time data on mean arterial pressure (MAP) and systolic pressure (SBP).
5. Intracranial Pressure (ICP) Monitoring: Patients must have intracranial pressure (ICP) monitoring in place during the study period. This criterion ensures that we can assess the correlation between our blood vessel functionality parameters (VDC, VR, and VRx) and ICP, a key indicator of intracranial dynamics.

Exclusion Criteria:

1. Subjects who meet any of the following exclusion criteria will be excluded:
2. Expected to be at increased risk due to study participation (e.g. due to hemodynamic instability), in the medical opinion of an investigator;
3. Pregnant as determined per site standard practice;
4. Previously participated in this study, or are enrolled in another research study that could be expected to interfere with participation, in the opinion of the investigator;
5. Require or are anticipated to require emergent medical care in which study participation may reasonably delay his/her medical care or increase risk or unfavorable outcome, in the opinion of the investigator;
6. Allergy to adhesive tape;
7. Ongoing photodynamic therapy.

Study Design

Enrollment

25 participants

Anticipated

Interventions and Outcome Measures

Interventions

Intracranial Pressure Noninvasive Monitoring

Mespere sensors will be placed on the temporal areas of the head in patients with invasive intracranial pressure monitoring. Blood pressures, intracranial pressure, and Mespere parameters will be recorded.

Primary outcome measure

  • cerebral hemodynamics and autoregulation as assessed by the noninvasive blood vessel functionality parameters-Vasodilation/Constriction Index (VDC), Vascular Resistance Index (VR), and Volume Reactivity Index (VRx) [ Time Frame: 1 hour ]

Central Contacts and Locations

Locations

University of Louisville Health

Recruiting

Louisville, Kentucky, United States, 40202

Contacts

Principal Investigator:

Jiapeng Huang, Md, PhD

More Information

Sponsor

University of Louisville

Last update posted

May 30, 2025

Last verified

May, 2025

Keywords

  • intracranial pressure
  • monitoring
  • noninvasive

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Louisville on 2025-05-30.