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Brain InjuriesMespere ICPNCT06511804

Correlation Between Noninvasive Blood Vessel Functionality Parameters and Cerebral Hemodynamics in Neurocritical Care Patients

An observational study of Brain Injuries and Intracranial Pressure Increase, run by University of Louisville at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 100 years
What is being tested?
Intracranial Pressure Noninvasive Monitoring
Type of treatment
Medical device
How many people
25 participants
Where
1 siteUnited States
Study dates
17 Nov 2024to 30 Jun 2026
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 100 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Adult (18 years of age and older) that present for medical care in operating room, intensive care unit (ICU) and/or other departments will be enrolled. Only patients that are safe to conduct the study per medical judgement of the PI will be enrolled in the study. Mespere LifeSciences blood vessel functionality parameters-Vasodilation/Constriction Index (VDC), Vascular Resistance Index (VR), and Volume Reactivity Index (VRx) will not be used for any medical decisions. This evaluation will be conducted in addition to any other tests, procedures, and/or scans ordered by the participants treating physician. Patients will be required to meet inclusion criteria and meet none of the exclusion criteria. This population is representative of the general population that is expected to use the device in clinical practice.

Who may be able to join

  • Subjects who meet all the following inclusion criteria may be included:
  • Adults (> 18 years of age);
  • Able and willing to provide written informed consent for participation by self or legally authorized representatives.
  • 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.
  • 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).
  • 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.

Who cannot join

  • Subjects who meet any of the following exclusion criteria will be excluded:
  • Expected to be at increased risk due to study participation (e.g. due to hemodynamic instability), in the medical opinion of an investigator;
  • Pregnant as determined per site standard practice;
  • 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;
  • 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;
  • Allergy to adhesive tape;
  • Ongoing photodynamic therapy.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site, 1 recruiting

  • University of Louisville Health

    Louisville, Kentucky, 40202

    Jiapeng Huang, MD, PhD, 5028528157, jiapeng.huang@louisville.edu

    Jiapeng Huang, Md, PhD

    Recruiting

Other trials in United States

About this study

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.

Read the detailed description

For this research, the investigators will strategically position two noninvasive sensors on the patients' foreheads, specifically over the temporal region. It is imperative that the skin in this area is accessible, free from hair or any underlying wounds beneath the sensor. These sensors are specifically designed to gather crucial data on cerebral oxygen saturation (StO2) and blood volume index (BVI). As per FDA recommendations, should the monitoring extend beyond 6 hours, it is advisable to replace the sensor adhesive to ensure optimal functionality and accuracy. The collected information will be transmitted to the investigators' monitoring system, equipped with preinstalled software that offers real-time insights into several key parameters:

  1. Regional Tissue Oxygen Saturation (StO2): This parameter provides data on regional hemoglobin oxygen saturation in the cerebral tissue beneath the sensor. It is captured using our cerebral oximetry sensors and offers critical insights into tissue oxygenation.
  2. Blood Volume Index (BVI): BVI provides information on the regional blood-to-tissue volume ratio in the cerebral tissue beneath the sensor, again captured using our cerebral oximetry sensors. BVI is instrumental in understanding blood volume dynamics in the brain.
  3. Mean Arterial Pressure (MAP) and Systolic Blood Pressure (SBP): Real-time MAP and SBP data will be pulled from the Philips patient monitor, providing a comprehensive overview of the patient's circulatory status.
  4. Intracranial Pressure (ICP): Similar to MAP and SBP, real-time ICP data will also be pulled from the Philips patient monitor, offering valuable insights into intracranial dynamics.
  5. Vasodilation/Constriction Index (VDC): VDC is a derived parameter from BVI, signifying the relative change in blood vessel cross-sectional area. An increase indicates vessel dilation, while a decrease indicates vessel constriction. This index offers insights into cerebral vessel reactivity.
  6. Vascular Resistance Index (VR): VR is a derived parameter from BVI, indicating the percent change in blood vessel resistance based on the Hagen-Poiseuille formula. VR helps assess the resistance to blood flow within cerebral vessels.
  7. Volume Reactivity Index (VRx): VRx is a real-time moving Pearson Correlation Coefficient between Blood Volume Index (BVI) derived from our Cerebral Oximetry sensors and MAP. This parameter is derived from Pressure Reactivity Index (PRx), making VRx a non-invasive alternative to the invasive PRx. VRx is used to assess autoregulation.
Being tested
Intracranial Pressure Noninvasive Monitoring
Keywords
intracranial pressure, monitoring, noninvasive
Medical subject headings
Brain Injuries, Intracranial Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intracranial Pressure Noninvasive MonitoringDevice

    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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    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)-in patients with traumatic brain injury, stroke, brain bleeding

    Measured: 1 hour

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jul 2024
  2. Study start17 Nov 2024
  3. Primary completion30 Dec 2025 (estimated)
  4. Study completion30 Jun 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
25 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06511804
Sponsor's protocol ID
24.0331
Acronym
Mespere ICP
Status last verified
May 2025
First submitted
15 Jul 2024
Last updated
30 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • Longhitano Y, Iannuzzi F, Bonatti G, Zanza C, Messina A, Godoy D, Dabrowski W, Xiuyun L, Czosnyka M, Pelosi P, Badenes R, Robba C. Cerebral Autoregulation in Non-Brain Injured Patients: A Systematic Review. Front Neurol. 2021 Nov 16;12:732176. doi: 10.3389/fneur.2021.732176. eCollection 2021.

    PubMed 34899560

Questions about this trial

What is this clinical trial studying?

An observational study of Brain Injuries and Intracranial Pressure Increase, run by University of Louisville at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 30 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06511804, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2025.

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