Intracranial PressureNCT07113353
Non-Invasive ICP Monitoring Study
An observational study of Intracranial Pressure, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
Measuring the pressure inside the skull, which is called intracranial pressure, is important to treat severe neurological illness. Currently, measuring intracranial pressure requires doctors to place an invasive pressure monitor. Recently, a non-invasive intracranial pressure monitor has been developed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intracranial Pressure
- What is being tested?
- Brain4Care
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Apr 2026to 1 Oct 2027
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Clinical
Who may be able to join
- Adult patients (age >18) undergoing craniotomy for any indication requiring hyperosmolar agents as a part of their surgery
- Adult patients (age >18) in the neuro-oncology or neurosurgery clinic who are receiving diagnostic/therapeutic lumbar puncture as a part of their ordinary care
- Adult patients (age >18) in the neurosurgery clinic with ventriculo-peritoneal shunts who require adjustments to increase or decrease drainage of cerebrospinal fluid.
Who cannot join
- Age <18
- Lacking capacity to provide informed consent on their own behalf
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
- Recruiting
UT Southwestern Medical Center
Coppell, Texas, 75019
Noah Jouett, DO/PhD, 214-786-2783, noah.jouett@utsouthwestern.edu
About this study
Official title: Non-Invasive Intracranial Pressure Waveform Dynamics
Measuring the pressure inside the skull, which is called intracranial pressure, is important to treat severe neurological illness. Currently, measuring intracranial pressure requires doctors to place an invasive pressure monitor. Recently, a non-invasive intracranial pressure monitor has been developed. This monitor has a tiny pin that is placed on the head which measures the tiny movements of the skull every time the heart beats. This produces a waveform that looks very similar to an invasive intracranial pressure waveform. However, we don't know enough about how the non-invasive device to make it clinically useful yet.
Read the detailed description
Assessment of intracranial pressure (ICP) is essential in the practice of neurocritical and neurosurgical care. ICP is best assessed through direct measurement with an invasive monitor, usually done by drilling a burr hole in the skull and inserting a monitor into the brain parenchyma or a catheter into the lateral ventricle. In the absence of an invasive ICP monitor, clinicians must currently rely solely on signs and symptoms of elevated ICP (e.g. alterations in pupillary constriction to light, reduced sensorium, nausea/vomiting, etc.), which occur late in the evolution of an ICP crisis. An FDA-cleared (FDA number K240821) non-invasive ICP monitor (nICPm) has been developed by Brain4Care (Johns Creek, GA). The device is equipped with piezoelectric sensors that can detect the tiny pulsations in skull expansion with every heartbeat which corresponds to the ICP waveform. Although the nICPm does not measure ICP per se, the waveform it detects is equivalent to an ICP waveform derived from an invasive monitor and has been validated to reflect intracranial pressure. Analysis of the nICPm waveform consists of factors including the P2/P1 ratio, which is the ratio of the percussive peak and the reflective peak of the ICP waveform, and time to peak (TTP), which is the time it takes for the ICP to reach maximum amplitude. nICPm waveform analysis has been studied in various clinical contexts-but how the waveform changes in response to various ICP-lowering maneuvers is incompletely characterized. Hence the current study will investigate how the nICPm waveform behaves in patients undergoing various ICP lowering procedures as a part of their ordinary, standard-of-care treatment.
- Conditions
- Intracranial Pressure
- Being tested
- Brain4Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brain4CareDevice
Non-invasive intracranial pressure monitor
What is being measured
The primary outcome is the main question the study is designed to answer.
P2/P1 Ratio
Measured: Subject enrollment to study completion up to 100 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2025
- Study start10 Apr 2026
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracranial PressureStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Noah Jouett, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07113353
- Sponsor's protocol ID
- STU20251318
- Status last verified
- Apr 2026
- First submitted
- 29 Jul 2025
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Invasive Intracranial Pressure Waveform Dynamics
- ClinicalTrials.gov ID
- NCT07113353
- Acronym / sponsor ID
- STU20251318
- Conditions
- Intracranial Pressure
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- 10 Apr 2026 (actual)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Oct 2027 (estimated)
- First posted
- 8 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Measuring the pressure inside the skull, which is called intracranial pressure, is important to treat severe neurological illness. Currently, measuring intracranial pressure requires doctors to place an invasive pressure monitor. Recently, a non-invasive intracranial pressure monitor has been developed. This monitor has a tiny pin that is placed on the head which measures the tiny movements of the skull every time the heart beats. This produces a waveform that looks very similar to an invasive intracranial pressure waveform. However, we don't know enough about how the non-invasive device to make it clinically useful yet.
Detailed description
Assessment of intracranial pressure (ICP) is essential in the practice of neurocritical and neurosurgical care. ICP is best assessed through direct measurement with an invasive monitor, usually done by drilling a burr hole in the skull and inserting a monitor into the brain parenchyma or a catheter into the lateral ventricle. In the absence of an invasive ICP monitor, clinicians must currently rely solely on signs and symptoms of elevated ICP (e.g. alterations in pupillary constriction to light, reduced sensorium, nausea/vomiting, etc.), which occur late in the evolution of an ICP crisis. An FDA-cleared (FDA number K240821) non-invasive ICP monitor (nICPm) has been developed by Brain4Care (Johns Creek, GA). The device is equipped with piezoelectric sensors that can detect the tiny pulsations in skull expansion with every heartbeat which corresponds to the ICP waveform. Although the nICPm does not measure ICP per se, the waveform it detects is equivalent to an ICP waveform derived from an invasive monitor and has been validated to reflect intracranial pressure. Analysis of the nICPm waveform consists of factors including the P2/P1 ratio, which is the ratio of the percussive peak and the reflective peak of the ICP waveform, and time to peak (TTP), which is the time it takes for the ICP to reach maximum amplitude. nICPm waveform analysis has been studied in various clinical contexts-but how the waveform changes in response to various ICP-lowering maneuvers is incompletely characterized. Hence the current study will investigate how the nICPm waveform behaves in patients undergoing various ICP lowering procedures as a part of their ordinary, standard-of-care treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Clinical
Key inclusion criteria (3 listed)
- Adult patients (age >18) undergoing craniotomy for any indication requiring hyperosmolar agents as a part of their surgery
- Adult patients (age >18) in the neuro-oncology or neurosurgery clinic who are receiving diagnostic/therapeutic lumbar puncture as a part of their ordinary care
- Adult patients (age >18) in the neurosurgery clinic with ventriculo-peritoneal shunts who require adjustments to increase or decrease drainage of cerebrospinal fluid.
Key exclusion criteria (2 listed)
- Age <18
- Lacking capacity to provide informed consent on their own behalf
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brain4CareNon-invasive intracranial pressure monitor | Device | – |
Primary outcome
P2/P1 Ratio
Time frame: Subject enrollment to study completion up to 100 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intracranial Pressure, run by University of Texas Southwestern Medical Center 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 3 inclusion and 2 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 22 Apr 2026. 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?
Contact Noah Jouett, DO, PhD (214-633-3911, noah.jouett@utsouthwestern.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
P2/P1 Ratio (time frame: Subject enrollment to study completion up to 100 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Apr 2026.