Non-Invasive ICP Monitoring Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2026-01-30

Study Completion Date

2027-10-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Intracranial Pressure

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Brain4Care

Non-invasive intracranial pressure monitor

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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.

Exclusion Criteria

* Age \<18
* Lacking capacity to provide informed consent on their own behalf

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Noah Jouett

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Noah Jouett, DO, PhD

Role: CONTACT

Phone: 214-633-3911

Email: [email protected]

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

STU20251318

Identifier Type: -

Identifier Source: org_study_id