Recruiting

Non-Invasive Monitor

Sponsor:

University of Texas Southwestern Medical Center

Code:

NCT07113353

Conditions

Intracranial Pressure

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Brain4Care

Study Details

Brief 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. 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.

Conditions

Intracranial Pressure

Study ID

NCT07113353

Start date

Apr 10, 2026

Status verified date

Apr, 2026

Completion date

Oct 1, 2027

Anticipated

Primary completion date

Oct 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not 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

Study Design

Enrollment

30 participants

Anticipated

Interventions and Outcome Measures

Interventions

Brain4Care

Non-invasive intracranial pressure monitor

Primary outcome measure

  • P2/P1 Ratio [ Time Frame: Subject enrollment to study completion up to 100 weeks ]

Central Contacts and Locations

Central contacts

Noah Jouett, DO, PhD

214-633-3911noah.jouett@utsouthwestern.edu

Locations

UT Southwestern Medical Center

Recruiting

Coppell, Texas, United States, 75019

Contacts

Noah Jouett, DO/PhD

214-786-2783noah.jouett@utsouthwestern.edu

More Information

Sponsor

University of Texas Southwestern Medical Center

Last update posted

Apr 22, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Texas Southwestern Medical Center on 2026-04-22.