RecruitingNCT07113353

Non-Invasive ICP Monitoring Study

Non-Invasive Intracranial Pressure Waveform Dynamics


Sponsor

University of Texas Southwestern Medical Center

Enrollment

30 participants

Start Date

Apr 10, 2026

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria3

  • 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 Criteria2

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

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Interventions

DEVICEBrain4Care

Non-invasive intracranial pressure monitor


Locations(1)

UT Southwestern Medical Center

Coppell, Texas, United States

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NCT07113353


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