Non-invasive intracranial pressure monitoring with a skull-mounted sensor
Official title: Non-Invasive Intracranial Pressure Waveform Dynamics
Run by University of Texas Southwestern Medical Center · NCT07113353 · Data updated 2026-11-12
Researchers will try a small skull-mounted sensor to see if it records intracranial pressure waveforms like invasive monitors in adults who are having craniotomy, lumbar puncture, or shunt adjustment procedures.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 30 (estimated) |
| Sponsor | University of Texas Southwestern Medical Center Academic / other |
| Locations | 1 site (Coppell, Texas) |
| Status | Recruiting |
| Started | April 10, 2026 |
| Main results expected | October 1, 2026 |
| Study ends | October 1, 2027 |
| Registry record updated | April 22, 2026 |
| Trial ID | NCT07113353 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults over 18 who can provide informed consent and who are undergoing craniotomy with planned hyperosmolar therapy, diagnostic/therapeutic lumbar puncture, or ventriculo-peritoneal shunt adjustment are the intended participants.
✕Probably not a fit
Children under 18, patients lacking the capacity to consent, and adults not undergoing the specified procedures are unlikely to benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study uses a Brain4Care non-invasive monitor with piezoelectric sensors placed on the scalp to capture tiny skull pulsations that produce ICP-like waveforms. Waveform metrics such as the P2/P1 ratio and time to peak (TTP) will be compared to clinical changes during procedures that alter intracranial pressure (craniotomy with hyperosmolar therapy, diagnostic/therapeutic lumbar puncture, and ventriculo-peritoneal shunt adjustments). Although the device has prior validation and an FDA clearance for waveform equivalence, the study will characterize how those waveforms change in response to ICP-lowering maneuvers. All measurements are collected during routine clinical care at UT Southwestern in consenting adults.
Why it matters
Potential benefit: If successful, the device could allow non-invasive, bedside monitoring of intracranial pressure waveforms, reducing the need for invasive probes and enabling earlier intervention.
How similar studies have gone: Prior validation work and an FDA clearance support waveform equivalence between this non-invasive device and invasive ICP monitors, but its response during ICP-lowering maneuvers is not yet fully characterized.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
UT Southwestern Medical Center
Coppell, Texas, United States Recruiting
Study contacts
- Study coordinator: Noah Jouett, DO, PhD
- Email: noah.jouett@utsouthwestern.edu
- Phone: 214-633-3911
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.