NCT07113353

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
17mo left

Started Apr 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress5%
Apr 2026Oct 2027

First Submitted

Initial submission to the registry

July 29, 2025

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 8, 2025

Completed
8 months until next milestone

Study Start

First participant enrolled

April 10, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2027

Last Updated

April 22, 2026

Status Verified

April 1, 2026

Enrollment Period

6 months

First QC Date

July 29, 2025

Last Update Submit

April 18, 2026

Conditions

Intracranial Pressure

Outcome Measures

Primary Outcomes (1)

  • P2/P1 Ratio

    Subject enrollment to study completion up to 100 weeks

Interventions

Brain4CareDEVICE

Non-invasive intracranial pressure monitor

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Clinical

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UT Southwestern Medical Center

Coppell, Texas, 75019, United States

RECRUITING

Central Study Contacts

Noah Jouett, DO, PhD

CONTACT

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

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

July 29, 2025

First Posted

August 8, 2025

Study Start

April 10, 2026

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

October 1, 2027

Last Updated

April 22, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)