Non-invasive measurement of brain pressure in patients with traumatic brain injury

Is this trial a fit for you?

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 aims to gather data to develop a non-invasive device for measuring intracranial pressure (ICP) in patients with conditions like traumatic brain injury. Participants will have both a standard invasive ICP monitor and a novel non-invasive device applied simultaneously to collect data. The study will analyze the relationship between invasive ICP measurements and non-invasive estimates to improve the accuracy of the new device. The goal is to eliminate the need for surgical procedures currently required for ICP monitoring, thereby reducing associated risks.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Male or female sex at birth, and aged 18 years or older on the date of enrollment.
2. Receiving continuous invasive ICP monitoring (Bolt or EVD) as part of standard care.
3. Invasive ICP monitor catheter penetrating the parenchyma or ventricles.
4. Receiving continuous invasive ABP monitoring as part of standard care.

Exclusion Criteria:

1. Presence of any implant (cosmetic or otherwise) in the frontal bone in such proximity to the CoMind One EFS Sensor that they might physically touch.
2. Open wounds on the forehead such that CoMind One EFS Sensor cannot be safely placed over an area of intact skin
3. Presenting with radiographic evidence of a non-intact skull at the recording site on admission.
4. If patient is enrolled in an intervention/study that may interfere with SoC ICP measurements or the CoMind One EFS device measurement then the patient is ineligible.
5. Patients with decompressive craniectomy will be excluded unless a CoMind One EFS recording can be made from intact skull.

Where it's running

• Banner University Medical Center
  Phoenix, Arizona, United States Recruiting
• UC Davis Medical Center
  Sacramento, California, United States Recruiting
• Medstar Health
  Washington D.C., District of Columbia, United States Recruiting
• Jackson Memorial Hospital
  Miami, Florida, United States Recruiting
• University of Iowa Hospital and Clinics
  Iowa City, Iowa, United States Recruiting
• Washington University Medical Center
  St Louis, Missouri, United States Recruiting

Study contacts

• Principal investigator: Ramani Balu, MD, PhD — Inova Fairfax Hospital
• Study coordinator: David Diedo
• Email: efs@comind.io
• Phone: 305-290-1680

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.