Recruiting

CoMindCoMind Early Feasibility Study

Sponsor:

CoMind Technologies Limited

Code:

NCT06368648

Conditions

Intracranial Pressure

Intracranial Pressure Changes

Traumatic Brain Injury

Intracerebral Hemorrhage

Encephalitis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

The purpose of this research, which has been determined as non-significant risk by the central IRB overseeing the study, is to obtain information to help further develop a machine (a medical device) to measure the pressure around the brain from the outside (this pressure is called intracranial pressure or ICP). Monitoring and managing ICP is an important part of care for patients with conditions such as Traumatic Brain Injury (TBI). However, the current way of measuring ICP requires surgery to drill a hole into the skull, and therefore can introduce additional risks such as infections and pain.

Recent research has shown it may be possible to measure ICP without needing surgery. This technology is in development, but large amounts of data is required to build these new devices.

Through collecting a large database of information from patients who have both the routine surgical device and the research device applied to their head, the research team will work to develop and test an effective and potentially safer way of monitoring patient ICP.

Conditions

Intracranial Pressure

Intracranial Pressure Changes

Traumatic Brain Injury

Intracerebral Hemorrhage

Encephalitis

Study ID

NCT06368648

Start date

Nov 27, 2024

Status verified date

Sep, 2026

Completion date

Nov, 2026

Anticipated

Primary completion date

Nov, 2026

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

581 participants

Anticipated

Interventions and Outcome Measures

Arms

Patients receiving invasive ICP and ABP monitoring as their standard of care

Patients who are receiving invasive Intracranial Pressure (ICP) monitoring and invasive Arterial Blood Pressure (ABP) monitoring as per standard practice will serve as their own controls.

Primary outcome measure

A test of the difference in estimation errors between two non-invasive ICP estimation models: one trained with ABP and CoMind One EFS CBFi, and one trained only using ABP [ Time Frame: From enrollment to the end of observation (either 3 weeks after removal of the CoMind device or until ICU discharge, whichever event is sooner) ]
Models trained using CoMind CBFi and ABP will be evaluated based on their limits of agreement (LOA) with invasive ICP. [ Time Frame: From enrollment to the end of observation (either 3 weeks after removal of the CoMind device or until ICU discharge, whichever event is sooner) ]

Central Contacts and Locations

Central contacts

David Diedo

305-290-1680 david@comind.io

Blake Butler

8554493806 blake@lindushealth.com

Locations

UC Davis Medical Center

Recruiting

Sacramento, California, United States, 95817

Contacts

Trial Coordinator

916-551-3234 savnguyen@ucdavis.edu

Principal Investigator:

Jeffrey Vitt, MD

Medstar Health

Recruiting

Washington D.C., District of Columbia, United States, 20010

Contacts

Trial Coordinator

2028773519 mary.a.bellon@medstar.net

Principal Investigator:

Jason Chang, MD

Jackson Memorial Hospital

Recruiting

Miami, Florida, United States, 33136

Contacts

Trial Coordinator

305-243-3056 LFisher@med.miami.edu

Principal Investigator:

Jonathan Jagid, MD

University of Iowa Hospital and Clinics

Recruiting

Iowa City, Iowa, United States, 52242

Contacts

Trial Coordinator

319-356-0575 daniel-waldschmidt@uiowa.edu

Principal Investigator:

Katherine Jensen, MD

Washington University Medical Center

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Trial Coordinator

3142732240 bfiori@wustl.edu

Principal Investigator:

Omokhaye Higo, MD

Stony Brook University Hospital

Recruiting

Stony Brook, New York, United States, 11794

Contacts

Trial Coordinator

631-444-2970 Darcy.Halper@stonybrookmedicine.edu

Principal Investigator:

Sofia Geralemou, MD

WakeMed

Recruiting

Raleigh, North Carolina, United States, 27610

Contacts

Research Coordinator

919-350-7026 jcassels@wakemed.org

Principal Investigator:

Travis Manasco

Ohio State University

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Research Coordinator

(614) 293-3559 Alberto.Uribe@osumc.edu

Principal Investigator:

Andrew Springer, MD

Oregon Health & Science University

Recruiting

Portland, Oregon, United States, 97239

Contacts

Clinical Research Manager

503-494-6233 fellersa@ohsu.edu

Principal Investigator:

Ines Koerner, MD

University of Pennsylvania Hospital

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Trial Coordinator

267-254-4745 gabrielle.dupre@pennmedicine.upenn.edu

Principal Investigator:

Danielle Sandsmark, MD, PHD

Vanderbilt University Medical Center

Recruiting

Nashville, Tennessee, United States, 37232

Contacts

Research Nurse Specialist

615-875-1969 julia.l.mitchell@vumc.org

Principal Investigator:

Christopher Hughes, MD

University of Washington, Harborview

Recruiting

Seattle, Washington, United States, 98104

Contacts

Research Coordinator

206-744-4634 ajames1@uw.edu

Principal Investigator:

Abhijit Lele, MD

More Information

Sponsor

CoMind Technologies Limited

Last update posted

Sep 4, 2026

Last verified

Sep, 2026

Keywords

Intracranial Pressure
Traumatic Brain Injury
Cerebral Autoregulation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by CoMind Technologies Limited on 2026-09-04.