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Clinical Trials in the USA / NCT06368648
Recruiting Observational

CoMind Early Feasibility Study

NCT06368648 · tracked via the Priya Life Science USA tracker
Sponsor
CoMind Technologies Limited
Phase
Observational
Started
2024-11-27
Last updated
2026-10-30

Condition(s) studied

Intracranial PressureIntracranial Pressure ChangesTraumatic Brain InjuryIntracerebral HemorrhageEncephalitisEncephalopathyHydrocephalusStrokeAutoregulation

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • 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 — 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. — From enrollment to the end of observation (either 3 weeks after removal of the CoMind device or until ICU discharge, whichever event is sooner)
    The threshold limit of agreement will be evaluated at three levels corresponding to a model with clinical utility that is optimal, high, or moderate clinical utility. These levels of clinical utility are defined as follows: ● Optimal clinical utility: a model trained using CoMind CBFi and ABP can achieve LOA with invasive ICP less-than or equal to +/-2 mmHg in the range of ICP between 10-30 mmHg, and less-than or equal to +/-4 mmHg in the ranges of 0-10 mmHg, and 30-50 mmHg. ● High clinical utility: a model trained using CoMind CBFi and ABP can achieve LOA with invasive ICP less-than or equal to +/-3 mmHg in the range of ICP between 10-30 mmHg, and less-than or equal to +/-5 mmHg in the ranges of 0-10 mmHg, and 30-50 mmHg. ● Moderate clinical utility: a model that achieves LOA with invasive ICP less-than or equal to +/-4 mmHg in the range of ICP between 10-30 mmHg, and less-than or equal to +/-6 mmHg in the ranges of 0-10 mmHg, and 30-50 mmHg.

Trial sites (17)

FacilityCityRegionStatus
Banner University Medical Center Phoenix Arizona Recruiting
UC Davis Medical Center Sacramento California Recruiting
Christiana Care Wilmington Delaware Completed
Medstar Health Washington D.C. District of Columbia Recruiting
Jackson Memorial Hospital Miami Florida Recruiting
University of Iowa Hospital and Clinics Iowa City Iowa Recruiting
The University of Kansas Medical Center Kansas City Kansas Completed
Washington University Medical Center St Louis Missouri Recruiting
Albany Medical College Albany New York Completed
Stony Brook University Hospital Stony Brook New York Recruiting
WakeMed Raleigh North Carolina Recruiting
Ohio State University Columbus Ohio Recruiting
Oregon Health & Science University Portland Oregon Recruiting
University of Pennsylvania Hospital Philadelphia Pennsylvania Recruiting
Vanderbilt University Medical Center Nashville Tennessee Recruiting
Inova Fairfax Medical Campus Falls Church Virginia Completed
University of Washington, Harborview Seattle Washington Recruiting

Other trials for the same condition

Assessment of CSF Shunt Flow and Headaches With a Thermal Measurement Device Recruiting
SIMPLAAFY Clinical Trial Active, not recruiting
Traumatic Brain Injury and Stroke Long Term Outcome Recruiting
Ankle Robotics After Stroke Recruiting
Elite AF IDE Trial (Elite AF) Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06368648 on ClinicalTrials.gov ↗ ← All trials in the USA