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NCT Number: NCT06368648

CoMind Early Feasibility Study

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.

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Key information

Conditions

Intracranial Pressure Autoregulation Brain Diseases Brain Injuries Brain Injuries, Traumatic Cardiovascular Diseases Central Nervous System Diseases Cerebral Hemorrhage Cerebrovascular Disorders Craniocerebral Trauma Encephalitis Encephalopathy Hemorrhage Hydrocephalus Intracerebral Hemorrhage Intracranial Hemorrhages Intracranial Pressure Changes Nervous System Diseases Neuroinflammatory Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Stroke Trauma, Nervous System Traumatic Brain Injury Vascular Diseases Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

UC Davis Medical Center, Sacramento, California, United States

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About this study

A prospective, observational study, determined as non-significant risk by the Central IRB, to assess and improve performance of a non-invasive ICP estimation system. The development of non-invasive systems is intended to replace the need for invasive ICP monitors. Participants serve as their own controls with concurrent, synchronous measurements of ICP (measured invasively as per standard clinical practice), Arterial Blood Pressure (ABP- measured invasively as per standard clinical practice), and measurements of a novel non- invasive cerebral blood-flow index (CBFi) from the CoMind One EFS device. These signals will be recorded simultaneously. The ABP and CBFi will serve as inputs to a model which outputs a non-invasive estimate of ICP, and the invasive ICP signal will be used to supervise and evaluate the performance of the non-invasive ICP estimation model. A large volume of data shall be collected for the purposes of training and testing the non-invasive ICP model. The Sponsor will report limits of agreement (LOA) between data-driven estimates of ICP and the invasively measured signal. In addition, this study will compare metrics built on non-invasive estimation of ICP or CBFi that indicate the state of CAR, and the limits of Autoregulation.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.
  • Open wounds on the forehead such that CoMind One EFS Sensor cannot be safely placed over an area of intact skin
  • Presenting with radiographic evidence of a non-intact skull at the recording site on admission.
  • 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.
  • Patients with decompressive craniectomy will be excluded unless a CoMind One EFS recording can be made from intact skull.

Treatment and study plan

Primary outcomes

  1. 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)

  2. 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)

    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.

Secondary outcomes

  1. Demonstration that non-invasive ICP estimation using the CoMind One EFS device is insensitive to differences in skin tone across the population.

    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)

  2. Demonstration of a non-invasive ICP model that can classify the transition between ICP 'states', i.e. transitions between low ICP (less than 20 mmHg), and high ICP (greater than 20 mmHg).

    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)

  3. Demonstration of a non-invasive ICP waveform prediction model and assessment of its accuracy against the invasively-measured ICP waveform.

    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)

  4. Demonstration of an non-invasive ICP model that can predict trends in 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)

Other outcomes

  1. A comparison of metrics of CAR derived from CoMind One EFS CBFi, CoMind One EFS device estimates of ICP, and 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Blake Butler

CONTACT

[email protected]

8554493806

David Diedo

CONTACT

[email protected]

305-290-1680

Sponsors and collaborators

Lead sponsor

CoMind Technologies Limited

Industry

Collaborators

  • Lindus Health

Registry information

Official study title

An Early Feasibility Study for the Development of a Model to Non-Invasively Estimate Intracranial Pressure (ICP) and New Metrics of Cerebral Autoregulation (CAR) Using the CoMind One EFS Device

Acronym: CoMind EFS

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Apr 16, 2024
Registry last updated
Feb 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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