CoMind Early Feasibility Study (CoMind EFS)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Stroke; Encephalitis; Traumatic Brain Injury; Intracerebral Hemorrhage; Hydrocephalus; Encephalopathy; Intracranial Pressure; Autoregulation; Intracranial Pressure Changes

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 581

Contacts and Locations

• Study Contact: Name: David Diedo; Phone Number: +447912 209019; Email: david@comind.io
• Study Contact Backup: Name: Rianna Mortimer; Phone Number: +447308 312168; Email: rianna@lindushealth.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Any participant (18 years or older) who is undergoing invasive ICP monitoring and continuous ABP monitoring as part of their normal medical treatment at selected clinical sites. The majority of such participants will have sustained a Traumatic Brain Injury (TBI), but some may have Intracerebral Haemorrhage (ICH), Encephalitis, various metabolic Encephalopathies (notably hepatic), Hydrocephalus (both communicating and non-communicating), or Stroke, although this is not an exhaustive list of participant conditions.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	From enrollment to the end of observation (either 3 weeks after removal of the CoMind device or until ICU discharge, whichever event is sooner)

Secondary Outcome Measures

Outcome Measure	Time Frame
Demonstration that non-invasive ICP estimation using the CoMind One EFS device is insensitive to differences in skin tone across the population.	From enrollment to the end of observation (either 3 weeks after removal of the CoMind device or until ICU discharge, whichever event is sooner)
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).	From enrollment to the end of observation (either 3 weeks after removal of the CoMind device or until ICU discharge, whichever event is sooner)
Demonstration of a non-invasive ICP waveform prediction model and assessment of its accuracy against the invasively-measured ICP waveform.	From enrollment to the end of observation (either 3 weeks after removal of the CoMind device or until ICU discharge, whichever event is sooner)
Demonstration of an non-invasive ICP model that can predict trends in 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)

Other Outcome Measures

Outcome Measure	Time Frame
A comparison of metrics of CAR derived from CoMind One EFS CBFi, CoMind One EFS device estimates of ICP, and 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)

Collaborators and Investigators

• Sponsor: CoMind Technologies Limited
• Collaborators: Lindus Health
• Investigators: Principal Investigator: Ramani Balu, MD, PhD, Inova Fairfax Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2024
• Primary Completion (Estimated): March 1, 2025
• Study Completion (Estimated): April 1, 2025

Study Registration Dates

• First Submitted: April 11, 2024
• First Submitted That Met QC Criteria: April 11, 2024
• First Posted (Actual): April 16, 2024

Study Record Updates

• Last Update Posted (Actual): April 16, 2024
• Last Update Submitted That Met QC Criteria: April 11, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Traumatic Brain Injury; Intracranial Pressure; Cerebral Autoregulation
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Intracranial Hemorrhages; Neuroinflammatory Diseases; Encephalitis; Brain Injuries; Hemorrhage; Brain Injuries, Traumatic; Brain Diseases; Cerebral Hemorrhage; Hydrocephalus
• Other Study ID Numbers: CP-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No