Intracranial PressureCoMind EFSNCT06368648
CoMind Early Feasibility Study
An observational study of Intracranial Pressure and Intracranial Pressure Changes, run by CoMind Technologies Limited at 17 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intracranial Pressure, Intracranial Pressure Changes, Traumatic Brain Injury
- How many people
- 581 participants
- Where
- 17 sitesUnited States
- Study dates
- 27 Nov 2024to Nov 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
17 sites in 1 country. Contact the study team or a site near you to ask about taking part.
17 sites in 1 country
United States17 sites, 13 recruiting
- Active, not recruiting
Albany Medical College
Albany, New York, 12208
- Recruiting
Ohio State University
Columbus, Ohio, 43210
Research Coordinator, (614) 293-3559, Alberto.Uribe@osumc.edu
Andrew Springer, MD
- Active, not recruiting
Inova Fairfax Medical Campus
Falls Church, Virginia, 22042
- Recruiting
University of Iowa Hospital and Clinics
Iowa City, Iowa, 52242
Trial Coordinator, 319-356-0575, daniel-waldschmidt@uiowa.edu
Katherine Jensen, MD
- Active, not recruiting
The University of Kansas Medical Center
Kansas City, Kansas, 66103
- Recruiting
Jackson Memorial Hospital
Miami, Florida, 33136
Trial Coordinator, 305-243-3056, LFisher@med.miami.edu
Jonathan Jagid, MD
- Recruiting
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Research Nurse Specialist, 615-875-1969, julia.l.mitchell@vumc.org
Christopher Hughes, MD
- Recruiting
University of Pennsylvania Hospital
Philadelphia, Pennsylvania, 19104
Trial Coordinator, 267-254-4745, gabrielle.dupre@pennmedicine.upenn.edu
Danielle Sandsmark, MD, PHD
- Recruiting
Banner University Medical Center
Phoenix, Arizona, 85006
Trial Coordinator, 224-300-9606, gchaconmora@arizona.edu
Khalid Alsherbini, MD
- Recruiting
Oregon Health & Science University
Portland, Oregon, 97239
Clinical Research Manager, 503-494-6233, fellersa@ohsu.edu
Ines Koerner, MD
- Recruiting
WakeMed
Raleigh, North Carolina, 27610
Research Coordinator, 919-350-7026, jcassels@wakemed.org
Travis Manasco
- Recruiting
UC Davis Medical Center
Sacramento, California, 95817
Trial Coordinator, 916-551-3234, savnguyen@ucdavis.edu
Jeffrey Vitt, MD
- Recruiting
University of Washington, Harborview
Seattle, Washington, 98104
Research Coordinator, 206-744-4634, ajames1@uw.edu
Abhijit Lele, MD
- Recruiting
Washington University Medical Center
St Louis, Missouri, 63110
Trial Coordinator, 3142732240, bfiori@wustl.edu
Omokhaye Higo, MD
- Recruiting
Stony Brook University Hospital
Stony Brook, New York, 11794
Trial Coordinator, 631-444-2970, Darcy.Halper@stonybrookmedicine.edu
Sofia Geralemou, MD
- Recruiting
Medstar Health
Washington D.C., District of Columbia, 20010
Trial Coordinator, 2028773519, mary.a.bellon@medstar.net
Jason Chang, MD
- Completed
Christiana Care
Wilmington, Delaware, 19899
About this study
Official 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
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.
Read the 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.
- Conditions
- Intracranial Pressure, Intracranial Pressure Changes, Traumatic Brain Injury, Intracerebral Hemorrhage, Encephalitis, Encephalopathy
- Keywords
- Intracranial Pressure, Traumatic Brain Injury, Cerebral Autoregulation
- Medical subject headings
- Brain Injuries, Traumatic, Cerebral Hemorrhage, Encephalitis, Brain Diseases, Hydrocephalus, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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 outcomes (4)
Demonstration that non-invasive ICP estimation using the CoMind One EFS device is insensitive to differences in skin tone across the population.
Measured: 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).
Measured: 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.
Measured: 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
Measured: From enrollment to the end of observation (either 3 weeks after removal of the CoMind device or until ICU discharge, whichever event is sooner)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2024
- Study start27 Nov 2024
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracranial PressureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 581 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CoMind Technologies Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Lindus Health
- Responsible party
- Sponsor
- Investigators
- Ramani Balu, MD, PhD, Principal investigator, Inova Fairfax Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06368648
- Sponsor's protocol ID
- CP-1
- Acronym
- CoMind EFS
- Status last verified
- Sep 2026
- First submitted
- 11 Apr 2024
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06368648
- Acronym / sponsor ID
- CoMind EFS / CP-1
- Conditions
- Intracranial Pressure, Intracranial Pressure Changes, Traumatic Brain Injury, Intracerebral Hemorrhage, Encephalitis, Encephalopathy
- Keywords
- Intracranial Pressure, Traumatic Brain Injury, Cerebral Autoregulation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 581 participants (estimated)
- Lead sponsor
- CoMind Technologies LimitedIndustry (pharma, biotech, devices)
- Collaborators
- Lindus Health
- Study start
- 27 Nov 2024 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 16 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
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.
4 secondary outcomes
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)
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)
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)
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ramani Balu, MD, PhD principal investigator
Inova Fairfax Hospital
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intracranial Pressure and Intracranial Pressure Changes, run by CoMind Technologies Limited at 17 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact David Diedo (305-290-1680, david@comind.io), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2026.