CoMind Early Feasibility Study

Part of paid clinical trials in Sacramento, California.

Sponsor
CoMind Technologies Limited
Study ID
NCT06368648
Status
Recruiting
Apply to this trial

Conditions

  • Autoregulation
  • Encephalitis
  • Encephalopathy
  • Hydrocephalus
  • Intracerebral Hemorrhage
  • Intracranial Pressure
  • Intracranial Pressure Changes
  • Stroke
  • Traumatic Brain Injury

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Study Details

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.

Key Dates

Start date
Nov 27, 2024
Status verified
Oct 2025
Primary completion
Nov 30, 2026
Completion
Nov 30, 2026

Study Design

Enrollment
581 participants (estimated)

Arms

  • Arm: 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) ]

Central Contacts

Locations (14)

FacilityCityStateZIPSite coordinators
UC Davis Medical CenterSacramentoCalifornia95817
Trial Coordinator
[email protected]
916-551-3234
Jeffrey Vitt, MD (PRINCIPAL_INVESTIGATOR)
Christiana CareWilmingtonDelaware19899-
Medstar HealthWashington D.C.District of Columbia20010
Trial Coordinator
[email protected]
2028773519
Jason Chang, MD (PRINCIPAL_INVESTIGATOR)
Jackson Memorial HospitalMiamiFlorida33136
Trial Coordinator
[email protected]
305-243-3056
Jonathan Jagid, MD (PRINCIPAL_INVESTIGATOR)
The University of Kansas Medical CenterKansas CityKansas66103-
Washington University Medical CenterSt LouisMissouri63110
Trial Coordinator
[email protected]
3142732240
Omokhaye Higo, MD (PRINCIPAL_INVESTIGATOR)
Albany Medical CollegeAlbanyNew York12208-
Stony Brook University HospitalStony BrookNew York11794
Trial Coordinator
[email protected]
631-444-2970
Sofia Geralemou, MD (PRINCIPAL_INVESTIGATOR)
WakeMedRaleighNorth Carolina27610
Research Coordinator
[email protected]
919-350-7026
Ohio State UniversityColumbusOhio43210
Research Coordinator
[email protected]
(614) 293-3559
Andrew Springer, MD (PRINCIPAL_INVESTIGATOR)
University of Pennsylvania HospitalPhiladelphiaPennsylvania19104
Trial Coordinator
[email protected]
267-254-4745
Danielle Sandsmark, MD, PHD (PRINCIPAL_INVESTIGATOR)
Vanderbilt University Medical CenterNashvilleTennessee37232
Research Nurse Specialist
[email protected]
615-875-1969
Christopher Hughes, MD (PRINCIPAL_INVESTIGATOR)
Inova Fairfax Medical CampusFalls ChurchVirginia22042-
University of Washington, HarborviewSeattleWashington98104
Research Coordinator
[email protected]
206-744-4634
Abhijit Lele, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Sacramento, CA

By condition
Stroke
By specialty
NeurologyBrain disorders
By research site
UC Davis Medical Center· Sacramento, CAChristiana Care· Wilmington, DEMedstar Health· Washington D.C., DCJackson Memorial Hospital· Miami, FLThe University of Kansas Medical Center· Kansas City, KSWashington University Medical Center· St Louis, MO

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