RecruitingNCT06368648

CoMind Early Feasibility Study

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


Sponsor

CoMind Technologies Limited

Enrollment

581 participants

Start Date

Nov 27, 2024

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a new treatment for people with autoregulation, encephalitis, and other related conditions. The study is currently recruiting participants at 14 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(14)

UC Davis Medical Center

Sacramento, California, United States

Christiana Care

Wilmington, Delaware, United States

Medstar Health

Washington D.C., District of Columbia, United States

Jackson Memorial Hospital

Miami, Florida, United States

The University of Kansas Medical Center

Kansas City, Kansas, United States

Washington University Medical Center

St Louis, Missouri, United States

Albany Medical College

Albany, New York, United States

Stony Brook University Hospital

Stony Brook, New York, United States

WakeMed

Raleigh, North Carolina, United States

Ohio State University

Columbus, Ohio, United States

University of Pennsylvania Hospital

Philadelphia, Pennsylvania, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Inova Fairfax Medical Campus

Falls Church, Virginia, United States

University of Washington, Harborview

Seattle, Washington, United States

View Full Details on ClinicalTrials.gov

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NCT06368648


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