CoMind Early Feasibility Study (NCT06368648)
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
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: UC Davis Medical Center — Sacramento, California
Age range: 18 Years
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (15 Sites)
- UC Davis Medical Center — Sacramento, California
- Christiana Care — Wilmington, Delaware
- Medstar Health — Washington D.C., District of Columbia
- Jackson Memorial Hospital — Miami, Florida
- The University of Kansas Medical Center — Kansas City, Kansas
- Washington University Medical Center — St Louis, Missouri
- Albany Medical College — Albany, New York
- Stony Brook University Hospital — Stony Brook, New York
- WakeMed — Raleigh, North Carolina
- Ohio State University — Columbus, Ohio
- Oregon Health & Science University — Portland, Oregon
- University of Pennsylvania Hospital — Philadelphia, Pennsylvania
- Vanderbilt University Medical Center — Nashville, Tennessee
- Inova Fairfax Medical Campus — Falls Church, Virginia
- University of Washington, Harborview — Seattle, Washington
📞 Contact the Study Coordinator
Phone: (305) 290-1680
Email: david@comind.io
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.