| NCT ID | NCT06368648 |
| Status | Recruiting |
| Phase | — |
| Sponsor | CoMind Technologies Limited |
| Condition | Intracranial Pressure |
| Study Type | OBSERVATIONAL |
| Enrollment | 581 participants |
| Start Date | 2024-11-27 |
| Primary Completion | 2026-11 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 581 participants in total. It began in 2024-11-27 with a primary completion date of 2026-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Ramani Balu, MD, PhD
PRINCIPAL INVESTIGATOR
Inova Fairfax Hospital
Frequently Asked Questions
Who can join the NCT06368648 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Intracranial Pressure. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06368648 currently recruiting?
Yes, NCT06368648 is actively recruiting participants. Contact the research team at david@comind.io for enrollment information.
Where is the NCT06368648 trial being conducted?
This trial is being conducted at Sacramento, United States, Wilmington, United States, Washington D.C., United States, Miami, United States and 10 additional locations.
Who is sponsoring the NCT06368648 clinical trial?
NCT06368648 is sponsored by CoMind Technologies Limited. The principal investigator is Ramani Balu, MD, PhD at Inova Fairfax Hospital. The trial plans to enroll 581 participants.