Non-invasive Brain Pressure Monitoring for Brain Lesions
DW
AH
Overseen ByAmy Headlee, CCRP
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Trial Summary
What is the purpose of this trial?
The purpose of this research is to gather information on the safety and effectiveness of the Brain4Care device for measuring intracranial pressure without invasive procedures.
Research Team
AR
Alejandro Rabinstein, MD
Principal Investigator
Mayo Clinic
Eligibility Criteria
This trial is for adults with non-traumatic brain lesions at risk of increased pressure and herniation, who are in the Neuroscience ICU for monitoring. They should not be scheduled for immediate surgery. It's not open to minors or those unable to consent without a surrogate.Inclusion Criteria
You are an adult with a brain lesion that could cause swelling and potentially lead to dangerous brain shifts.
Patients admitted the Neuroscience ICU for serial neurological monitoring
Patients whose care is not expected to include immediate surgical decompression
Exclusion Criteria
Patients under the age of 18
Patients who are unable to provide consent due to neurologic deficit and does not have a surrogate decision maker available to provide consent
Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Monitoring
Participants are monitored using the Brain4Care device to measure intracranial pressure
3 months
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Treatment Details
Interventions
- Brain4Care device
Trial Overview The study tests the Brain4Care device's ability to measure intracranial pressure (ICP) safely and effectively without invasive methods, which could help monitor patients' conditions more comfortably.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: MonitoringExperimental Treatment1 Intervention
Imaging guided by monitoring results
Find a Clinic Near You
Who Is Running the Clinical Trial?
Mayo Clinic
Lead Sponsor
Trials
3,427
Recruited
3,221,000+
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