An interventional study of Non-invasive bilateral monitoring of ICP waveform in Non-traumatic Hemispheric Brain Lesions, sponsored by Mayo Clinic. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-06.
Sponsored by Mayo Clinic · Not applicable, Interventional, and Health services research
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.
Mayo Clinic is the lead sponsor of 3,218 studies on the registry; 670 are open to participants now.
Of its 445 completed or terminated interventional studies of FDA-regulated products, 313 (70%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Imaging guided by monitoring results
Device: Non-invasive bilateral monitoring of ICP waveform
Brain4care non-invasive bilateral monitoring of ICP waveform
Functional Outcome
Functional outcome was assessed using the Modified Rankin Scale (mRS) which assesses functional outcomes in patients recovering from strokes. It consists of a 7-point ordinal scale ranging from 0 to 6 where 0=no symptoms and 6=dead with higher scores indicating a worse functional outcome.
Time frame: 3 months
Imaging Utilization
Number of imaging scans
Time frame: within ICU admission
Recruitment stopped because bilateral monitoring was proven not sufficiently reliable for investigation
| Milestone | Monitoring |
|---|---|
| Started | 6 |
| Completed | 3 |
| Not completed | 3 |
| Withdrew: Excessive signal feedback-uninterpretable data | 3 |
Functional outcome was assessed using the Modified Rankin Scale (mRS) which assesses functional outcomes in patients recovering from strokes. It consists of a 7-point ordinal scale ranging from 0 to 6 where 0=no symptoms and 6=dead with higher scores indicating a worse functional outcome.
| score on a scale | Monitoring |
|---|---|
| Functional Outcome | 3 (2 to 4) |
Number of imaging scans
No measurements were reported for this outcome.
Collected over Adverse events were collected from the time of informed consent through study completion, approximately 3 months.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Monitoring | 2/6 (33.3%) | 0/6 (0%) | 0/6 (0%) |
| Age, Continuous(years) | Monitoring |
|---|---|
| Mean | 50 ± 4 |
| Sex: Female, Male(Participants) | Monitoring |
|---|---|
| Female | 1 |
| Male | 5 |
| Ethnicity (NIH/OMB)(Participants) | Monitoring |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 6 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Monitoring |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 1 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 5 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Monitoring |
|---|---|
| United States | 6 |
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This study is terminated, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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