Non-traumatic Hemispheric Brain Lesions
Conditions
Brief summary
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.
Interventions
DEVICENon-invasive bilateral monitoring of ICP waveform
Brain4care non-invasive bilateral monitoring of ICP waveform
Sponsors
Mayo Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patients with non-traumatic hemispheric brain lesions deemed at risk for progression of mass effect and possible subfalcine and/or uncal herniation. * 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. * Known or suspected Pregnancy * Adults with cranial defects or that have undergone craniectomy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Functional Outcome | 3 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Imaging Utilization | within ICU admission | Number of imaging scans |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAlejandro Rabinstein, MD
Mayo Clinic
Participant flow
Recruitment details
Recruitment stopped because bilateral monitoring was proven not sufficiently reliable for investigation
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 50 years STANDARD_DEVIATION 4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 6 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 5 Participants |
| Region of Enrollment United States | 6 participants |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 2 / 6 |
| other Total, other adverse events | 0 / 6 |
| serious Total, serious adverse events | 0 / 6 |
Outcome results
None listed