Non-traumatic Hemispheric Brain Lesions Clinical Trial
Official title:
Early Non-invasive Detection of Progression of Mass Effect From Unilateral Brain Lesions
| Verified date | April 2024 |
| Source | Mayo Clinic |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Enrolling by invitation |
| Enrollment | 20 |
| Est. completion date | January 2025 |
| Est. primary completion date | January 2025 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| United States | Mayo Clinic in Rochester | Rochester | Minnesota |
| Lead Sponsor | Collaborator |
|---|---|
| Mayo Clinic |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Functional outcome | modified Rankin score | 3 months | |
| Secondary | Imaging utilization | Number of imaging scans | within ICU admission |