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Device sensitive issues
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Monitoring | Experimental | Imaging guided by monitoring results |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-invasive bilateral monitoring of ICP waveform | Device | Brain4care non-invasive bilateral monitoring of ICP waveform |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Imaging Utilization | Number of imaging scans | within ICU admission |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alejandro Rabinstein, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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Recruitment stopped because bilateral monitoring was proven not sufficiently reliable for investigation
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| ID | Title | Description |
|---|---|---|
| FG000 | Monitoring | Imaging guided by monitoring results Non-invasive bilateral monitoring of ICP waveform: Brain4care non-invasive bilateral monitoring of ICP waveform |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Monitoring | Imaging guided by monitoring results Non-invasive bilateral monitoring of ICP waveform: Brain4care non-invasive bilateral monitoring of ICP waveform |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 1 patient was unable to be reached for follow up | Posted | Mean | Inter-Quartile Range | score on a scale | 3 months |
|
|
Adverse events were collected from the time of informed consent through study completion, approximately 3 months.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Monitoring | Imaging guided by monitoring results Non-invasive bilateral monitoring of ICP waveform: Brain4care non-invasive bilateral monitoring of ICP waveform |
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The study was terminated early as there were issues with the sensitive of the device.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alejandro Rabinstein, M.D. | Mayo Clinic | 507-284-4741 | Rabinstein.Alejandro@mayo.edu |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 6, 2021 | Nov 5, 2025 | Prot_000.pdf |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Participants |
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| Secondary | Imaging Utilization | Number of imaging scans | The BrainCare device was too sensitive to any movement including breathing. Due to the sensitivity of the device, zero ICP waveforms were detected. The waveforms were needed to measure this outcome, with the waveforms not showing up on the BrainCare device due to the sensitivity of the device, this outcome could not be measured. | Posted | within ICU admission |
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| 2 |
| 6 |
| 0 |
| 6 |
| 0 |
| 6 |
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