Trial Outcomes & Findings for A Study to Detect Progression of Mass Effect From Unilateral Brain Lesions (NCT NCT04745884)
NCT ID: NCT04745884
Last Updated: 2026-02-06
Results Overview
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.
TERMINATED
NA
6 participants
3 months
2026-02-06
Participant Flow
Recruitment stopped because bilateral monitoring was proven not sufficiently reliable for investigation
Participant milestones
| Measure |
Monitoring
Imaging guided by monitoring results
Non-invasive bilateral monitoring of ICP waveform: Brain4care non-invasive bilateral monitoring of ICP waveform
|
|---|---|
|
Overall Study
STARTED
|
6
|
|
Overall Study
COMPLETED
|
3
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Monitoring
Imaging guided by monitoring results
Non-invasive bilateral monitoring of ICP waveform: Brain4care non-invasive bilateral monitoring of ICP waveform
|
|---|---|
|
Overall Study
Excessive Signal Feedback-Uninterpretable Data
|
3
|
Baseline Characteristics
A Study to Detect Progression of Mass Effect From Unilateral Brain Lesions
Baseline characteristics by cohort
| Measure |
Monitoring
n=6 Participants
Imaging guided by monitoring results
Non-invasive bilateral monitoring of ICP waveform: Brain4care non-invasive bilateral monitoring of ICP waveform
|
|---|---|
|
Region of Enrollment
United States
|
6 participants
n=41 Participants
|
|
Age, Continuous
|
50 years
STANDARD_DEVIATION 4 • n=41 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=41 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=41 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=41 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=41 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=41 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=41 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=41 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=41 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=41 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=41 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=41 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=41 Participants
|
PRIMARY outcome
Timeframe: 3 monthsPopulation: 1 patient was unable to be reached for follow up
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.
Outcome measures
| Measure |
Monitoring
n=5 Participants
Imaging guided by monitoring results
Non-invasive bilateral monitoring of ICP waveform: Brain4care non-invasive bilateral monitoring of ICP waveform
|
|---|---|
|
Functional Outcome
|
3 score on a scale
Interval 2.0 to 4.0
|
SECONDARY outcome
Timeframe: within ICU admissionPopulation: 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.
Number of imaging scans
Outcome measures
Outcome data not reported
Adverse Events
Monitoring
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place