brain tumor stroke
Conditions
Interventions
None listed
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: - Adult (> 18 years) - Temporary or chronic bone defect in the skull (with a size of >50% of probe diameter), either with or without a plastic skull implant - Mentally competent to follow instructions during imaging
Exclusion criteria
Exclusion criteria: - Active infection of surrounding bone/plastic implant/brain tissue - Contra-indication to undergo fMRI-scan (due to e.g. an implant or claustrophobia) - Mental incompetence
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| As mentioned, the primary goal of this study is to compare and contrast the spatial and temporal patterns of fUS-defined functional areas with results acquired using fMRI. We will do so using two primary study parameters: 1) Spatial comparison between fUS- and fMRI- functional maps, using: a. the dice coefficient (DC): giving a value between [-1, 1], with -1 indicating *no agreement between the fUS- and fMRI-map* and 1 indicating *complete agreement between the fUS- and fMRI-map* b. the spatial correlation (SC): giving a value between [-1, 1], with -1 indicating *no agreement between the fUS- and fMRI-map* and 1 indicating *complete agreement between the fUS- and fMRI-map* c. the centre-of-mass error (CE): the outcome is a value in millimeters (mm) as a measure of discrepancy between the centre of mass of the fUS- vs. fMRI-defined functional maps. 2) Temporal comparison between fUS and fMRI, using: a. the rise-time difference (ΔRT): the outcome is a value in seconds, indicating the difference in average rise time between the average fUS- and fMRI-based functional signal b. the fall-time difference (ΔFT): the outcome is a value in seconds, indicating the difference in average fall time between the average fUS- and fMRI-based functional signal c. the difference in average ON-time (ΔO): the outcome is a value in seconds, indicating the difference in average ON-time between the average fUS- and fMRI-based functional signal d. the difference in average OFF-time (ΔO): the outcome is a value in seconds, indicating the difference in average OFF-time between the average fUS- and fMRI-based functional signal | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary study parameters involve: 1) the different imaging parameters that we wish to test in a systematic fashion to further optimize image quality and image acquisition for future studies. This endeavour is not statistical but will involve qualitative scoring of image quality and functional signal acquisition under different imaging parameters. 2) the extent of within-subject reproducibility of the image quality and functional signal in the same functional task and functional region. This is one of the main benefits of performing fUS in a SBD-setting as compared to the intra-operative setting, where time is very limited. We will compare image and signal quality in a qualitative manner across a maximum of 6 sessions, as a first-ever comparison of repeated in-human fUS-measurements. | — |
Countries
Netherlands
Outcome results
None listed