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Realtime language mapping during awake brain surgery

Conditions
brain tumor
glioma
10029211
10009720
Registration Number
NL-OMON50885
Lead Sponsor
Erasmus MC, Universitair Medisch Centrum Rotterdam
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Pending
Sex
Not specified
Target Recruitment
45
Inclusion Criteria

- Undergoing awake craniotomy for the indication of glioma removal with ESM
(electrical stimulation mapping) already planned for the removal of the tumor
- Age >= 18 years
- Mentally competent
- Location of the tumor in or near a functional area (e.g. language, motor)
- Informed written consent

Exclusion Criteria

- Depression or an anxiety disorder
- Inadequate level of Dutch
- History of a medical, neurological or psychiatric condition known to affect
language or cognitive functioning
-(History of) substance abuse
-Use of medication known to influence language or cognitive functioning (other
than anti-epileptic drugs)

Study & Design

Study Type
Observational non invasive
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>The main study parameter for fUS is the mean correlation value ('r'), also<br /><br>known as the Pearson Correlation Coefficient. For every administered task, the<br /><br>mean correlation between the task pattern and the Doppler signal is calculated<br /><br>along with the mean correlation calculated outside<br /><br>the functional area as a reference correlation value. The functional areas<br /><br>found by fUS, ESM, and (preoperative) fMRI will be compared. The percentage of<br /><br>similar brain areas found by two techniques is what we call an accuracy. We<br /><br>look at three accuracies (outcomes): the fUS-ESM accuracy, the fUS-fMRI<br /><br>accuracy and the fMRI-ESM accuracy. </p><br>
Secondary Outcome Measures
NameTimeMethod
<p>The secundary outcome is the score on language tests. These scores will be<br /><br>compared to intraoperative mapping results (ESM and fUS) and fMRI results.<br /><br>Additionally, comparisons will be made between preoperative (preoperative<br /><br>language tests-preoperative fMRI) and postoperative (postoperative language<br /><br>tests-postoperative fMRI).</p><br>
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