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Realtime language mapping during awake brain surgery

Realtime language mapping during awake brain surgery - RELAY-study

Status
Unknown
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON50885
Enrollment
45
Registered
2021-05-18
Start date
2021-07-01
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

brain tumor glioma

Interventions

None listed

Sponsors

Erasmus MC, Universitair Medisch Centrum Rotterdam
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

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)

Design outcomes

Primary

MeasureTime frame
The main study parameter for fUS is the mean correlation value ('r'), also known as the Pearson Correlation Coefficient. For every administered task, the mean correlation between the task pattern and the Doppler signal is calculated along with the mean correlation calculated outside the functional area as a reference correlation value. The functional areas found by fUS, ESM, and (preoperative) fMRI will be compared. The percentage of similar brain areas found by two techniques is what we call an accuracy. We look at three accuracies (outcomes): the fUS-ESM accuracy, the fUS-fMRI accuracy and the fMRI-ESM accuracy.

Secondary

MeasureTime frame
The secundary outcome is the score on language tests. These scores will be compared to intraoperative mapping results (ESM and fUS) and fMRI results. Additionally, comparisons will be made between preoperative (preoperative language tests-preoperative fMRI) and postoperative (postoperative language tests-postoperative fMRI).

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Aug 9, 2026