Clinical trial NCT02391493: Neural Correlates of Language Control in Bilinguals. Functional MRI and Stimulation Mapping Data in Awake Surgery.
Official title: Neural Correlates of Language Control in Bilinguals. Functional MRI and Stimulation Mapping Data in Awake Surgery. (NEUROSWITCH)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bilingualism
Keywords: bilinguals
language control
executive functions
functional MRI
stimulation mapping
brain tumors
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2015-03-18
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: For bilingual and multilingual patients, brain activation and Electric Stimulation Mapping studies have shown that different languages may be localized, at least partially, in distinct microanatomical systems located within the same gross anatomical areas.

The present investigation involves both types of healthy bilinguals with carefully controlled proficiency levels, as well as bilingual patients suffering from low-grade glioma.

Functional magnetic resonance imaging data will be collected while the participants perform a picture naming task in blocked conditions for both languages (either English or French) or in switch condition (English and French). A stimulation mapping study will be conducted in the patients during awake surgery with the same tasks.


Eligibility criteria: Inclusion Criteria:

Patients:

* Bilingual patients with a pathology indicating an intervention in awake surgery (e.g. low-grade glioma)
* At least C1-level of the CECR in both languages
* At least 12 years of schooling (French BAC)
* Right-handed (Edinburgh test, 1971)
* Performance indicator Eastern Cooperative Oncology Group 0-2 (cf. annexe)
* Life expectation \> 6 month
* Affiliated to social insurance
* Having given informed consent

Healthy volunteers:

* French-English or English-French bilinguals with at least a C1 level (CECR) in both languages
* At least 12 years of schooling (French BAC)
* Right-handed (Edinburgh test, 1971)
* Early bilinguals: age of acquisition of both languages \< 3 years
* Late bilinguals: age of acquisition of the L2 \> 10 years

Exclusion Criteria:

Patients:

* Contra-indication for MRI
* Left-handed or ambidexter (less than +80 at the Edinburgh test - 1971)
* Mini-Mental State Examination \<26
* Patient who cannot respect the procedures, visits, exams described in the protocol
* Any other medical or psychiatric affection which renders inclusion of the patient to the study inappropriate as judged by the principal investigator

Healthy volunteers:

* Contra-indication for MRI
* Mini-Mental State Examination \< 26
* Age of acquisition of one of the language between 3 and 10 years

Primary outcomes:
measure: Brain activity
timeFrame: 24 hours
Secondary outcomes:
measure: Brain activity
timeFrame: 24 hours
Other outcomes:
Locations:
city: Toulouse
country: France
facility: University Hospital of Toulouse
Study officials:
affiliation: University Hospital, Toulouse
name: Vincent LUBRANO, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: