Neural Correlates of Language Control in Bilinguals. Functional MRI and Stimulation Mapping Data in Awake Surgery.
NEUROSWITCH
2 other identifiers
interventional
24
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Nov 2014
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2014
CompletedFirst Submitted
Initial submission to the registry
March 4, 2015
CompletedFirst Posted
Study publicly available on registry
March 18, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedMarch 27, 2018
March 1, 2018
3.1 years
March 4, 2015
March 25, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Brain activity
The primary judgment criteria is brain activity as measured by functional magnetic resonance imaging : * In blocked vs. switched naming in control subjects * In switched naming in early vs. late bilingual subjects * In blocked vs. switched naming in early vs. late bilingual subjects
24 hours
Secondary Outcomes (1)
Brain activity
24 hours
Study Arms (3)
healthy early bilinguals
EXPERIMENTALhealthy early bilinguals functional magnetic resonance imaging
healthy late bilinguals
EXPERIMENTALhealthy late bilinguals functional magnetic resonance imaging
bilingual patients
EXPERIMENTALbilingual patients suffering from low-grade glioma in the language areas functional magnetic resonance imaging
Interventions
Stimuli will be presented in 3 language conditions, French, English and "switch" in which the participant alternates between English and French every trial. A block design will be used, with 7 line drawings per language condition. Four 9-minute runs will be performed, there being 2 action runs and 2 object runs. In each run, there are 6 blocks of each language condition, presented in a fixed random order. No drawings are repeated. Each stimulus is preceded either by an English or a French prompt word ("to" or "faire" for actions and, "say" or "dire" for objects) for 450 msec; stimuli are presented for 1.5 seconds and followed by a blank screen for 1 second. Language blocks are separated by a variable duration (from 8 to 10 seconds).
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- Healthy volunteers:
- Contra-indication for MRI
- Mini-Mental State Examination \< 26
- Age of acquisition of one of the language between 3 and 10 years
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital of Toulouse
Toulouse, 31059, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Vincent LUBRANO, MD, PhD
University Hospital, Toulouse
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 4, 2015
First Posted
March 18, 2015
Study Start
November 1, 2014
Primary Completion
December 1, 2017
Study Completion
December 1, 2017
Last Updated
March 27, 2018
Record last verified: 2018-03