- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02391493
Neural Correlates of Language Control in Bilinguals. Functional MRI and Stimulation Mapping Data in Awake Surgery. (NEUROSWITCH)
Neural Correlates of Language Control in Bilinguals. Functional MRI and Stimulation Mapping Data in Awake Surgery. (NEUROSWITCH)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Toulouse, France, 31059
- University Hospital of Toulouse
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: healthy early bilinguals
healthy early bilinguals functional magnetic resonance imaging
|
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).
|
|
Experimental: healthy late bilinguals
healthy late bilinguals functional magnetic resonance imaging
|
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).
|
|
Experimental: bilingual patients
bilingual patients suffering from low-grade glioma in the language areas functional magnetic resonance imaging
|
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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Brain activity
Time Frame: 24 hours
|
The primary judgment criteria is brain activity as measured by functional magnetic resonance imaging :
|
24 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Brain activity
Time Frame: 24 hours
|
The secondary judgment criteria is brain activity measured by functional magnetic resonance imaging :
|
24 hours
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Vincent LUBRANO, MD, PhD, University Hospital, Toulouse
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 13 245 03
- HAO 2013 (Other Identifier: Hors Appel d'Offres)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Bilingualism
-
Boston University Charles River CampusNational Institute on Deafness and Other Communication Disorders (NIDCD)RecruitingBilingualism | Vocabulary Acquisition | Late Talkers | Network ScienceUnited States
-
University of California, San FranciscoUniversity of California, Berkeley; The University of Hong Kong; National Institute... and other collaboratorsEnrolling by invitationEpilepsy | Brain Tumor | Bilingualism | SpeechUnited States
Clinical Trials on functional magnetic resonance imaging
-
University Hospital, GrenobleCompleted
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)CompletedGlioma | Brain MassUnited States
-
University of Texas Southwestern Medical CenterWithdrawn
-
Stanford UniversityCompletedAnorexia Nervosa | Obsessive-compulsive DisorderUnited States
-
Children's Hospital Medical Center, CincinnatiCompleted
-
Barcelonabeta Brain Research Center, Pasqual Maragall...Completed
-
Oregon Research InstituteNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Completed
-
Northwestern UniversityNational Center for Complementary and Integrative Health (NCCIH)Completed