Neural Correlates of Language Control in Bilinguals. Functional MRI and Stimulation Mapping Data in Awake Surgery. (NEUROSWITCH)

March 25, 2018 updated by: University Hospital, Toulouse

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

Completed

Conditions

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Toulouse, France, 31059
        • University Hospital of Toulouse

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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 :

  • 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 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 :

  • In blocked vs. switched naming in the patients
  • In French vs. English and English vs. French naming in the late bilinguals
  • In French vs. English and English vs. French naming in the early bilinguals
  • In French vs. LX and LX vs. French naming in the patients.
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Vincent LUBRANO, MD, PhD, University Hospital, Toulouse

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2014

Primary Completion (Actual)

December 1, 2017

Study Completion (Actual)

December 1, 2017

Study Registration Dates

First Submitted

March 4, 2015

First Submitted That Met QC Criteria

March 17, 2015

First Posted (Estimate)

March 18, 2015

Study Record Updates

Last Update Posted (Actual)

March 27, 2018

Last Update Submitted That Met QC Criteria

March 25, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

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.

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