NCT02391493

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 4, 2015

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 18, 2015

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

March 27, 2018

Status Verified

March 1, 2018

Enrollment Period

3.1 years

First QC Date

March 4, 2015

Last Update Submit

March 25, 2018

Conditions

Keywords

bilingualslanguage controlexecutive functionsfunctional MRIstimulation mappingbrain tumors

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

EXPERIMENTAL

healthy early bilinguals functional magnetic resonance imaging

Device: functional magnetic resonance imaging

healthy late bilinguals

EXPERIMENTAL

healthy late bilinguals functional magnetic resonance imaging

Device: functional magnetic resonance imaging

bilingual patients

EXPERIMENTAL

bilingual patients suffering from low-grade glioma in the language areas functional magnetic resonance imaging

Device: 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).

bilingual patientshealthy early bilingualshealthy late bilinguals

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

MeSH Terms

Conditions

Brain Neoplasms

Interventions

Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Central Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

TomographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Vincent LUBRANO, MD, PhD

    University Hospital, Toulouse

    PRINCIPAL INVESTIGATOR

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

Locations