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NCT Number: NCT02391493

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

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.

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Key information

Conditions

Bilingualism Brain Diseases Brain Neoplasms Central Nervous System Diseases Central Nervous System Neoplasms Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital of Toulouse

Toulouse, 31059, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Functional Magnetic Resonance Imaging

Device

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).

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Official study title

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

Acronym: NEUROSWITCH

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Mar 18, 2015
Registry last updated
Mar 27, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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