BilingualismNEUROSWITCHNCT02391493
Neural Correlates of Language Control in Bilinguals. Functional MRI and Stimulation Mapping Data in Awake Surgery.
A study testing functional magnetic resonance imaging in people with Bilingualism, run by University Hospital, Toulouse at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Bilingualism
- What is being tested?
- functional magnetic resonance imaging
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2014to Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
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- 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
Who cannot join
- 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
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- Healthy volunteers:
- Contra-indication for MRI
- Mini-Mental State Examination < 26
- Age of acquisition of one of the language between 3 and 10 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Bilingualism
- Being tested
- functional magnetic resonance imaging
- Keywords
- bilinguals, language control, executive functions, functional MRI, stimulation mapping, brain tumors
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
functional magnetic resonance imagingDevice
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).
| Study group | Role | What they receive |
|---|---|---|
| healthy early bilinguals | Experimental | healthy early bilinguals functional magnetic resonance imaging Receives: Device: functional magnetic resonance imaging |
| healthy late bilinguals | Experimental | healthy late bilinguals functional magnetic resonance imaging Receives: Device: functional magnetic resonance imaging |
| bilingual patients | Experimental | bilingual patients suffering from low-grade glioma in the language areas functional magnetic resonance imaging Receives: Device: functional magnetic resonance imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 24 hours
Secondary outcomes (1)
Brain activity
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.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2015 (estimated)
- Study startNov 2014
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BilingualismStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vincent LUBRANO, MD, PhD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02391493
- Sponsor's protocol ID
- 13 245 03
- Other IDs
- HAO 2013
- Acronym
- NEUROSWITCH
- Status last verified
- Mar 2018
- First submitted
- 4 Mar 2015
- Last updated
- 27 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neural Correlates of Language Control in Bilinguals. Functional MRI and Stimulation Mapping Data in Awake Surgery. (NEUROSWITCH)
- ClinicalTrials.gov ID
- NCT02391493
- Acronym / sponsor ID
- NEUROSWITCH / 13 245 03
- Conditions
- Bilingualism
- Keywords
- bilinguals, language control, executive functions, functional MRI, stimulation mapping, brain tumors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 18 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| healthy early bilinguals | Experimental | Device: functional magnetic resonance imaginghealthy early bilinguals functional magnetic resonance imaging |
| healthy late bilinguals | Experimental | Device: functional magnetic resonance imaginghealthy late bilinguals functional magnetic resonance imaging |
| bilingual patients | Experimental | Device: functional magnetic resonance imagingbilingual patients suffering from low-grade glioma in the language areas functional magnetic resonance imaging |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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)
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| functional magnetic resonance imagingStimuli 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). | Device | bilingual patients, healthy early bilinguals, healthy late bilinguals |
Primary outcome
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
1 secondary outcome
Brain activity
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vincent LUBRANO, MD, PhD principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing functional magnetic resonance imaging in people with Bilingualism, run by University Hospital, Toulouse at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brain activity (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2018.