HealthyLANGUAGENCT03124173
Cognitive Control of Language
A study testing Training session, First fMRI session and Second fMRI session in people with Healthy, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
The cognitive control of speech is central to human social communication. Two frontal brain regions seem to have a critical role: 1) Broca's area (BA) and 2) the mid-cingulate cortex (MCC). Current rehabilitation strategy is clearly based on therapies promoting language performance. Read more about this study
- Who is it for?
- Ages 20 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Training session, First fMRI session and Second fMRI session
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteFrance
- Study dates
- 14 Jan 2015to 19 May 2016
- 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 20 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- being able to provide a written consent form
- having a social insurance
- have a normal vision (with or without corrections)
- Right-handed
Who cannot join
- Subjects with MRI contraindications (e.g. pacemaker, claustrophobia, metal in the body, etc…).
- Subjects must be willing to be advise in case of discovery of brain abnormality.
- History of known neurological or psychiatric illness
- Pregnant or nursing women
- Persons under guardianship, curators or any other administrative or judicial measure of deprivation of rights
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cognitive Control of Language and Frontal Cortex
The cognitive control of speech is central to human social communication. Two frontal brain regions seem to have a critical role: 1) Broca's area (BA) and 2) the mid-cingulate cortex (MCC). Current rehabilitation strategy is clearly based on therapies promoting language performance. However, there is few evidence that rehabilitation strategies based on nonlinguistic aspects of brain function may enhance recovery. Such strategies may benefit from knowledge about the primary -nonlinguistic- function of the BA-MCC network. The aim of LANGUAGE is to identify this primary function. One hypothesis is that, in non-speaking primates, this network is involved in cognitive control of voluntary vocal/orofacial production. Specifically, whereas BA may be responsible for the high-level selection of orofacial and vocal responses during learning, the face motor representation within the MCC may be responsible for performance monitoring, a process inherently required in learning. LANGUAGE aims to test this hypothesis by determining in human the anatomo-functional organization of the BA-MCC network thanks to functional magnetic resonance imaging (fMRI).
- Conditions
- Healthy
- Being tested
- Training session, First fMRI session, Second fMRI session, Third session of fMRI
- Keywords
- fMRI, cingulate cortex, adaptation, frontal cortex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Training sessionOther
The subjects will be trained to realize several versions of a learning task of conditional visuo-motor associations.
First fMRI sessionOther
In this session (involving a condition specific to man and a condition that we are certain to obtain in the monkey), subjects will have to learn by trial and error during successive trials, the conditional associations between three abstract stimuli and three Manual responses (3 MRI-compatible mouse buttons).
Second fMRI sessionOther
In this session (involving a condition specific to man and a condition that we are almost certain to obtain in monkeys), subjects will have to learn by trial and error during successive trials, the conditional associations between three abstract stimuli and Three orofacial responses (3 movements of the mouth).
Third session of fMRIOther
In this session (involving a human-specific condition and a condition we hope to achieve in the monkey), subjects will have to learn by trial-error in successive trials, conditional associations between three abstract stimuli and three verbal or Vocals.
| Study group | Role | What they receive |
|---|---|---|
| Behavioral Tasks | Other | Each subject will conduct 4 sessions, i.e. a training session and three fMRI sessions. The first session will consist in training the subject to carry out the different behavioral tasks that he will then have to perform during the sessions of fMRI. Receives: Other: Training session; Other: First fMRI session; Other: Second fMRI session; Other: Third session of fMRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Behavioral data: performance in the task
Performance in the task will be assessed. If performance in the task is <80%, subjects will be excluded in the final analysis
Measured: 3 years
fMRI data
BOLD signal will be analyzed in relation to the events of the task. Images must be not too much distorted to allow data analysis. As such, if a subject moved too much (translation>10mm; rotation>5°) the corresponding data will be excluded from the analysis.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2017
- Study start14 Jan 2015
- Primary completion19 May 2016
- Study completion19 May 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philippe Domenech, MD, Principal investigator, Henri Mondor University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03124173
- Sponsor's protocol ID
- 69HCL16_0684
- Acronym
- LANGUAGE
- Status last verified
- Sep 2025
- First submitted
- 9 Mar 2017
- Last updated
- 9 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hillis AE. Magnetic resonance perfusion imaging in the study of language. Brain Lang. 2007 Aug;102(2):165-75. doi: 10.1016/j.bandl.2006.04.016. Epub 2006 Jun 6.
PubMed 16757020Loh KK, Procyk E, Neveu R, Lamberton F, Hopkins WD, Petrides M, Amiez C. Cognitive control of orofacial motor and vocal responses in the ventrolateral and dorsomedial human frontal cortex. Proc Natl Acad Sci U S A. 2020 Mar 3;117(9):4994-5005. doi: 10.1073/pnas.1916459117. Epub 2020 Feb 14.
PubMed 32060124Loh KK, Hadj-Bouziane F, Petrides M, Procyk E, Amiez C. Rostro-Caudal Organization of Connectivity between Cingulate Motor Areas and Lateral Frontal Regions. Front Neurosci. 2018 Jan 11;11:753. doi: 10.3389/fnins.2017.00753. eCollection 2017.
PubMed 29375293
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Control of Language and Frontal Cortex
- ClinicalTrials.gov ID
- NCT03124173
- Acronym / sponsor ID
- LANGUAGE / 69HCL16_0684
- Conditions
- Healthy
- Keywords
- fMRI, cingulate cortex, adaptation, frontal cortex
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 14 Jan 2015 (actual)
- Primary completion
- 19 May 2016 (actual)
- Study completion
- 19 May 2016 (actual)
- First posted
- 21 Apr 2017 (actual)
- 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.
The cognitive control of speech is central to human social communication. Two frontal brain regions seem to have a critical role: 1) Broca's area (BA) and 2) the mid-cingulate cortex (MCC). Current rehabilitation strategy is clearly based on therapies promoting language performance. However, there is few evidence that rehabilitation strategies based on nonlinguistic aspects of brain function may enhance recovery. Such strategies may benefit from knowledge about the primary -nonlinguistic- function of the BA-MCC network. The aim of LANGUAGE is to identify this primary function. One hypothesis is that, in non-speaking primates, this network is involved in cognitive control of voluntary vocal/orofacial production. Specifically, whereas BA may be responsible for the high-level selection of orofacial and vocal responses during learning, the face motor representation within the MCC may be responsible for performance monitoring, a process inherently required in learning. LANGUAGE aims to test this hypothesis by determining in human the anatomo-functional organization of the BA-MCC network thanks to functional magnetic resonance imaging (fMRI).
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Behavioral Tasks | Other | Other: Training session, Other: First fMRI session, Other: Second fMRI session, Other: Third session of fMRIEach subject will conduct 4 sessions, i.e. a training session and three fMRI sessions. The first session will consist in training the subject to carry out the different behavioral tasks that he will then have to perform during the sessions of fMRI. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- being able to provide a written consent form
- having a social insurance
- have a normal vision (with or without corrections)
- Right-handed
Key exclusion criteria (5 listed)
- Subjects with MRI contraindications (e.g. pacemaker, claustrophobia, metal in the body, etc…).
- Subjects must be willing to be advise in case of discovery of brain abnormality.
- History of known neurological or psychiatric illness
- Pregnant or nursing women
- Persons under guardianship, curators or any other administrative or judicial measure of deprivation of rights
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 |
|---|---|---|
| Training sessionThe subjects will be trained to realize several versions of a learning task of conditional visuo-motor associations. | Other | Behavioral Tasks |
| First fMRI sessionIn this session (involving a condition specific to man and a condition that we are certain to obtain in the monkey), subjects will have to learn by trial and error during successive trials, the conditional associations between three abstract stimuli and three Manual responses (3 MRI-compatible mouse buttons). | Other | Behavioral Tasks |
| Second fMRI sessionIn this session (involving a condition specific to man and a condition that we are almost certain to obtain in monkeys), subjects will have to learn by trial and error during successive trials, the conditional associations between three abstract stimuli and Three orofacial responses (3 movements of the mouth). | Other | Behavioral Tasks |
| Third session of fMRIIn this session (involving a human-specific condition and a condition we hope to achieve in the monkey), subjects will have to learn by trial-error in successive trials, conditional associations between three abstract stimuli and three verbal or Vocals. | Other | Behavioral Tasks |
Primary outcome
Behavioral data: performance in the task
Time frame: 3 years
Performance in the task will be assessed. If performance in the task is <80%, subjects will be excluded in the final analysis
fMRI data
Time frame: 3 years
BOLD signal will be analyzed in relation to the events of the task. Images must be not too much distorted to allow data analysis. As such, if a subject moved too much (translation>10mm; rotation>5°) the corresponding data will be excluded from the analysis.
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 9 Sep 2025.
- Background: PubMed 16757020Hillis AE. Magnetic resonance perfusion imaging in the study of language. Brain Lang. 2007 Aug;102(2):165-75. doi: 10.1016/j.bandl.2006.04.016. Epub 2006 Jun 6.
- Results publication: PubMed 32060124Loh KK, Procyk E, Neveu R, Lamberton F, Hopkins WD, Petrides M, Amiez C. Cognitive control of orofacial motor and vocal responses in the ventrolateral and dorsomedial human frontal cortex. Proc Natl Acad Sci U S A. 2020 Mar 3;117(9):4994-5005. doi: 10.1073/pnas.1916459117. Epub 2020 Feb 14.
- Results publication: PubMed 29375293Loh KK, Hadj-Bouziane F, Petrides M, Procyk E, Amiez C. Rostro-Caudal Organization of Connectivity between Cingulate Motor Areas and Lateral Frontal Regions. Front Neurosci. 2018 Jan 11;11:753. doi: 10.3389/fnins.2017.00753. eCollection 2017.
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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.
Philippe Domenech, MD principal investigator
Henri Mondor University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Training session, First fMRI session and Second fMRI session in people with Healthy, run by Hospices Civils de Lyon 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 4 inclusion and 5 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 9 Sep 2025. 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?
Behavioral data: performance in the task (time frame: 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03124173, which also lists 3 linked publications.
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 9 Sep 2025.