- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03124173
Cognitive Control of Language (LANGUAGE)
September 2, 2025 updated by: Hospices Civils de Lyon
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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
23
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
-
-
-
Créteil, France, 94000
- Hôpital Henri Mondor
-
-
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
20 years to 45 years (Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- being able to provide a written consent form
- having a social insurance
- have a normal vision (with or without corrections)
- Right-handed
Exclusion Criteria:
- 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
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: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Behavioral Tasks
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.
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The subjects will be trained to realize several versions of a learning task of conditional visuo-motor associations.
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).
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).
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
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3 years
|
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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.
|
3 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Philippe Domenech, MD, Henri Mondor University Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- Loh 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.
- Loh 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.
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 (Actual)
January 14, 2015
Primary Completion (Actual)
May 19, 2016
Study Completion (Actual)
May 19, 2016
Study Registration Dates
First Submitted
March 9, 2017
First Submitted That Met QC Criteria
April 20, 2017
First Posted (Actual)
April 21, 2017
Study Record Updates
Last Update Posted (Estimated)
September 9, 2025
Last Update Submitted That Met QC Criteria
September 2, 2025
Last Verified
September 1, 2025
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 69HCL16_0684
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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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