NCT03124173

Brief 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. 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).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
23

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Jan 2015

Typical duration for not_applicable healthy

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 14, 2015

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 19, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 19, 2016

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

March 9, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 21, 2017

Completed
Last Updated

September 9, 2025

Status Verified

September 1, 2025

Enrollment Period

1.3 years

First QC Date

March 9, 2017

Last Update Submit

September 2, 2025

Conditions

Keywords

fMRIcingulate cortexadaptationfrontal cortex

Outcome Measures

Primary Outcomes (2)

  • 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

    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.

    3 years

Study Arms (1)

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.

Other: Training sessionOther: First fMRI sessionOther: Second fMRI sessionOther: Third session of fMRI

Interventions

The subjects will be trained to realize several versions of a learning task of conditional visuo-motor associations.

Behavioral Tasks

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).

Behavioral Tasks

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).

Behavioral Tasks

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.

Behavioral Tasks

Eligibility Criteria

Age20 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • being able to provide a written consent form
  • having a social insurance
  • have a normal vision (with or without corrections)
  • Right-handed

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Henri Mondor

Créteil, 94000, France

Location

Related Publications (3)

  • 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.

    PMID: 32060124BACKGROUND
  • 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.

    PMID: 29375293BACKGROUND
  • 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.

    PMID: 16757020BACKGROUND

Study Officials

  • Philippe Domenech, MD

    Henri Mondor University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 9, 2017

First Posted

April 21, 2017

Study Start

January 14, 2015

Primary Completion

May 19, 2016

Study Completion

May 19, 2016

Last Updated

September 9, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations