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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03124173
Other study ID # 69HCL16_0684
Secondary ID
Status Completed
Phase N/A
First received March 9, 2017
Last updated January 17, 2018
Start date January 14, 2015
Est. completion date May 19, 2016

Study information

Verified date January 2018
Source Hospices Civils de Lyon
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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).


Recruitment information / eligibility

Status Completed
Enrollment 23
Est. completion date May 19, 2016
Est. primary completion date May 19, 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 45 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Training session
The subjects will be trained to realize several versions of a learning task of conditional visuo-motor associations.
First fMRI session
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 session
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 fMRI
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.

Locations

Country Name City State
France Hôpital Henri Mondor Creteil

Sponsors (1)

Lead Sponsor Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

References & Publications (1)

Hillis AE. Magnetic resonance perfusion imaging in the study of language. Brain Lang. 2007 Aug;102(2):165-75. Epub 2006 Jun 6. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
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