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Somesthesic Role of the Ventro-lateral Prefrontal Cortex in Speech Motor Learning (BRAVA²)

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ClinicalTrials.gov Identifier: NCT04547569
Recruitment Status : Recruiting
First Posted : September 14, 2020
Last Update Posted : November 18, 2020
Sponsor:
Collaborators:
Laboratoire de Psychologie et NeuroCognition
GIPSA-LAB
McGill University
Information provided by (Responsible Party):
University Hospital, Grenoble

Study Description
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Brief Summary:
These studies test the hypothesis that frontal areas of the brain participate in the cortical networks involved in the somotosensory processing that happens during speech motor learning.

Condition or disease Intervention/treatment Phase
Speech Motor Activity Behavioral: Speech adaptation Behavioral: Vibrotactile Discrimination Other: fMRI Behavioral: Speech production Not Applicable

Detailed Description:
This work aims to study the role of sensory systems in human motor learning and specifically addresses the involvement of somatosensory cortical networks in motor learning of speech. Previous studies in the literature have highlighted the plasticity of cortical sensory networks, notably the primary and secondary somatosensory cortex and the ventral premotor cortex, during motor learning tasks. The present project focuses on the somatosensory region with connections to the sensorimotor regions of the frontal and parietal cortex. We propose to use neuroimaging (fMRI), in order to verify which areas in the prefrontal cortex are part of the sensorimotor network used in the learning of speech motor tasks in humans. Subjects will be tested in the fMRI scanner while performing either a behavioral task in which the auditory feedback of their own speech is altered or while performing a vibrotactile discrimination task.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Somesthesic Role of the Ventro-lateral Prefrontal Cortex in Speech Motor Learning fMRI Study
Actual Study Start Date : October 20, 2020
Estimated Primary Completion Date : September 2023
Estimated Study Completion Date : September 2023
Arms and Interventions
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Arm Intervention/treatment
Experimental: Adaptation to altered auditory feedback
fMRI measurement of brain activity during speech production under altered auditory feedback
 Behavioral: Speech adaptation
Sensorimotor adaptation in speech

Other: fMRI
fMRI measurement of brain activity
Experimental: Speech production
fMRI measurement of brain activity during normal speech production
 Other: fMRI
fMRI measurement of brain activity

Behavioral: Speech production
Speech production task
Experimental: Vibrotactile discrimination
fMRI measurement of brain activity during a vibrotactile discrimination task
 Behavioral: Vibrotactile Discrimination
Vibrotactile Discrimination

Other: fMRI
fMRI measurement of brain activity


Outcome Measures
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Primary Outcome Measures :
  1. Motor Learning [ Time Frame: Performance as measured at the end of learning (during the 1h30 scanner session) ]
    Learning is assessed as percentage change in speech sounds (speech formant frequencies) relative to baseline.

  2. Brain activity [ Time Frame: 1h30 scanner session ]
    Brain activity are measure by the BOLD signal during both task-based and resting-state blocks


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Right-handed subjects
  • Subjects fluent in French
  • Signed informed consent
  • Affiliation to or beneficiary of a Social Security scheme

Exclusion Criteria:

  • Left-handed subjects
  • Criteria for contraindications to protocol fMRI scans
  • Existence of a severe general condition: cardiac, respiratory, hematological, renal, hepatic, cancerous.
  • Hearing, language (including dyslexia), neurological or psychiatric disorders.
  • Participation in other ongoing intervention research protocols with exclusionary period or within the previous week
  • Drug treatment likely to modulate brain activity: benzodiazepines, antidepressants, neuroleptics, lithium, etc.

  • Protected persons referred to in articles L1121 5 to L1121 8 of the French CSP:

    • Pregnant women, parturients, nursing mothers,
    • Persons deprived of liberty by a judicial or administrative decision,
    • Persons under psychiatric care,
    • Individuals admitted to a health or social institution for purposes other than research,
    • Minors,
    • Persons over the age of majority who are subject to a legal protection measure or who are unable to express their consent
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04547569


Contacts
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Contact: Rafael LABOISSIERE, phD +33 4 76 82 59 26 rafael.laboissiere@univ-grenoble-alpes.fr

Locations
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France
CHU Grenoble-Alpes Recruiting
Grenoble, France, 38043
Contact: Rafael LABOISSIERE    +33476825926    rafael.laboissiere@univ-grenoble-alpes.fr   
Principal Investigator: Laurent VERCUEIL         
Sponsors and Collaborators
University Hospital, Grenoble
Laboratoire de Psychologie et NeuroCognition
GIPSA-LAB
McGill University
More Information
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Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT04547569    
Other Study ID Numbers: 38RC18.173
First Posted: September 14, 2020    Key Record Dates
Last Update Posted: November 18, 2020
Last Verified: November 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No