- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04547569
Somesthesic Role of the Ventro-lateral Prefrontal Cortex in Speech Motor Learning (BRAVA²)
May 31, 2022 updated by: University Hospital, Grenoble
Somesthesic Role of the Ventro-lateral Prefrontal Cortex in Speech Motor Learning fMRI Study
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
16
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
-
-
-
Grenoble, France, 38043
- CHU Grenoble-Alpes
-
-
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
18 years to 35 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
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: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Adaptation to altered auditory feedback
fMRI measurement of brain activity during speech production under altered auditory feedback
|
Sensorimotor adaptation in speech
fMRI measurement of brain activity
|
Experimental: Speech production
fMRI measurement of brain activity during normal speech production
|
fMRI measurement of brain activity
Speech production task
|
Experimental: Vibrotactile discrimination
fMRI measurement of brain activity during a vibrotactile discrimination task
|
fMRI measurement of brain activity
Vibrotactile Discrimination
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Performance as measured at the end of learning (during the 1h30 scanner session)
|
Brain activity
Time Frame: 1h30 scanner session
|
Brain activity are measure by the BOLD signal during both task-based and resting-state blocks
|
1h30 scanner session
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
October 20, 2020
Primary Completion (Actual)
July 6, 2021
Study Completion (Actual)
July 6, 2021
Study Registration Dates
First Submitted
September 7, 2020
First Submitted That Met QC Criteria
September 11, 2020
First Posted (Actual)
September 14, 2020
Study Record Updates
Last Update Posted (Actual)
June 1, 2022
Last Update Submitted That Met QC Criteria
May 31, 2022
Last Verified
May 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- 38RC18.173
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Motor Activity
-
Georgetown UniversityUniversity of PennsylvaniaCompletedPhysical Activity | Motor ActivityUnited States
-
University of North Carolina, Chapel HillNational Institute of Mental Health (NIMH)CompletedMotor Activity | Motor NeuroplasticityUnited States
-
Charles University, Czech RepublicRecruiting
-
Seattle Children's HospitalCompleted
-
Charles University, Czech RepublicActive, not recruiting
-
Riphah International UniversityCompleted
-
University of MichiganCompleted
-
University of TriesteCompleted
-
University Hospital, GrenobleUniversité Joseph Fourier; Centre National de la Recherche Scientifique, FranceCompleted
-
Rowe, Veronica, M.D.Completed
Clinical Trials on Speech adaptation
-
Dartmouth-Hitchcock Medical CenterMichael J. Fox Foundation for Parkinson's ResearchCompleted
-
University of Southern DenmarkCompletedSchizophreniaDenmark
-
Massachusetts Eye and Ear InfirmaryOregon Health and Science University; National Institute on Deafness and Other... and other collaboratorsEnrolling by invitationMigraine | Dizziness | Motion Sickness | Vestibular Migraine | Vestibular Schwannoma | Vestibular DisorderUnited States
-
Hospital de Clinicas de Porto AlegreCompletedOral Cancer | Intelligibility, Speech | Tongue Cancer | Jaw CancerBrazil
-
Idaho State UniversityNational Institute on Deafness and Other Communication Disorders (NIDCD)Active, not recruitingSpeech Sound DisorderUnited States
-
New York UniversityEmerson CollegeActive, not recruiting
-
New York UniversityEmerson CollegeActive, not recruitingAutism Spectrum DisorderUnited States
-
Université Catholique de LouvainCompletedCerebral PalsyBelgium
-
New York UniversityEmerson CollegeActive, not recruiting
-
The University of Texas Health Science Center at...National Institute of Mental Health (NIMH)Completed