SpeechBRAVA²NCT04547569
Somesthesic Role of the Ventro-lateral Prefrontal Cortex in Speech Motor Learning
A study testing Speech adaptation, Vibrotactile Discrimination and fMRI in people with Speech and Motor Activity, run by University Hospital, Grenoble at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Speech, Motor Activity
- What is being tested?
- Speech adaptation, Vibrotactile Discrimination and fMRI
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteFrance
- Study dates
- 20 Oct 2020to 6 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Right-handed subjects
- Subjects fluent in French
- Signed informed consent
- Affiliation to or beneficiary of a Social Security scheme
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Speech, Motor Activity
- Being tested
- Speech adaptation, Vibrotactile Discrimination, fMRI, Speech production
- Medical subject headings
- Speech, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Speech adaptationBehavioural
Sensorimotor adaptation in speech
Vibrotactile DiscriminationBehavioural
Vibrotactile Discrimination
fMRIOther
fMRI measurement of brain activity
Speech productionBehavioural
Speech production task
| Study group | Role | What they receive |
|---|---|---|
| Adaptation to altered auditory feedback | Experimental | fMRI measurement of brain activity during speech production under altered auditory feedback Receives: Behavioral: Speech adaptation; Other: fMRI |
| Speech production | Experimental | fMRI measurement of brain activity during normal speech production Receives: Other: fMRI; Behavioral: Speech production |
| Vibrotactile discrimination | Experimental | fMRI measurement of brain activity during a vibrotactile discrimination task Receives: Behavioral: Vibrotactile Discrimination; Other: fMRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Motor Learning
Learning is assessed as percentage change in speech sounds (speech formant frequencies) relative to baseline.
Measured: Performance as measured at the end of learning (during the 1h30 scanner session)
Brain activity
Brain activity are measure by the BOLD signal during both task-based and resting-state blocks
Measured: 1h30 scanner session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2020
- Study start20 Oct 2020
- Primary completion6 Jul 2021
- Study completion6 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SpeechStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Collaborators
- Laboratoire de Psychologie et NeuroCognition, GIPSA-LAB, McGill University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04547569
- Sponsor's protocol ID
- 38RC18.173
- Acronym
- BRAVA²
- Status last verified
- May 2022
- First submitted
- 7 Sep 2020
- Last updated
- 1 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Somesthesic Role of the Ventro-lateral Prefrontal Cortex in Speech Motor Learning fMRI Study
- ClinicalTrials.gov ID
- NCT04547569
- Acronym / sponsor ID
- BRAVA² / 38RC18.173
- Conditions
- Speech, Motor Activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Collaborators
- Laboratoire de Psychologie et NeuroCognition, GIPSA-LAB, McGill University
- Study start
- 20 Oct 2020 (actual)
- Primary completion
- 6 Jul 2021 (actual)
- Study completion
- 6 Jul 2021 (actual)
- First posted
- 14 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Adaptation to altered auditory feedback | Experimental | Behavioral: Speech adaptation, Other: fMRIfMRI measurement of brain activity during speech production under altered auditory feedback |
| Speech production | Experimental | Other: fMRI, Behavioral: Speech productionfMRI measurement of brain activity during normal speech production |
| Vibrotactile discrimination | Experimental | Behavioral: Vibrotactile Discrimination, Other: fMRIfMRI measurement of brain activity during a vibrotactile discrimination task |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Right-handed subjects
- Subjects fluent in French
- Signed informed consent
- Affiliation to or beneficiary of a Social Security scheme
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Speech adaptationSensorimotor adaptation in speech | Behavioural | Adaptation to altered auditory feedback |
| Vibrotactile DiscriminationVibrotactile Discrimination | Behavioural | Vibrotactile discrimination |
| fMRIfMRI measurement of brain activity | Other | Adaptation to altered auditory feedback, Speech production, Vibrotactile discrimination |
| Speech productionSpeech production task | Behavioural | Speech production |
Primary outcome
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.
Brain activity
Time frame: 1h30 scanner session
Brain activity are measure by the BOLD signal during both task-based and resting-state blocks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Speech adaptation, Vibrotactile Discrimination and fMRI in people with Speech and Motor Activity, run by University Hospital, Grenoble at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Motor Learning (time frame: Performance as measured at the end of learning (during the 1h30 scanner session)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2022.