HealthyNEUROPHONENCT03102983
Sensory-motor Interactions in the Perception of Vowels: a Study in Repetition - Suppression
A study testing MRI functional in people with Healthy, run by University Hospital, Grenoble at 1 site in France.
Trial summary
The aim of our study is to show by fMRI the involvement of the motor system in the perception of speech, and more particularly how this implication is modulated by the degree of prototypicity of the stimuli. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- MRI functional
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 6 Oct 2016to Dec 2017
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Medicall exam before MRI
- Pregnant Women
- Patients aged 18-45 years, Right-handed
- without neurologic and/or psychiatric troubles
- normal audition
- Audition normale
- French mother tongue
- Social security affiliation
Who cannot join
- protected person
- MRI contraindication
- claustrophobia
- respirtaory and cardiovascular pathology
- toxic substances taking
Trial locations and contacts
1 site in 1 country.
About this study
The aim of our study is to show by fMRI the involvement of the motor system in the perception of speech, and more particularly how this implication is modulated by the degree of prototypicity of the stimuli.
Read the detailed description
Each participant will undergo two visits:
Phase 1: The Gipsa-Lab Laboratory's Department of Speech and Cognition. This first visit will make it possible to make recordings of their vowel productions and to verify that the participants correspond to the criteria necessary for the study (passing the Edinburgh manual laterality test and auditory thresholds checked using a " An audiogram). It will also be an opportunity to provide them with the consent documents and the fact sheet, which will give them time to read it before the MRI exam. The duration of this first visit will be approximately 1 hour.
Phase 2: fMRI review in the 3Tesla MRI Unit at the Grenoble University Hospital Center. Participants will first undergo a medical examination in order to verify their absence of contraindication to the MRI examination. At the end of this medical examination, the consent of participation will be signed. The participants will then be able to carry out the MRI examination for a duration of about 1h15, then the behavioral judgment test of perceptual distance. The total duration of this second visit will be approximately 1h45.
- Conditions
- Healthy
- Being tested
- MRI functional
- Keywords
- MRI, Functional
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI functionalOther
vowels records and MRI session
| Study group | Role | What they receive |
|---|---|---|
| Healthy Volonteers | Experimental | Not described Receives: Other: MRI functional |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the involvement of the speech motor system in the perception of vowels, using functional magnetic resonance imaging (fMRI).
fMRI measured
Measured: One hour and forty five minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2017
- Study start6 Oct 2016
- Primary completionDec 2016
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Collaborators
- GIPSA-LAB
- Responsible party
- Sponsor
- Investigators
- Alexandre KRAINIK, PhD, Principal investigator, University Hospital, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03102983
- Sponsor's protocol ID
- 38RC16.026
- Acronym
- NEUROPHONE
- Status last verified
- Oct 2018
- First submitted
- 23 Mar 2017
- Last updated
- 10 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sensory-motor Interactions in the Perception of Vowels: a Study in Repetition - Suppression
- ClinicalTrials.gov ID
- NCT03102983
- Acronym / sponsor ID
- NEUROPHONE / 38RC16.026
- Conditions
- Healthy
- Keywords
- MRI, Functional
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Collaborators
- GIPSA-LAB
- Study start
- 6 Oct 2016 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 6 Apr 2017 (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.
The aim of our study is to show by fMRI the involvement of the motor system in the perception of speech, and more particularly how this implication is modulated by the degree of prototypicity of the stimuli.
Detailed description
Each participant will undergo two visits:
Phase 1: The Gipsa-Lab Laboratory's Department of Speech and Cognition. This first visit will make it possible to make recordings of their vowel productions and to verify that the participants correspond to the criteria necessary for the study (passing the Edinburgh manual laterality test and auditory thresholds checked using a " An audiogram). It will also be an opportunity to provide them with the consent documents and the fact sheet, which will give them time to read it before the MRI exam. The duration of this first visit will be approximately 1 hour.
Phase 2: fMRI review in the 3Tesla MRI Unit at the Grenoble University Hospital Center. Participants will first undergo a medical examination in order to verify their absence of contraindication to the MRI examination. At the end of this medical examination, the consent of participation will be signed. The participants will then be able to carry out the MRI examination for a duration of about 1h15, then the behavioral judgment test of perceptual distance. The total duration of this second visit will be approximately 1h45.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy Volonteers | Experimental | Other: MRI functional |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Medicall exam before MRI
- Pregnant Women
- Patients aged 18-45 years, Right-handed
- without neurologic and/or psychiatric troubles
- normal audition
Key exclusion criteria (5 listed)
- protected person
- MRI contraindication
- claustrophobia
- respirtaory and cardiovascular pathology
- toxic substances taking
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 |
|---|---|---|
| MRI functionalvowels records and MRI session | Other | Healthy Volonteers |
Primary outcome
Evaluate the involvement of the speech motor system in the perception of vowels, using functional magnetic resonance imaging (fMRI).
Time frame: One hour and forty five minutes
fMRI measured
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 10 Oct 2018.
- Individual participant dataSharing planned: No
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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.
Alexandre KRAINIK, PhD principal investigator
University Hospital, Grenoble
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRI functional in people with Healthy, 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 8 inclusion and 5 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 10 Oct 2018. 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?
Evaluate the involvement of the speech motor system in the perception of vowels, using functional magnetic resonance imaging (fMRI). (time frame: One hour and forty five minutes). 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 10 Oct 2018.