- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03102983
Sensory-motor Interactions in the Perception of Vowels: a Study in Repetition - Suppression (NEUROPHONE)
Study Overview
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Isère
-
Grenoble, Isère, France, 38043
- CHU Grenoble-Alpes
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- protected person
- MRI contraindication
- claustrophobia
- respirtaory and cardiovascular pathology
- toxic substances taking
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Healthy Volonteers
|
vowels records and MRI session
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
One hour and forty five minutes
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Alexandre KRAINIK, PhD, University Hospital, Grenoble
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 38RC16.026
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
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