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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03102983
Other study ID # 38RC16.026
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 6, 2016
Est. completion date December 2017

Study information

Verified date October 2018
Source University Hospital, Grenoble
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date December 2017
Est. primary completion date December 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 45 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
MRI functional
vowels records and MRI session

Locations

Country Name City State
France CHU Grenoble-Alpes Grenoble Isère

Sponsors (2)

Lead Sponsor Collaborator
University Hospital, Grenoble Gipsa-Lab, Département Parole et Cognition

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Evaluate the involvement of the speech motor system in the perception of vowels, using functional magnetic resonance imaging (fMRI). fMRI measured One hour and forty five minutes
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