- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03094624
Auditory Deficits in Congenital Amusia (AMUSIE CONGENITALE)
Auditory Perceptual and Memory Deficits in Congenital Amusia: Studies of Cerebral Correlates With MEG, Anatomical MRI and Functional MRI
The project studies auditory deficits in congenital amusia at the behavioral and neurophysiological levels.
The auditory processes investigated are pitch discrimination, short-term memory, sound-induced emotions. To characterize auditory deficits in the amusic population, neuropsychological assessments are combined with neurophysiological markers (Electro-encephalography: EEG, Magneto-encephalography: MEG, Magnetic Resonance Imaging: MRI).
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Lyon, France, 69003
- Hospices Civils de Lyon, Hôpital Edouard Herriot
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Aged from 18 to 70 years' old
- French
- Compatibility IRM / MEG (no metal in the body)
- Motivation to participate effectively in the project
- No neurological or psychiatric history
- No severe hearing loss
- Informed consent to participate in the study
- For Amusic participants: participant diagnosed amusic by the MBEA (Montreal Battery of Evaluation of Amusia)
- For Control participants: matched in age, sex, education, music education, laterality, non-amusic (controlled with the MBEA)
Exclusion Criteria:
- Age below 18 or above 70
- Non-Francophone volunteers.
- MRI scanning not possible: artificial cardiac pacemaker, insulin pump, metallic prosthesis, intra-cerebral clip, claustrophobia
- MEG acquisition not possible: large heads, neurostimulator, metal in the head or the body.
- Pregnant or breast-feeding women
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Amusia
Since 2006, recruitment of amusia participants has been organized in the Lyon region, and some 20 participants (and their matched controls in terms of age, sex, laterality, musical practice, number of years of study) have already taken part various studies conducted at the CRNL.
The recruitment of amusia participants and controls is continued in order to maintain a sufficient number of participants and compensate for the withdrawals within the cohort already constituted (lack of availability, geographical distance, etc.).
|
Neuropsychological tests consist in listening to sounds in various contexts and providing behavioral responses with response-buttons.
Neurophysiological tests consist in the recording of EEG and/or MEG signals or MRI images while realizing the neuropsychological tests, as well as anatomical MRI scanning to characterize the participants' brain anatomy and reconstruct the brain sources of surface EEG/MEG signals.
Experiment 1 are interested in perception and musical memory vs. Language and contribute to our understanding of the functional and structural organization of the brain to perceive and memorize music and language.
Experiment 2 focuses on perception and musical memory vs. Language and contribute to our understanding of the functional and structural organization of the brain to perceive and memorize music and language.
The second experiment will also study short-term memory networks for musical and verbal materials, but the specificity will be the inclusion of a verbal material sung, thus representing the combination of both information.
Experiment 2 is divided into two sub-parts.
Indeed, the investigators will develop the musical and verbal materials during a first experimental part in experiment (experiment 2a) and then apply them in experimentation MEG (experiment 2b).
Experiment 2a will allow us to test new equipment in a short term memory task under conditions that are less restrictive for the participants.
Then the investigators will apply the optimal material that emerges for the MEG experiment.
Experiment 3 will use Discordant Negativity (MMN; Mismatch Negativity) protocols in coupled EEG-MEG (experiment 3a) and EEG alone (experiment 3b) to investigate memory traces of sensory information.
The MMN is used to probe auditory sensory memory (pre-requisite for short- or long-term storage), and has the advantage of being measured without requiring an active task from the participant.
Experiment 4 will study the neural correlates of long-term memory for musical and verbal material with fMRI.
The testimonies of the amusicians suggest a deficit of the "musical lexicon" which contrasts with that the musical lexicon elaborated of the non-musician listeners.
|
|
Sham Comparator: Matched controls
Matched controls of age, sex, laterality, musical practice, number of years of studies.
|
Neuropsychological tests consist in listening to sounds in various contexts and providing behavioral responses with response-buttons.
Neurophysiological tests consist in the recording of EEG and/or MEG signals or MRI images while realizing the neuropsychological tests, as well as anatomical MRI scanning to characterize the participants' brain anatomy and reconstruct the brain sources of surface EEG/MEG signals.
Experiment 1 are interested in perception and musical memory vs. Language and contribute to our understanding of the functional and structural organization of the brain to perceive and memorize music and language.
Experiment 2 focuses on perception and musical memory vs. Language and contribute to our understanding of the functional and structural organization of the brain to perceive and memorize music and language.
The second experiment will also study short-term memory networks for musical and verbal materials, but the specificity will be the inclusion of a verbal material sung, thus representing the combination of both information.
Experiment 2 is divided into two sub-parts.
Indeed, the investigators will develop the musical and verbal materials during a first experimental part in experiment (experiment 2a) and then apply them in experimentation MEG (experiment 2b).
Experiment 2a will allow us to test new equipment in a short term memory task under conditions that are less restrictive for the participants.
Then the investigators will apply the optimal material that emerges for the MEG experiment.
Experiment 3 will use Discordant Negativity (MMN; Mismatch Negativity) protocols in coupled EEG-MEG (experiment 3a) and EEG alone (experiment 3b) to investigate memory traces of sensory information.
The MMN is used to probe auditory sensory memory (pre-requisite for short- or long-term storage), and has the advantage of being measured without requiring an active task from the participant.
Experiment 4 will study the neural correlates of long-term memory for musical and verbal material with fMRI.
The testimonies of the amusicians suggest a deficit of the "musical lexicon" which contrasts with that the musical lexicon elaborated of the non-musician listeners.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Correct answers to the neuropsychological tests
Time Frame: Day 1
|
Percentages of correct responses
|
Day 1
|
|
Neuropsychological tests reaction times
Time Frame: Day 1
|
Neuropsychological tests reaction times
|
Day 1
|
|
Neurophysiological tests EEG
Time Frame: Day 1
|
Event-Related Potentials (EEG)
|
Day 1
|
|
Neurophysiological tests MEG
Time Frame: Day 1
|
Event-Related Fields (MEG)
|
Day 1
|
|
Neurophysiological tests MRI
Time Frame: Day 1
|
MRI images
|
Day 1
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Julien JUNG, MD, Hospices Civils de Lyon
Publications and helpful links
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 (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 69HCL16_0662
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
product manufactured in and exported from the U.S.
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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