Contribution of Functional MRI in Assessment of Auditory Processing Disorders

Study Overview
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Brief Summary
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Auditory Processing Disorder (APD) affects 0.5-7% of the pediatric population. This disorder is responsible for a child's low hearing ability. The diagnosis of APD is difficult because of polymorphic symptoms possibly entangled with other difficulties (learning, communication, attention ...). There is currently no gold standard in the literature for diagnosing APD. Investigators opened multidisciplinary consultation for the children suspected of APD. The purpose of this study is to analyze the results of the multidisciplinary assessment performed on these children (audiometry, cortical auditory brainstem response (ABR), behavioral assessment, psychometric evaluation, genetic analysis) to the results of functional MRI (fMRI) at rest and in activation. The goal is to find radiological MRI-fMRI markers in these patients that improve the diagnosis of APD. Investigators will compare the f-MRI results between three groups of children in order to find specific radiological markers of APD : group 1 : children diagnosed with an Auditory Processing Disorder (APD) group 2 : children suspect of APD group 3 : children without APD (controls)

Detailed Description
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The study will include a multidisciplinary consultation with: Targeted behavioral assessment auditory processing disorder (APD): speech-in-noise perception, phonemic identification and discrimination, dichotic listening test, temporal processing tests, Random Gap Detection Threshold (RGDT) test. Psychometric assessment: assessment of visual / auditory working memory, visual / auditory attention, study of cognitive functions. Ear, Nose, Throat (ENT) examination with otoscopy, tonal and vocal audiometry and ABR recording. Genetic analysis Cortical auditory evoked potential (AEP) recording, compared with the automatized cortical AEP recording on Hear Lab machine. The purpose of the study is looking for objective biomarkers of APD: Compare EEG results with MRI-fMRI results Analyze the cortical maturation of children who are fitted with hearings aids: second record of cortical APD performed one year after the fitting. Compare the results after one year between group 1 ( with or without hearing aids) and children from group 2. MRI-fMRI : to analyze the flow of perfusion, the DTI sequences, and the blood oxygen level-dependent (BOLD) effect (fMRI) With this multidisciplinary evaluation, the investigators wish to improve the diagnosis of APD in suspected children by associating clinical, radiological, electro-physiological and genetic criteria. Better understanding and more accurate diagnosis of APD's will improve the care management of these children.

Official Title
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Contribution of Functional MRI in Assessment of Auditory Processing Disorders

Conditions
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Auditory Processing Disorders

Intervention / Treatment
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* Diagnostic Test: functional MRI
* Diagnostic Test: Automated Cortical Brainstem Auditory Evoked Potential
* Genetic: whole exome sequencing
* Diagnostic Test: Standard Cortical Brainstem Auditory Evoked Potential
* Diagnostic Test: multidisciplinary consultation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Group 1 & 2: : 7 to 18 years old selected following multidisciplinary consultation whether the diagnosis is confirmed (group G1) or not (group G2). Signed consent of both parents Affiliated with a health insurance plan Inclusion Criteria Group 3: 7 to 18 years old do not present any known hearing pathology Signed consent of both parents Affiliated with a health insurance plan Exclusion Criteria: Require general anesthesia for MRI Contraindication to MRI Hearing aids for more than three months prior to inclusion in the study Require sedation specifically for research

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: confirmed auditory processing disorders<br>functional MRI, Cortical Brainstem Auditory Evoked Potential, Genetic | Diagnostic Test: functional MRI<br>* Additional sequence (DTI) and functional MRI (fMRI) during the MRI which is done as part of the usual care<br>Diagnostic Test: Automated Cortical Brainstem Auditory Evoked Potential<br>* Automated Cortical Brainstem Auditory Evoked Potential correspond to a non-invasive EEG<br>Genetic: whole exome sequencing<br>* A study of all the DNA-encoding exons of the child/parent from a sample taken as part of the usual care<br>|
| Experimental: suspected not confirmed auditory processing disorders<br>functional MRI, Cortical Brainstem Auditory Evoked Potential, Genetic | Diagnostic Test: functional MRI<br>* Additional sequence (DTI) and functional MRI (fMRI) during the MRI which is done as part of the usual care<br>Diagnostic Test: Automated Cortical Brainstem Auditory Evoked Potential<br>* Automated Cortical Brainstem Auditory Evoked Potential correspond to a non-invasive EEG<br>|
| Active Comparator: healthy volunteers<br>functional MRI, Cortical Brainstem Auditory Evoked Potential, Genetic, multidisciplinary consultation | Diagnostic Test: functional MRI<br>* Additional sequence (DTI) and functional MRI (fMRI) during the MRI which is done as part of the usual care<br>Diagnostic Test: Automated Cortical Brainstem Auditory Evoked Potential<br>* Automated Cortical Brainstem Auditory Evoked Potential correspond to a non-invasive EEG<br>Diagnostic Test: Standard Cortical Brainstem Auditory Evoked Potential<br>* Standard Cortical Brainstem Auditory Evoked Potential correspond to a non-invasive EEG<br>Diagnostic Test: multidisciplinary consultation<br>* multidisciplinary consultation is composed of: an ENT consultation and audiometry a speech therapy assessment a psychometric evaluation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BOLD effect | BOLD effect is measured during fMRI and compared between the 3 groups of patients | up to 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| set disyllabic words (Fournier or Boorsma lists) | Speech evaluation : set disyllabic words using the Fournier or Boorsma lists (the French equivalent of the. Peabody PBK test), depending on age | up to 4 weeks | 
| RapDys | Speech evaluation | up to 4 weeks | 
| Random Gap Detection Test (RGDT) | Speech evaluation | up to 4 weeks | 
| Dichotic listening test | Speech evaluation | up to 4 weeks | 
| temporal pattern recognition test | Speech evaluation | up to 4 weeks | 
| Test of Everyday Attention for Children (TEA-Ch test) | Psychometric evaluation for children aged 7-12 years | up to 4 weeks | 
| Wechsler Intelligence Scale for Children (WISC-V) test | Psychometric evaluation for children aged 13-18 years | up to 4 weeks | 
| Chromosomal analysis (group 1 only) | Genetic analysis | up to 12 months | 
| Work Environment Scale (WES) sequencing (group 1 only) | Genetic analysis | up to 12 months | 
| Measures of P1, N1, P2, N2 waves' Latencies | Cortical Brainstem Auditory Evoked | At inclusion day (visit 1) and at 12 months (group 1 and 2 only) | 
| Measures of P1, N1, P2, N2 waves' amplitudes | Cortical Brainstem Auditory Evoked | At inclusion day (visit 1) and at 12 months (group 1 an 2 only) | 
| Infusion Rate (MRI-ASL) | Infusion Rate (MRI-ASL) is measured during MRI | up to 4 weeks | 
| tractography results (DTI sequence) | tractography results (DTI sequence) is measured during MRI | up to 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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auditory processing disorders, functional MRI