Contribution of Functional MRI in Assessment of Auditory Processing Disorders (IRMf-TTA)

Assistance Publique - Hôpitaux de Paris

Status: Active, not recruiting

Conditions: Auditory Processing Disorders

Treatments: Genetic: whole exome sequencing; Diagnostic Test: multidisciplinary consultation; Diagnostic Test: functional MRI; Diagnostic Test: Automated Cortical Brainstem Auditory Evoked Potential; Diagnostic Test: Standard Cortical Brainstem Auditory Evoked Potential

Study type: Interventional

Funder types: Other

Identifiers

NCT03887182

APHP180679

2018-A03239 (Other Identifier)

Details and patient eligibility

About

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)

Full description

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.

Enrollment: 45 patients

Sex: All

Ages: 7 to 18 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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45 participants in 3 patient groups

confirmed auditory processing disorders

Experimental group

Description:

functional MRI, Cortical Brainstem Auditory Evoked Potential, Genetic

Treatment:

Diagnostic Test: Automated Cortical Brainstem Auditory Evoked Potential

Diagnostic Test: functional MRI

Genetic: whole exome sequencing

suspected not confirmed auditory processing disorders

Experimental group

Description:

functional MRI, Cortical Brainstem Auditory Evoked Potential, Genetic

Treatment:

Diagnostic Test: Automated Cortical Brainstem Auditory Evoked Potential

Diagnostic Test: functional MRI

healthy volunteers

Active Comparator group

Description:

functional MRI, Cortical Brainstem Auditory Evoked Potential, Genetic, multidisciplinary consultation

Treatment:

Diagnostic Test: Automated Cortical Brainstem Auditory Evoked Potential

Diagnostic Test: functional MRI

Diagnostic Test: multidisciplinary consultation

Diagnostic Test: Standard Cortical Brainstem Auditory Evoked Potential