Clinical trial NCT03887182: Contribution of Functional MRI in Assessment of Auditory Processing Disorders
Official title: Contribution of Functional MRI in Assessment of Auditory Processing Disorders
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Auditory Processing Disorders
Keywords: auditory processing disorders
functional MRI
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2019-03-22
Enrollment: 45
Sex: ALL
Minimum age (years): 7
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: 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: 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.

Eligibility 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

Primary outcomes:
measure: BOLD effect
timeFrame: up to 4 weeks
Secondary outcomes:
measure: set disyllabic words (Fournier or Boorsma lists)
timeFrame: up to 4 weeks
measure: RapDys
timeFrame: up to 4 weeks
measure: Random Gap Detection Test (RGDT)
timeFrame: up to 4 weeks
measure: Dichotic listening test
timeFrame: up to 4 weeks
measure: temporal pattern recognition test
timeFrame: up to 4 weeks
measure: Test of Everyday Attention for Children (TEA-Ch test)
timeFrame: up to 4 weeks
measure: Wechsler Intelligence Scale for Children (WISC-V) test
timeFrame: up to 4 weeks
measure: Chromosomal analysis (group 1 only)
timeFrame: up to 12 months
measure: Work Environment Scale (WES) sequencing (group 1 only)
timeFrame: up to 12 months
measure: Measures of P1, N1, P2, N2 waves' Latencies
timeFrame: At inclusion day (visit 1) and at 12 months (group 1 and 2 only)
measure: Measures of P1, N1, P2, N2 waves' amplitudes
timeFrame: At inclusion day (visit 1) and at 12 months (group 1 an 2 only)
measure: Infusion Rate (MRI-ASL)
timeFrame: up to 4 weeks
measure: tractography results (DTI sequence)
timeFrame: up to 4 weeks
Other outcomes:
Locations:
city: Paris
country: France
facility: Necker Hospital
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Isabelle Rouillon, MD, PhD
role: STUDY_DIRECTOR
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