Contribution of Functional MRI in Assessment of Auditory Processing Disorders

Not Applicable

• Conditions: Auditory Processing Disorders
• Interventions: 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

• Registration Number: NCT03887182
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Study Timeline

• Study First Submitted: 2019-02-12
• Study First Submitted QC: 2019-03-21
• Study First Posted: 2019-03-22
• Study Start: 2020-09-01
• Status Verified: 2022-07
• Last Update Submitted: 2023-03-15
• Last Update Posted: 2023-03-16
• Primary Completion: 2023-12
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
confirmed auditory processing disorders	functional MRI	functional MRI, Cortical Brainstem Auditory Evoked Potential, Genetic
confirmed auditory processing disorders	Automated Cortical Brainstem Auditory Evoked Potential	functional MRI, Cortical Brainstem Auditory Evoked Potential, Genetic
confirmed auditory processing disorders	whole exome sequencing	functional MRI, Cortical Brainstem Auditory Evoked Potential, Genetic
suspected not confirmed auditory processing disorders	Automated Cortical Brainstem Auditory Evoked Potential	functional MRI, Cortical Brainstem Auditory Evoked Potential, Genetic
healthy volunteers	Standard Cortical Brainstem Auditory Evoked Potential	functional MRI, Cortical Brainstem Auditory Evoked Potential, Genetic, multidisciplinary consultation
suspected not confirmed auditory processing disorders	functional MRI	functional MRI, Cortical Brainstem Auditory Evoked Potential, Genetic
healthy volunteers	multidisciplinary consultation	functional MRI, Cortical Brainstem Auditory Evoked Potential, Genetic, multidisciplinary consultation
healthy volunteers	functional MRI	functional MRI, Cortical Brainstem Auditory Evoked Potential, Genetic, multidisciplinary consultation
healthy volunteers	Automated Cortical Brainstem Auditory Evoked Potential	functional MRI, Cortical Brainstem Auditory Evoked Potential, Genetic, multidisciplinary consultation

Primary Outcome Measures

Name	Time	Method
BOLD effect	up to 4 weeks	BOLD effect is measured during fMRI and compared between the 3 groups of patients

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Necker Hospital; 🇫🇷 Paris, France