Contribution of Functional MRI in Assessment of Auditory Processing Disorders

Overview

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)

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Diagnostic
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2023

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.

Interventions

  • Diagnostic Test: functional MRI
    • Additional sequence (DTI) and functional MRI (fMRI) during the MRI which is done as part of the usual care
  • Diagnostic Test: Automated Cortical Brainstem Auditory Evoked Potential
    • Automated Cortical Brainstem Auditory Evoked Potential correspond to a non-invasive EEG
  • Genetic: whole exome sequencing
    • A study of all the DNA-encoding exons of the child/parent from a sample taken as part of the usual care
  • Diagnostic Test: Standard Cortical Brainstem Auditory Evoked Potential
    • Standard Cortical Brainstem Auditory Evoked Potential correspond to a non-invasive EEG
  • Diagnostic Test: multidisciplinary consultation
    • multidisciplinary consultation is composed of: an ENT consultation and audiometry a speech therapy assessment a psychometric evaluation

Arms, Groups and Cohorts

  • Experimental: confirmed auditory processing disorders
    • functional MRI, Cortical Brainstem Auditory Evoked Potential, Genetic
  • Experimental: suspected not confirmed auditory processing disorders
    • functional MRI, Cortical Brainstem Auditory Evoked Potential, Genetic
  • Active Comparator: healthy volunteers
    • functional MRI, Cortical Brainstem Auditory Evoked Potential, Genetic, multidisciplinary consultation

Clinical Trial Outcome Measures

Primary Measures

  • BOLD effect
    • Time Frame: up to 4 weeks
    • BOLD effect is measured during fMRI and compared between the 3 groups of patients

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 7 Years

Maximum Age: 18 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Assistance Publique – Hôpitaux de Paris
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Isabelle Rouillon, MD, PhD, Study Director, Assistance Publique – Hôpitaux de Paris

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