Contribution of Functional MRI in Assessment of Auditory Processing Disorders

NCT03887182 | Completed

• 2 other identifiers: APHP1806792018-A03239
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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)

Conditions

Auditory Processing Disorders

Keywords

auditory processing disorders; functional MRI

Outcome Measures

Primary Outcomes (1)

• BOLD effect

  BOLD effect is measured during fMRI and compared between the 3 groups of patients

  up to 4 weeks

Secondary Outcomes (13)

• set disyllabic words (Fournier or Boorsma lists)

  up to 4 weeks

• RapDys

  up to 4 weeks

• Random Gap Detection Test (RGDT)

  up to 4 weeks

• Dichotic listening test

  up to 4 weeks

• temporal pattern recognition test

  up to 4 weeks

Study Arms (3)

confirmed auditory processing disorders

EXPERIMENTAL

functional MRI, Cortical Brainstem Auditory Evoked Potential, Genetic

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

suspected not confirmed auditory processing disorders

EXPERIMENTAL

functional MRI, Cortical Brainstem Auditory Evoked Potential, Genetic

Diagnostic Test: functional MRI; Diagnostic Test: Automated Cortical Brainstem Auditory Evoked Potential

healthy volunteers

ACTIVE COMPARATOR

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

Diagnostic Test: functional MRI; Diagnostic Test: Automated Cortical Brainstem Auditory Evoked Potential; Diagnostic Test: Standard Cortical Brainstem Auditory Evoked Potential; Diagnostic Test: multidisciplinary consultation

Interventions

functional MRI DIAGNOSTIC_TEST

Additional sequence (DTI) and functional MRI (fMRI) during the MRI which is done as part of the usual care

confirmed auditory processing disorders; healthy volunteers; suspected not confirmed auditory processing disorders

Automated Cortical Brainstem Auditory Evoked Potential DIAGNOSTIC_TEST

Automated Cortical Brainstem Auditory Evoked Potential correspond to a non-invasive EEG

confirmed auditory processing disorders; healthy volunteers; suspected not confirmed auditory processing disorders

whole exome sequencing GENETIC

A study of all the DNA-encoding exons of the child/parent from a sample taken as part of the usual care

confirmed auditory processing disorders

Standard Cortical Brainstem Auditory Evoked Potential DIAGNOSTIC_TEST

Standard Cortical Brainstem Auditory Evoked Potential correspond to a non-invasive EEG

healthy volunteers

multidisciplinary consultation DIAGNOSTIC_TEST

multidisciplinary consultation is composed of: * an ENT consultation and audiometry * a speech therapy assessment * a psychometric evaluation

healthy volunteers

Eligibility Criteria

• Age: 7 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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
• to 18 years old
• do not present any known hearing pathology
• Signed consent of both parents
• Affiliated with a health insurance plan

You may not qualify if:

• Require general anesthesia for MRI
• Contraindication to MRI
• Require sedation specifically for research

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• URC-CIC Paris Descartes Necker Cochin: collaborator

Study Sites (1)

Necker Hospital

Paris, 75015, France

Location

Related Publications (24)

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  PMID: 14714945 BACKGROUND

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  PMID: 12151804 BACKGROUND

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  BACKGROUND

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  PMID: 12199513 BACKGROUND

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MeSH Terms

Conditions

Auditory Perceptual Disorders

Interventions

Magnetic Resonance Imaging; Exome Sequencing

Condition Hierarchy (Ancestors)

Auditory Diseases, Central; Retrocochlear Diseases; Ear Diseases; Otorhinolaryngologic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Whole Genome Sequencing; Sequence Analysis, DNA; Sequence Analysis; Genetic Techniques; Investigative Techniques

Study Officials

• Isabelle Rouillon, MD, PhD

  Assistance Publique - Hôpitaux de Paris

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2019
• First Posted: March 22, 2019
• Study Start: September 2, 2020
• Primary Completion: October 10, 2023
• Study Completion: October 10, 2023
• Last Updated: March 23, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)