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Completed

NCT Number: NCT03887182

Contribution of Functional MRI in Assessment of Auditory Processing Disorders

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)

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Key information

Conditions

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

Age range

7 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Necker Hospital

Paris, 75015, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Functional MRI

Diagnostic Test

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

Automated Cortical Brainstem Auditory Evoked Potential

Diagnostic Test

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

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

Standard Cortical Brainstem Auditory Evoked Potential

Diagnostic Test

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

multidisciplinary consultation

Diagnostic Test

multidisciplinary consultation is composed of:

  • an ENT consultation and audiometry
  • a speech therapy assessment
  • a psychometric evaluation

Primary outcomes

  1. BOLD effect

    Time frame: up to 4 weeks

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

Secondary outcomes

  1. 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

  2. RapDys

    Time frame: up to 4 weeks

    Speech evaluation

  3. Random Gap Detection Test (RGDT)

    Time frame: up to 4 weeks

    Speech evaluation

  4. Dichotic listening test

    Time frame: up to 4 weeks

    Speech evaluation

  5. temporal pattern recognition test

    Time frame: up to 4 weeks

    Speech evaluation

  6. Test of Everyday Attention for Children (TEA-Ch test)

    Time frame: up to 4 weeks

    Psychometric evaluation for children aged 7-12 years

  7. Wechsler Intelligence Scale for Children (WISC-V) test

    Time frame: up to 4 weeks

    Psychometric evaluation for children aged 13-18 years

  8. Chromosomal analysis (group 1 only)

    Time frame: up to 12 months

    Genetic analysis

  9. Work Environment Scale (WES) sequencing (group 1 only)

    Time frame: up to 12 months

    Genetic analysis

  10. 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

  11. 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

  12. Infusion Rate (MRI-ASL)

    Time frame: up to 4 weeks

    Infusion Rate (MRI-ASL) is measured during MRI

  13. tractography results (DTI sequence)

    Time frame: up to 4 weeks

    tractography results (DTI sequence) is measured during MRI

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • URC-CIC Paris Descartes Necker Cochin

Registry information

Acronym: IRMf-TTA

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Mar 22, 2019
Registry last updated
Mar 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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