ClinicalTrials.gg
CompletedNCT03887182IRMf-TTAUpdated Mar 23, 2026

Contribution of Functional MRI in Assessment of Auditory Processing Disorders

An interventional study of functional MRI and Automated Cortical Brainstem Auditory Evoked Potential in Auditory Processing Disorders, sponsored by Assistance Publique - Hôpitaux de Paris. Completed at 1 site in France. Open to participants aged 7 Years to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-23.

Sponsored by Assistance Publique - Hôpitaux de Paris · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
45
Allocation
Non-randomized
Ages
7 Years to 18 Years
Sex
All
01

Study 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)
Read the 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.

02

Conditions studied

  • Auditory Processing Disorders

Keywords

  • auditory processing disorders
  • functional MRI
03

In context

Auditory Perceptual Disorders

24 studies on the registry are indexed under Auditory Perceptual Disorders; 3 are open to participants now.

This study's enrollment of 45 is below the median of 52 across 18 interventional studies indexed under Auditory Perceptual Disorders.

Browse Auditory Perceptual Disorders studies →

Lead sponsor

Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,592 studies on the registry; 1,033 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
7 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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

Exclusion Criteria:

  • Require general anesthesia for MRI
  • to MRI
  • Hearing aids for more than three months prior to inclusion in the study
  • Require sedation specifically for research
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
45 participants (actual)

Study arms

  • Experimental
    confirmed auditory processing disorders

    functional MRI, Cortical Brainstem Auditory Evoked Potential, Genetic

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

  • Experimental
    suspected not confirmed auditory processing disorders

    functional MRI, Cortical Brainstem Auditory Evoked Potential, Genetic

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

  • Active comparator
    healthy volunteers

    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

  • Diagnostic testfunctional MRI

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

  • Diagnostic testAutomated Cortical Brainstem Auditory Evoked Potential

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

  • Geneticwhole 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 testStandard Cortical Brainstem Auditory Evoked Potential

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

  • Diagnostic testmultidisciplinary consultation

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

06

What researchers measure

Primary outcomes

  1. BOLD effect

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

    Time frame: up to 4 weeks

Secondary outcomes

  1. set disyllabic words (Fournier or Boorsma lists)

    Speech evaluation : set disyllabic words using the Fournier or Boorsma lists (the French equivalent of the. Peabody PBK test), depending on age

    Time frame: up to 4 weeks

  2. RapDys

    Speech evaluation

    Time frame: up to 4 weeks

  3. Random Gap Detection Test (RGDT)

    Speech evaluation

    Time frame: up to 4 weeks

  4. Dichotic listening test

    Speech evaluation

    Time frame: up to 4 weeks

  5. temporal pattern recognition test

    Speech evaluation

    Time frame: up to 4 weeks

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

    Psychometric evaluation for children aged 7-12 years

    Time frame: up to 4 weeks

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

    Psychometric evaluation for children aged 13-18 years

    Time frame: up to 4 weeks

  8. Chromosomal analysis (group 1 only)

    Genetic analysis

    Time frame: up to 12 months

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

    Genetic analysis

    Time frame: up to 12 months

  10. Measures of P1, N1, P2, N2 waves' Latencies

    Cortical Brainstem Auditory Evoked

    Time frame: At inclusion day (visit 1) and at 12 months (group 1 and 2 only)

  11. Measures of P1, N1, P2, N2 waves' amplitudes

    Cortical Brainstem Auditory Evoked

    Time frame: At inclusion day (visit 1) and at 12 months (group 1 an 2 only)

  12. Infusion Rate (MRI-ASL)

    Infusion Rate (MRI-ASL) is measured during MRI

    Time frame: up to 4 weeks

  13. tractography results (DTI sequence)

    tractography results (DTI sequence) is measured during MRI

    Time frame: up to 4 weeks

07

Study locations

1 site
  • Necker Hospital
    Paris, 75015, France
08

References and documents

Publications

  • Chermak GD, Bamiou DE, Vivian Iliadou V, Musiek FE. Practical guidelines to minimise language and cognitive confounds in the diagnosis of CAPD: a brief tutorial. Int J Audiol. 2017 Jul;56(7):499-506. doi: 10.1080/14992027.2017.1284351. Epub 2017 Feb 28. PubMed 28635503 ↗
  • Moore DR, Ferguson MA, Edmondson-Jones AM, Ratib S, Riley A. Nature of auditory processing disorder in children. Pediatrics. 2010 Aug;126(2):e382-90. doi: 10.1542/peds.2009-2826. Epub 2010 Jul 26. PubMed 20660546 ↗
  • Barker MD, Kuruvilla-Mathew A, Purdy SC. Cortical Auditory-Evoked Potential and Behavioral Evidence for Differences in Auditory Processing between Good and Poor Readers. J Am Acad Audiol. 2017 Jun;28(6):534-545. doi: 10.3766/jaaa.16054. PubMed 28590897 ↗
  • Tomlin D, Rance G. Maturation of the Central Auditory Nervous System in Children with Auditory Processing Disorder. Semin Hear. 2016 Feb;37(1):74-83. doi: 10.1055/s-0035-1570328. PubMed 27587924 ↗
  • Sharma M, Purdy SC, Kelly AS. Comorbidity of auditory processing, language, and reading disorders. J Speech Lang Hear Res. 2009 Jun;52(3):706-22. doi: 10.1044/1092-4388(2008/07-0226). Epub 2008 Dec 8. PubMed 19064904 ↗
  • de Wit E, Visser-Bochane MI, Steenbergen B, van Dijk P, van der Schans CP, Luinge MR. Characteristics of Auditory Processing Disorders: A Systematic Review. J Speech Lang Hear Res. 2016 Apr 1;59(2):384-413. doi: 10.1044/2015_JSLHR-H-15-0118. PubMed 27082630 ↗
  • Demanez L, Dony-Closon B, Lhonneux-Ledoux E, Demanez JP. Central auditory processing assessment: a French-speaking battery. Acta Otorhinolaryngol Belg. 2003;57(4):275-90. PubMed 14714945 ↗
  • Sharma A, Kraus N, McGee TJ, Nicol TG. Developmental changes in P1 and N1 central auditory responses elicited by consonant-vowel syllables. Electroencephalogr Clin Neurophysiol. 1997 Nov;104(6):540-5. doi: 10.1016/s0168-5597(97)00050-6. PubMed 9402896 ↗
  • Sharma A, Dorman MF, Spahr AJ. Rapid development of cortical auditory evoked potentials after early cochlear implantation. Neuroreport. 2002 Jul 19;13(10):1365-8. doi: 10.1097/00001756-200207190-00030. PubMed 12151804 ↗
  • Sharma A, Martin K, Roland P, Bauer P, Sweeney MH, Gilley P, Dorman M. P1 latency as a biomarker for central auditory development in children with hearing impairment. J Am Acad Audiol. 2005 Sep;16(8):564-73. doi: 10.3766/jaaa.16.8.5. PubMed 16295243 ↗
  • Sharma A, Glick H, Campbell J, Biever A. CENTRAL AUDTIORY DEVELOPMENT IN CHILDREN WITH HEARING LOSS: CLINICAL RELEVANCE OF THE P1 CAEP BIOMARKER IN HEARING-IMPAIRED CHILDREN WITH MULTIPLE DISABILITIES. Hearing Balance Commun. 2013 Sep;11(3):10.3109/21695717.2013.812378. doi: 10.3109/21695717.2013.812378. PubMed 24273704 ↗
  • Sharma M, Purdy S C, Kelly A S. The contribution of speech-evoked cortical auditory evoked potentials to the diagnosis and measurement of intervention outcomes in children with auditory processing disorder. Semin Hear. 2014;35(1):51-64
  • Purdy SC, Kelly AS, Davies MG. Auditory brainstem response, middle latency response, and late cortical evoked potentials in children with learning disabilities. J Am Acad Audiol. 2002 Jul-Aug;13(7):367-82. PubMed 12199513 ↗
  • Anderson S, Chandrasekaran B, Yi HG, Kraus N. Cortical-evoked potentials reflect speech-in-noise perception in children. Eur J Neurosci. 2010 Oct;32(8):1407-13. doi: 10.1111/j.1460-9568.2010.07409.x. PubMed 20950282 ↗
  • Cunningham J, Nicol T, Zecker S, Kraus N. Speech-evoked neurophysiologic responses in children with learning problems: development and behavioral correlates of perception. Ear Hear. 2000 Dec;21(6):554-68. doi: 10.1097/00003446-200012000-00003. PubMed 11132782 ↗
  • Punch S, Van Dun B, King A, Carter L, Pearce W. Clinical Experience of Using Cortical Auditory Evoked Potentials in the Treatment of Infant Hearing Loss in Australia. Semin Hear. 2016 Feb;37(1):36-52. doi: 10.1055/s-0035-1570331. PubMed 27587921 ↗
  • Martin BA, Tremblay KL, Korczak P. Speech evoked potentials: from the laboratory to the clinic. Ear Hear. 2008 Jun;29(3):285-313. doi: 10.1097/AUD.0b013e3181662c0e. PubMed 18453883 ↗
  • Micallef LA. Auditory Processing Disorder (APD): Progress in Diagnostics So Far. A Mini-Review on Imaging Techniques. J Int Adv Otol. 2015 Dec;11(3):257-61. doi: 10.5152/iao.2015.1009. PubMed 26915160 ↗
  • Owen JP, Marco EJ, Desai S, Fourie E, Harris J, Hill SS, Arnett AB, Mukherjee P. Abnormal white matter microstructure in children with sensory processing disorders. Neuroimage Clin. 2013 Jun 23;2:844-53. doi: 10.1016/j.nicl.2013.06.009. eCollection 2013. PubMed 24179836 ↗
  • Kim MJ, Jeon HA, Lee KM, Son YD, Kim YB, Cho ZH. Neuroimaging features in a case of developmental central auditory processing disorder. J Neurol Sci. 2009 Feb 15;277(1-2):176-80. doi: 10.1016/j.jns.2008.10.020. Epub 2008 Dec 6. PubMed 19058816 ↗
  • Belin P, Zatorre RJ, Lafaille P, Ahad P, Pike B. Voice-selective areas in human auditory cortex. Nature. 2000 Jan 20;403(6767):309-12. doi: 10.1038/35002078. PubMed 10659849 ↗
  • Thomsen T, Rimol LM, Ersland L, Hugdahl K. Dichotic listening reveals functional specificity in prefrontal cortex: an fMRI study. Neuroimage. 2004 Jan;21(1):211-8. doi: 10.1016/j.neuroimage.2003.08.039. PubMed 14741658 ↗
  • Pluta A, Wolak T, Czajka N, Lewandowska M, Ciesla K, Rusiniak M, Grudzien D, Skarzynski H. Reduced resting-state brain activity in the default mode network in children with (central) auditory processing disorders. Behav Brain Funct. 2014 Sep 26;10(1):33. doi: 10.1186/1744-9081-10-33. PubMed 25261349 ↗
  • Bartel-Friedrich S, Broecker Y, Knoergen M, Koesling S. Development of fMRI tests for children with central auditory processing disorders. In Vivo. 2010 Mar-Apr;24(2):201-9. PubMed 20363995 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 23, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03887182
Collaborators
URC-CIC Paris Descartes Necker Cochin
Responsible party
Sponsor
First posted
Mar 22, 2019
Start date
Sep 2, 2020
Primary completion
Oct 10, 2023
Completion
Oct 10, 2023
Last update
Mar 23, 2026

Study contacts

Isabelle Rouillon, MD, PhD
study director · Assistance Publique - Hôpitaux de Paris

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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