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Contribution of Functional MRI in Assessment of Auditory Processing Disorders

Contribution of Functional MRI in Assessment of Auditory Processing Disorders

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03887182
Acronym
IRMf-TTA
Enrollment
45
Registered
2019-03-22
Start date
2020-09-02
Completion date
2023-10-10
Last updated
2026-03-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Auditory Processing Disorders

Keywords

auditory processing disorders, functional MRI

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.

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

Sponsors

Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER
URC-CIC Paris Descartes Necker Cochin
CollaboratorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
7 Years to 18 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
BOLD effectup to 4 weeksBOLD effect is measured during fMRI and compared between the 3 groups of patients

Secondary

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

Countries

France

Contacts

STUDY_DIRECTORIsabelle Rouillon, MD, PhD

Assistance Publique - Hôpitaux de Paris

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 24, 2026