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ClinicalIndex Comparison Record
N/ACompleted· 45 enrolled
Drug / intervention
whole exome sequencing +4 moregenetic
Likely dose
Not stated in record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03887182
NCT03887182N/ACompleted
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Contribution of Functional MRI in Assessment of Auditory Processing Disorders

Assistance Publique - Hôpitaux de Paris·interventional·Posted Mar 22, 2019·Updated Mar 23, 2026

In Brief

A clinical study evaluating functional MRI, Automated Cortical Brainstem Auditory Evoked Potential, and 3 other interventions for Auditory Processing Disorders. Completed, enrolled 45 participants across 1 site.

Detailed 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)

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAuditory Processing Disorders
CountriesFrance
CollaboratorsURC-CIC Paris Descartes Necker Cochin

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedMar 22, 2019
Enrollment StartSep 2, 2020
Primary CompletionOct 10, 2023
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 7.3 years ago

Interventions

functional MRIother

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

Automated Cortical Brainstem Auditory Evoked Potentialother

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

whole exome sequencinggenetic

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 Potentialother

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

multidisciplinary consultationother

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