Clinical trial

Contribution of Functional MRI in Assessment of Auditory Processing Disorders

Name

APHP180679

Description

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)

Trial arms

Trial start

2020-09-01

Estimated PCD

2023-12-01

Trial end

2023-12-01

Status

Active (not recruiting)

Treatment

functional MRI

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

Arms:

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

Automated Cortical Brainstem Auditory Evoked Potential

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

Arms:

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

whole exome sequencing

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

Arms:

confirmed auditory processing disorders

Standard Cortical Brainstem Auditory Evoked Potential

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

Arms:

healthy volunteers

multidisciplinary consultation

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

Arms:

healthy volunteers

Size

Primary endpoint

BOLD effect

up to 4 weeks

Eligibility criteria

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'DIAGNOSTIC', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 45, 'type': 'ACTUAL'}}

Updated at

2023-03-16

1 organization

1 product

1 indication

Organization

Assistance Publique - Hôpitaux de Paris

Product

Whole exome sequencing

Indication

Auditory Processing Disorder