Viewing Study NCT03887182



Ignite Creation Date: 2024-05-06 @ 12:55 PM
Last Modification Date: 2024-10-26 @ 1:06 PM
Study NCT ID: NCT03887182
Status: UNKNOWN
Last Update Posted: 2023-03-16
First Post: 2019-02-12

Brief Title: Contribution of Functional MRI in Assessment of Auditory Processing Disorders
Sponsor: Assistance Publique - Hôpitaux de Paris
Organization: Assistance Publique - Hôpitaux de Paris

Study Overview

Official Title: Contribution of Functional MRI in Assessment of Auditory Processing Disorders
Status: UNKNOWN
Status Verified Date: 2022-07
Last Known Status: ACTIVE_NOT_RECRUITING
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: IRMf-TTA
Brief Summary: Auditory Processing Disorder APD affects 05-7 of the pediatric population This disorder is responsible for a childs 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 APDs will improve the care management of these children

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
2018-A03239 OTHER ID-RCB None