Contribution of Functional MRI in Assessment of Auditory Processing Disorders (IRMf-TTA)

March 15, 2023 updated by: Assistance Publique - Hôpitaux de Paris

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 Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Paris, France, 75015
        • Necker Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: confirmed auditory processing disorders
functional MRI, Cortical Brainstem Auditory Evoked Potential, Genetic
Diagnostic test: functional MRI
Additional sequence (DTI) and functional MRI (fMRI) during the MRI which is done as part of the usual care
Diagnostic test: Automated Cortical Brainstem Auditory Evoked Potential
Automated Cortical Brainstem Auditory Evoked Potential correspond to a non-invasive EEG
Genetic: 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
Experimental: suspected not confirmed auditory processing disorders
functional MRI, Cortical Brainstem Auditory Evoked Potential, Genetic
Diagnostic test: functional MRI
Additional sequence (DTI) and functional MRI (fMRI) during the MRI which is done as part of the usual care
Diagnostic test: Automated Cortical Brainstem Auditory Evoked Potential
Automated Cortical Brainstem Auditory Evoked Potential correspond to a non-invasive EEG
Active Comparator: healthy volunteers
functional MRI, Cortical Brainstem Auditory Evoked Potential, Genetic, multidisciplinary consultation
Diagnostic test: functional MRI
Additional sequence (DTI) and functional MRI (fMRI) during the MRI which is done as part of the usual care
Diagnostic test: Automated Cortical Brainstem Auditory Evoked Potential
Automated Cortical Brainstem Auditory Evoked Potential correspond to a non-invasive EEG
Diagnostic test: Standard Cortical Brainstem Auditory Evoked Potential
Standard Cortical Brainstem Auditory Evoked Potential correspond to a non-invasive EEG
Diagnostic test: multidisciplinary consultation

multidisciplinary consultation is composed of:

  • an ENT consultation and audiometry
  • a speech therapy assessment
  • a psychometric evaluation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
BOLD effect
Time Frame: up to 4 weeks
BOLD effect is measured during fMRI and compared between the 3 groups of patients
up to 4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
set disyllabic words (Fournier or Boorsma lists)
Time Frame: up to 4 weeks
Speech evaluation : set disyllabic words using the Fournier or Boorsma lists (the French equivalent of the. Peabody PBK test), depending on age
up to 4 weeks
RapDys
Time Frame: up to 4 weeks
Speech evaluation
up to 4 weeks
Random Gap Detection Test (RGDT)
Time Frame: up to 4 weeks
Speech evaluation
up to 4 weeks
Dichotic listening test
Time Frame: up to 4 weeks
Speech evaluation
up to 4 weeks
temporal pattern recognition test
Time Frame: up to 4 weeks
Speech evaluation
up to 4 weeks
Test of Everyday Attention for Children (TEA-Ch test)
Time Frame: up to 4 weeks
Psychometric evaluation for children aged 7-12 years
up to 4 weeks
Wechsler Intelligence Scale for Children (WISC-V) test
Time Frame: up to 4 weeks
Psychometric evaluation for children aged 13-18 years
up to 4 weeks
Chromosomal analysis (group 1 only)
Time Frame: up to 12 months
Genetic analysis
up to 12 months
Work Environment Scale (WES) sequencing (group 1 only)
Time Frame: up to 12 months
Genetic analysis
up to 12 months
Measures of P1, N1, P2, N2 waves' Latencies
Time Frame: At inclusion day (visit 1) and at 12 months (group 1 and 2 only)
Cortical Brainstem Auditory Evoked
At inclusion day (visit 1) and at 12 months (group 1 and 2 only)
Measures of P1, N1, P2, N2 waves' amplitudes
Time Frame: At inclusion day (visit 1) and at 12 months (group 1 an 2 only)
Cortical Brainstem Auditory Evoked
At inclusion day (visit 1) and at 12 months (group 1 an 2 only)
Infusion Rate (MRI-ASL)
Time Frame: up to 4 weeks
Infusion Rate (MRI-ASL) is measured during MRI
up to 4 weeks
tractography results (DTI sequence)
Time Frame: up to 4 weeks
tractography results (DTI sequence) is measured during MRI
up to 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigators

  • Study Director: Isabelle Rouillon, MD, PhD, Assistance Publique - Hôpitaux de Paris

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2020

Primary Completion (Anticipated)

December 1, 2023

Study Completion (Anticipated)

December 1, 2023

Study Registration Dates

First Submitted

February 12, 2019

First Submitted That Met QC Criteria

March 21, 2019

First Posted (Actual)

March 22, 2019

Study Record Updates

Last Update Posted (Actual)

March 16, 2023

Last Update Submitted That Met QC Criteria

March 15, 2023

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APHP180679
  • 2018-A03239 (Other Identifier: ID-RCB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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