Contribution of Functional MRI in Assessment of Auditory Processing Disorders (IRMf-TTA)
Primary Purpose
Auditory Processing Disorders
Status
Active
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
functional MRI
Automated Cortical Brainstem Auditory Evoked Potential
whole exome sequencing
Standard Cortical Brainstem Auditory Evoked Potential
multidisciplinary consultation
Sponsored by
About this trial
This is an interventional diagnostic trial for Auditory Processing Disorders focused on measuring auditory processing disorders, functional MRI
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
Sites / Locations
- Necker Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
confirmed auditory processing disorders
suspected not confirmed auditory processing disorders
healthy volunteers
Arm Description
functional MRI, Cortical Brainstem Auditory Evoked Potential, Genetic
functional MRI, Cortical Brainstem Auditory Evoked Potential, Genetic
functional MRI, Cortical Brainstem Auditory Evoked Potential, Genetic, multidisciplinary consultation
Outcomes
Primary Outcome Measures
BOLD effect
BOLD effect is measured during fMRI and compared between the 3 groups of patients
Secondary Outcome Measures
set disyllabic words (Fournier or Boorsma lists)
Speech evaluation : set disyllabic words using the Fournier or Boorsma lists (the French equivalent of the. Peabody PBK test), depending on age
RapDys
Speech evaluation
Random Gap Detection Test (RGDT)
Speech evaluation
Dichotic listening test
Speech evaluation
temporal pattern recognition test
Speech evaluation
Test of Everyday Attention for Children (TEA-Ch test)
Psychometric evaluation for children aged 7-12 years
Wechsler Intelligence Scale for Children (WISC-V) test
Psychometric evaluation for children aged 13-18 years
Chromosomal analysis (group 1 only)
Genetic analysis
Work Environment Scale (WES) sequencing (group 1 only)
Genetic analysis
Measures of P1, N1, P2, N2 waves' Latencies
Cortical Brainstem Auditory Evoked
Measures of P1, N1, P2, N2 waves' amplitudes
Cortical Brainstem Auditory Evoked
Infusion Rate (MRI-ASL)
Infusion Rate (MRI-ASL) is measured during MRI
tractography results (DTI sequence)
tractography results (DTI sequence) is measured during MRI
Full Information
NCT ID
NCT03887182
First Posted
February 12, 2019
Last Updated
March 15, 2023
Sponsor
Assistance Publique - Hôpitaux de Paris
1. Study Identification
Unique Protocol Identification Number
NCT03887182
Brief Title
Contribution of Functional MRI in Assessment of Auditory Processing Disorders
Acronym
IRMf-TTA
Official Title
Contribution of Functional MRI in Assessment of Auditory Processing Disorders
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 1, 2020 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Auditory Processing Disorders
Keywords
auditory processing disorders, functional MRI
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
confirmed auditory processing disorders
Arm Type
Experimental
Arm Description
functional MRI, Cortical Brainstem Auditory Evoked Potential, Genetic
Arm Title
suspected not confirmed auditory processing disorders
Arm Type
Experimental
Arm Description
functional MRI, Cortical Brainstem Auditory Evoked Potential, Genetic
Arm Title
healthy volunteers
Arm Type
Active Comparator
Arm Description
functional MRI, Cortical Brainstem Auditory Evoked Potential, Genetic, multidisciplinary consultation
Intervention Type
Diagnostic Test
Intervention Name(s)
functional MRI
Intervention Description
Additional sequence (DTI) and functional MRI (fMRI) during the MRI which is done as part of the usual care
Intervention Type
Diagnostic Test
Intervention Name(s)
Automated Cortical Brainstem Auditory Evoked Potential
Intervention Description
Automated Cortical Brainstem Auditory Evoked Potential correspond to a non-invasive EEG
Intervention Type
Genetic
Intervention Name(s)
whole exome sequencing
Intervention Description
A study of all the DNA-encoding exons of the child/parent from a sample taken as part of the usual care
Intervention Type
Diagnostic Test
Intervention Name(s)
Standard Cortical Brainstem Auditory Evoked Potential
Intervention Description
Standard Cortical Brainstem Auditory Evoked Potential correspond to a non-invasive EEG
Intervention Type
Diagnostic Test
Intervention Name(s)
multidisciplinary consultation
Intervention Description
multidisciplinary consultation is composed of:
an ENT consultation and audiometry
a speech therapy assessment
a psychometric evaluation
Primary Outcome Measure Information:
Title
BOLD effect
Description
BOLD effect is measured during fMRI and compared between the 3 groups of patients
Time Frame
up to 4 weeks
Secondary Outcome Measure Information:
Title
set disyllabic words (Fournier or Boorsma lists)
Description
Speech evaluation : set disyllabic words using the Fournier or Boorsma lists (the French equivalent of the. Peabody PBK test), depending on age
Time Frame
up to 4 weeks
Title
RapDys
Description
Speech evaluation
Time Frame
up to 4 weeks
Title
Random Gap Detection Test (RGDT)
Description
Speech evaluation
Time Frame
up to 4 weeks
Title
Dichotic listening test
Description
Speech evaluation
Time Frame
up to 4 weeks
Title
temporal pattern recognition test
Description
Speech evaluation
Time Frame
up to 4 weeks
Title
Test of Everyday Attention for Children (TEA-Ch test)
Description
Psychometric evaluation for children aged 7-12 years
Time Frame
up to 4 weeks
Title
Wechsler Intelligence Scale for Children (WISC-V) test
Description
Psychometric evaluation for children aged 13-18 years
Time Frame
up to 4 weeks
Title
Chromosomal analysis (group 1 only)
Description
Genetic analysis
Time Frame
up to 12 months
Title
Work Environment Scale (WES) sequencing (group 1 only)
Description
Genetic analysis
Time Frame
up to 12 months
Title
Measures of P1, N1, P2, N2 waves' Latencies
Description
Cortical Brainstem Auditory Evoked
Time Frame
At inclusion day (visit 1) and at 12 months (group 1 and 2 only)
Title
Measures of P1, N1, P2, N2 waves' amplitudes
Description
Cortical Brainstem Auditory Evoked
Time Frame
At inclusion day (visit 1) and at 12 months (group 1 an 2 only)
Title
Infusion Rate (MRI-ASL)
Description
Infusion Rate (MRI-ASL) is measured during MRI
Time Frame
up to 4 weeks
Title
tractography results (DTI sequence)
Description
tractography results (DTI sequence) is measured during MRI
Time Frame
up to 4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Isabelle Rouillon, MD, PhD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Study Director
Facility Information:
Facility Name
Necker Hospital
City
Paris
ZIP/Postal Code
75015
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
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Contribution of Functional MRI in Assessment of Auditory Processing Disorders
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