Auditory Processing Disorders Clinical Trial
— IRMf-TTAOfficial title:
Contribution of Functional MRI in Assessment of Auditory Processing Disorders
| Verified date | July 2022 |
| Source | Assistance Publique - Hôpitaux de Paris |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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)
| Status | Active, not recruiting |
| Enrollment | 45 |
| Est. completion date | December 2023 |
| Est. primary completion date | December 2023 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 7 Years to 18 Years |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| France | Necker Hospital | Paris |
| Lead Sponsor | Collaborator |
|---|---|
| Assistance Publique - Hôpitaux de Paris |
France,
Anderson S, Chandrasekaran B, Yi HG, Kraus N. Cortical-evoked potentials reflect speech-in-noise perception in children. Eur J Neurosci. 2010 Oct;32(8):1407-13. doi: 10.1111/j.1460-9568.2010.07409.x. — View Citation
Barker MD, Kuruvilla-Mathew A, Purdy SC. Cortical Auditory-Evoked Potential and Behavioral Evidence for Differences in Auditory Processing between Good and Poor Readers. J Am Acad Audiol. 2017 Jun;28(6):534-545. doi: 10.3766/jaaa.16054. — View Citation
Bartel-Friedrich S, Broecker Y, Knoergen M, Koesling S. Development of fMRI tests for children with central auditory processing disorders. In Vivo. 2010 Mar-Apr;24(2):201-9. — View Citation
Belin P, Zatorre RJ, Lafaille P, Ahad P, Pike B. Voice-selective areas in human auditory cortex. Nature. 2000 Jan 20;403(6767):309-12. doi: 10.1038/35002078. — View Citation
Chermak GD, Bamiou DE, Vivian Iliadou V, Musiek FE. Practical guidelines to minimise language and cognitive confounds in the diagnosis of CAPD: a brief tutorial. Int J Audiol. 2017 Jul;56(7):499-506. doi: 10.1080/14992027.2017.1284351. Epub 2017 Feb 28. — View Citation
Cunningham J, Nicol T, Zecker S, Kraus N. Speech-evoked neurophysiologic responses in children with learning problems: development and behavioral correlates of perception. Ear Hear. 2000 Dec;21(6):554-68. doi: 10.1097/00003446-200012000-00003. — View Citation
de Wit E, Visser-Bochane MI, Steenbergen B, van Dijk P, van der Schans CP, Luinge MR. Characteristics of Auditory Processing Disorders: A Systematic Review. J Speech Lang Hear Res. 2016 Apr 1;59(2):384-413. doi: 10.1044/2015_JSLHR-H-15-0118. — View Citation
Demanez L, Dony-Closon B, Lhonneux-Ledoux E, Demanez JP. Central auditory processing assessment: a French-speaking battery. Acta Otorhinolaryngol Belg. 2003;57(4):275-90. — View Citation
Kim MJ, Jeon HA, Lee KM, Son YD, Kim YB, Cho ZH. Neuroimaging features in a case of developmental central auditory processing disorder. J Neurol Sci. 2009 Feb 15;277(1-2):176-80. doi: 10.1016/j.jns.2008.10.020. Epub 2008 Dec 6. — View Citation
Martin BA, Tremblay KL, Korczak P. Speech evoked potentials: from the laboratory to the clinic. Ear Hear. 2008 Jun;29(3):285-313. doi: 10.1097/AUD.0b013e3181662c0e. Erratum In: Ear Hear. 2008 Dec;29(6):979. — View Citation
Micallef LA. Auditory Processing Disorder (APD): Progress in Diagnostics So Far. A Mini-Review on Imaging Techniques. J Int Adv Otol. 2015 Dec;11(3):257-61. doi: 10.5152/iao.2015.1009. — View Citation
Moore DR, Ferguson MA, Edmondson-Jones AM, Ratib S, Riley A. Nature of auditory processing disorder in children. Pediatrics. 2010 Aug;126(2):e382-90. doi: 10.1542/peds.2009-2826. Epub 2010 Jul 26. — View Citation
Owen JP, Marco EJ, Desai S, Fourie E, Harris J, Hill SS, Arnett AB, Mukherjee P. Abnormal white matter microstructure in children with sensory processing disorders. Neuroimage Clin. 2013 Jun 23;2:844-53. doi: 10.1016/j.nicl.2013.06.009. eCollection 2013. — View Citation
Pluta A, Wolak T, Czajka N, Lewandowska M, Ciesla K, Rusiniak M, Grudzien D, Skarzynski H. Reduced resting-state brain activity in the default mode network in children with (central) auditory processing disorders. Behav Brain Funct. 2014 Sep 26;10(1):33. doi: 10.1186/1744-9081-10-33. — View Citation
Punch S, Van Dun B, King A, Carter L, Pearce W. Clinical Experience of Using Cortical Auditory Evoked Potentials in the Treatment of Infant Hearing Loss in Australia. Semin Hear. 2016 Feb;37(1):36-52. doi: 10.1055/s-0035-1570331. — View Citation
Purdy SC, Kelly AS, Davies MG. Auditory brainstem response, middle latency response, and late cortical evoked potentials in children with learning disabilities. J Am Acad Audiol. 2002 Jul-Aug;13(7):367-82. — View Citation
Sharma A, Dorman MF, Spahr AJ. Rapid development of cortical auditory evoked potentials after early cochlear implantation. Neuroreport. 2002 Jul 19;13(10):1365-8. doi: 10.1097/00001756-200207190-00030. — View Citation
Sharma A, Glick H, Campbell J, Biever A. CENTRAL AUDTIORY DEVELOPMENT IN CHILDREN WITH HEARING LOSS: CLINICAL RELEVANCE OF THE P1 CAEP BIOMARKER IN HEARING-IMPAIRED CHILDREN WITH MULTIPLE DISABILITIES. Hearing Balance Commun. 2013 Sep;11(3):10.3109/21695717.2013.812378. doi: 10.3109/21695717.2013.812378. — View Citation
Sharma A, Kraus N, McGee TJ, Nicol TG. Developmental changes in P1 and N1 central auditory responses elicited by consonant-vowel syllables. Electroencephalogr Clin Neurophysiol. 1997 Nov;104(6):540-5. doi: 10.1016/s0168-5597(97)00050-6. — View Citation
Sharma A, Martin K, Roland P, Bauer P, Sweeney MH, Gilley P, Dorman M. P1 latency as a biomarker for central auditory development in children with hearing impairment. J Am Acad Audiol. 2005 Sep;16(8):564-73. doi: 10.3766/jaaa.16.8.5. — View Citation
Sharma M, Purdy S C, Kelly A S. The contribution of speech-evoked cortical auditory evoked potentials to the diagnosis and measurement of intervention outcomes in children with auditory processing disorder. Semin Hear. 2014;35(1):51-64
Sharma M, Purdy SC, Kelly AS. Comorbidity of auditory processing, language, and reading disorders. J Speech Lang Hear Res. 2009 Jun;52(3):706-22. doi: 10.1044/1092-4388(2008/07-0226). Epub 2008 Dec 8. — View Citation
Thomsen T, Rimol LM, Ersland L, Hugdahl K. Dichotic listening reveals functional specificity in prefrontal cortex: an fMRI study. Neuroimage. 2004 Jan;21(1):211-8. doi: 10.1016/j.neuroimage.2003.08.039. — View Citation
Tomlin D, Rance G. Maturation of the Central Auditory Nervous System in Children with Auditory Processing Disorder. Semin Hear. 2016 Feb;37(1):74-83. doi: 10.1055/s-0035-1570328. — View Citation
* Note: There are 24 references in all — Click here to view all references
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | BOLD effect | BOLD effect is measured during fMRI and compared between the 3 groups of patients | up to 4 weeks | |
| Secondary | 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 | up to 4 weeks | |
| Secondary | RapDys | Speech evaluation | up to 4 weeks | |
| Secondary | Random Gap Detection Test (RGDT) | Speech evaluation | up to 4 weeks | |
| Secondary | Dichotic listening test | Speech evaluation | up to 4 weeks | |
| Secondary | temporal pattern recognition test | Speech evaluation | up to 4 weeks | |
| Secondary | Test of Everyday Attention for Children (TEA-Ch test) | Psychometric evaluation for children aged 7-12 years | up to 4 weeks | |
| Secondary | Wechsler Intelligence Scale for Children (WISC-V) test | Psychometric evaluation for children aged 13-18 years | up to 4 weeks | |
| Secondary | Chromosomal analysis (group 1 only) | Genetic analysis | up to 12 months | |
| Secondary | Work Environment Scale (WES) sequencing (group 1 only) | Genetic analysis | up to 12 months | |
| Secondary | Measures of P1, N1, P2, N2 waves' Latencies | Cortical Brainstem Auditory Evoked | At inclusion day (visit 1) and at 12 months (group 1 and 2 only) | |
| Secondary | Measures of P1, N1, P2, N2 waves' amplitudes | Cortical Brainstem Auditory Evoked | At inclusion day (visit 1) and at 12 months (group 1 an 2 only) | |
| Secondary | Infusion Rate (MRI-ASL) | Infusion Rate (MRI-ASL) is measured during MRI | up to 4 weeks | |
| Secondary | tractography results (DTI sequence) | tractography results (DTI sequence) is measured during MRI | up to 4 weeks |