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- Essai clinique NCT03117413
Positron Emission Tomography Imaging of Brain Reorganisation of the Central Auditory Cortex in Asymetrical Profound Deaf Patient With a Cochlear Implantation. (UniTEP)
Positron Emission Tomography Imaging of Brain Reorganisation of the Central Auditory Cortex in Asymetrical Profound Deaf Patient With a Cochlear Implantation
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Cochlear implantation is the most efficient method to restore hearing in deaf patients. However, about 2/3 of patients have some residual hearing and these patients usually combine two types of auditory information (electrical and acoustical). It is important to know how the brain is processing during two distinct stimulations and how it is related to the auditory level of performance.
Patients and controls will undergo a positron emission tomography scan brain imaging session during a simplified voice/non-voice discrimination task. For each tasks and brain imaging sessions, patients will be stimulated either with the non-implanted ear (acoustical stimulation), the cochlear implant (electrical stimulation) and using both modalities in a binaural condition.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Toulouse, France, 31059
- CHU de Toulouse - Hôpital Purpan
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Midi-Pyrénées
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Toulouse, Midi-Pyrénées, France, 31052
- CERCO
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- cochlear implantation>3 months
- signature of informed consent
- affiliation to social service.
Exclusion Criteria:
- associated neurological disorder
- protected subjects
- epilepsy episodes
- psychotropic medication
- pregnancy
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Science basique
- Répartition: Non randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Autre: Asymmetric hearing loss
Asymmetric hearing loss treated with a cochlear implant will undergo positron emission tomography scan.
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Autre: Normal hearing subjects
Normal hearing subjects will undergo positron emission tomography scan.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Differences in auditory brain activation between cochlear implanted asymmetric hearing loss subjects and normal hearing subjects in the binaural condition.
Délai: Day 1
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Prior to the imaging session, patients performed two human voice interpretation tests.
link between temporal activations and performances obtained in binaural integration tasks in the patient group.
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Day 1
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
differences in auditory brain activation.
Délai: Week 3 - Week 5
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Auditory brain activation when the better ear is acoustically stimulated in asymmetric hearing loss subjects and when one ear is stimulated in normal hearing subjects.
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Week 3 - Week 5
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Performance level and the pattern of brain activation.
Délai: Week 3 - Week 5
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Acoustical or electrical stimulation in asymmetric hearing loss cochlear implanted subjects.
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Week 3 - Week 5
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the asymmetry in auditory brain activation for asymmetric hearing loss cochlear implanted subjects.
Délai: Week 3 - Week 5
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Electrical and acoustical stimulation will be used.
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Week 3 - Week 5
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link between binaural hearing performances and auditory brain activation in the binaural condition.
Délai: Week 3 - Week 5
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For the group of cochlear implanted subjects with asymmetric hearing loss.
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Week 3 - Week 5
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Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Mathieu Marx, Pr, CHU Toulouse
Publications et liens utiles
Publications générales
- Strelnikov K, Rouger J, Demonet JF, Lagleyre S, Fraysse B, Deguine O, Barone P. Visual activity predicts auditory recovery from deafness after adult cochlear implantation. Brain. 2013 Dec;136(Pt 12):3682-95. doi: 10.1093/brain/awt274. Epub 2013 Oct 17.
- Vannson N, James C, Fraysse B, Strelnikov K, Barone P, Deguine O, Marx M. Quality of life and auditory performance in adults with asymmetric hearing loss. Audiol Neurootol. 2015;20 Suppl 1:38-43. doi: 10.1159/000380746. Epub 2015 May 19.
- Deggouj N, Gersdorff M, Garin P, Castelein S, Gerard JM. Today's indications for cochlear implantation. B-ENT. 2007;3(1):9-14.
- Devocht EM, Dees G, Arts RA, Smits JJ, George EL, van Hoof M, Stokroos RJ. Revisiting Place-Pitch Match in CI Recipients Using 3D Imaging Analysis. Ann Otol Rhinol Laryngol. 2016 May;125(5):378-84. doi: 10.1177/0003489415616130. Epub 2015 Dec 1.
- Shannon RV, Zeng FG, Kamath V, Wygonski J, Ekelid M. Speech recognition with primarily temporal cues. Science. 1995 Oct 13;270(5234):303-4. doi: 10.1126/science.270.5234.303.
- Fu QJ, Shannon RV, Wang X. Effects of noise and spectral resolution on vowel and consonant recognition: acoustic and electric hearing. J Acoust Soc Am. 1998 Dec;104(6):3586-96. doi: 10.1121/1.423941.
- Munson B, Nelson PB. Phonetic identification in quiet and in noise by listeners with cochlear implants. J Acoust Soc Am. 2005 Oct;118(4):2607-17. doi: 10.1121/1.2005887.
- Rouger J, Lagleyre S, Fraysse B, Deneve S, Deguine O, Barone P. Evidence that cochlear-implanted deaf patients are better multisensory integrators. Proc Natl Acad Sci U S A. 2007 Apr 24;104(17):7295-300. doi: 10.1073/pnas.0609419104. Epub 2007 Apr 2.
- Rouger J, Fraysse B, Deguine O, Barone P. McGurk effects in cochlear-implanted deaf subjects. Brain Res. 2008 Jan 10;1188:87-99. doi: 10.1016/j.brainres.2007.10.049. Epub 2007 Oct 26.
- Marx M, James C, Foxton J, Capber A, Fraysse B, Barone P, Deguine O. Speech prosody perception in cochlear implant users with and without residual hearing. Ear Hear. 2015 Mar-Apr;36(2):239-48. doi: 10.1097/AUD.0000000000000105.
- Strelnikov K, Rouger J, Demonet JF, Lagleyre S, Fraysse B, Deguine O, Barone P. Does brain activity at rest reflect adaptive strategies? Evidence from speech processing after cochlear implantation. Cereb Cortex. 2010 May;20(5):1217-22. doi: 10.1093/cercor/bhp183. Epub 2009 Oct 5.
- Strelnikov K, Rouger J, Lagleyre S, Fraysse B, Demonet JF, Deguine O, Barone P. Increased audiovisual integration in cochlear-implanted deaf patients: independent components analysis of longitudinal positron emission tomography data. Eur J Neurosci. 2015 Mar;41(5):677-85. doi: 10.1111/ejn.12827.
- Rouger J, Lagleyre S, Demonet JF, Fraysse B, Deguine O, Barone P. Evolution of crossmodal reorganization of the voice area in cochlear-implanted deaf patients. Hum Brain Mapp. 2012 Aug;33(8):1929-40. doi: 10.1002/hbm.21331. Epub 2011 May 6.
- Giraud AL, Truy E, Frackowiak RS, Gregoire MC, Pujol JF, Collet L. Differential recruitment of the speech processing system in healthy subjects and rehabilitated cochlear implant patients. Brain. 2000 Jul;123 ( Pt 7):1391-402. doi: 10.1093/brain/123.7.1391.
- Giraud AL, Price CJ, Graham JM, Truy E, Frackowiak RS. Cross-modal plasticity underpins language recovery after cochlear implantation. Neuron. 2001 Jun;30(3):657-63. doi: 10.1016/s0896-6273(01)00318-x.
- Scheffler K, Bilecen D, Schmid N, Tschopp K, Seelig J. Auditory cortical responses in hearing subjects and unilateral deaf patients as detected by functional magnetic resonance imaging. Cereb Cortex. 1998 Mar;8(2):156-63. doi: 10.1093/cercor/8.2.156.
- Ponton CW, Vasama JP, Tremblay K, Khosla D, Kwong B, Don M. Plasticity in the adult human central auditory system: evidence from late-onset profound unilateral deafness. Hear Res. 2001 Apr;154(1-2):32-44. doi: 10.1016/s0378-5955(01)00214-3.
- Massida Z, Belin P, James C, Rouger J, Fraysse B, Barone P, Deguine O. Voice discrimination in cochlear-implanted deaf subjects. Hear Res. 2011 May;275(1-2):120-9. doi: 10.1016/j.heares.2010.12.010. Epub 2010 Dec 16.
- Guerreiro MJ, Erfort MV, Henssler J, Putzar L, Roder B. Increased visual cortical thickness in sight-recovery individuals. Hum Brain Mapp. 2015 Dec;36(12):5265-74. doi: 10.1002/hbm.23009. Epub 2015 Sep 29.
- Collett E, Marx M, Gaillard P, Roby B, Fraysse B, Deguine O, Barone P. Categorization of common sounds by cochlear implanted and normal hearing adults. Hear Res. 2016 May;335:207-219. doi: 10.1016/j.heares.2016.03.007. Epub 2016 Apr 2.
- Strelnikov K, Rouger J, Lagleyre S, Fraysse B, Deguine O, Barone P. Improvement in speech-reading ability by auditory training: Evidence from gender differences in normally hearing, deaf and cochlear implanted subjects. Neuropsychologia. 2009 Mar;47(4):972-9. doi: 10.1016/j.neuropsychologia.2008.10.017. Epub 2008 Oct 30.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- RC31/15/7797
- 2016-A01442-49 (Autre identifiant: ID-RCB)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
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