Positron Emission Tomography Imaging of Brain Reorganisation of the Central Auditory Cortex in Asymetrical Profound Deaf Patient With a Cochlear Implantation.

Profound Hearing Impairment Clinical Trial

— UniTEP  

Official title:

Positron Emission Tomography Imaging of Brain Reorganisation of the Central Auditory Cortex in Asymetrical Profound Deaf Patient With a Cochlear Implantation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03117413
• Other study ID #: RC31/15/7797
• Secondary ID: 2016-A01442-49
• Status: Completed
• Phase: N/A
• Start date: November 23, 2017
• Est. completion date: March 22, 2019

Study information

• Verified date: November 2020
• Source: University Hospital, Toulouse
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Our main objective is to study how the extent of reorganization of the central auditory system is related to the binaural integration in cochlear implanted subjects with asymmetric hearing loss. Subjects with asymmetric hearing loss treated with a cochlear implant and a control group of normal hearing subjects will perform two tests for binaural integration (speech recognition in noise and spatial localization) and two tasks of non-linguistic sounds perception.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 22, 2019
• Est. primary completion date: March 22, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Deafness
• Hearing Loss
• Profound Hearing Impairment

Intervention

Other:
• Positron emission tomography scan
Binaural hearing assessments: speech recognition in noise and sound source localization Voice perception assessment: voice/non-voice discrimination task, free categorization task Positron emission tomography examinations under ecological auditory stimuli (voice/non-voice discrimination task)

Locations

Country	Name	City	State
France	CERCO	Toulouse	Midi-Pyrénées
France	CHU de Toulouse - Hôpital Purpan	Toulouse

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Toulouse	Centre de recherche Cerveau et Cognition (CERCO)

Country where clinical trial is conducted

France, 

References & Publications (21)

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. — View Citation

Deggouj N, Gersdorff M, Garin P, Castelein S, Gérard JM. Today's indications for cochlear implantation. B-ENT. 2007;3(1):9-14. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Giraud AL, Truy E, Frackowiak RS, Grégoire 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. — View Citation

Guerreiro MJ, Erfort MV, Henssler J, Putzar L, Röder 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Rouger J, Fraysse B, Deguine O, Barone P. McGurk effects in cochlear-implanted deaf subjects. Brain Res. 2008 Jan 10;1188:87-99. Epub 2007 Oct 26. — View Citation

Rouger J, Lagleyre S, Démonet 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. — View Citation

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. Epub 2007 Apr 2. — View Citation

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. — View Citation

Shannon RV, Zeng FG, Kamath V, Wygonski J, Ekelid M. Speech recognition with primarily temporal cues. Science. 1995 Oct 13;270(5234):303-4. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Strelnikov K, Rouger J, Lagleyre S, Fraysse B, Démonet JF, Déguine 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. — View Citation

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. — View Citation

* Note: There are 21 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Differences in auditory brain activation between cochlear implanted asymmetric hearing loss subjects and normal hearing subjects in the binaural condition.	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.	Day 1
Secondary	differences in auditory brain activation.	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.	Week 3 - Week 5
Secondary	Performance level and the pattern of brain activation.	Acoustical or electrical stimulation in asymmetric hearing loss cochlear implanted subjects.	Week 3 - Week 5
Secondary	the asymmetry in auditory brain activation for asymmetric hearing loss cochlear implanted subjects.	Electrical and acoustical stimulation will be used.	Week 3 - Week 5
Secondary	link between binaural hearing performances and auditory brain activation in the binaural condition.	For the group of cochlear implanted subjects with asymmetric hearing loss.	Week 3 - Week 5