Positron Emission Tomography Imaging of Brain Reorganisation of the Central Auditory Cortex in Asymetrical Profound Deaf Patient With a Cochlear Implantation.
UniTEP
2 other identifiers
interventional
20
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Nov 2017
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 10, 2017
CompletedFirst Posted
Study publicly available on registry
April 18, 2017
CompletedStudy Start
First participant enrolled
November 23, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 22, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 22, 2019
CompletedMay 6, 2026
April 1, 2026
1.3 years
March 10, 2017
April 29, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
differences in auditory brain activation.
Week 3 - Week 5
Performance level and the pattern of brain activation.
Week 3 - Week 5
the asymmetry in auditory brain activation for asymmetric hearing loss cochlear implanted subjects.
Week 3 - Week 5
link between binaural hearing performances and auditory brain activation in the binaural condition.
Week 3 - Week 5
Study Arms (2)
Asymmetric hearing loss
OTHERAsymmetric hearing loss treated with a cochlear implant will undergo positron emission tomography scan.
Normal hearing subjects
OTHERNormal hearing subjects will undergo positron emission tomography scan.
Interventions
* 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)
Eligibility Criteria
You may qualify if:
- cochlear implantation\>3 months
- signature of informed consent
- affiliation to social service.
You may not qualify if:
- associated neurological disorder
- protected subjects
- epilepsy episodes
- psychotropic medication
- pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
CHU de Toulouse - Hôpital Purpan
Toulouse, France, 31059, France
CERCO
Toulouse, Midi-Pyrénées, 31052, France
Related Publications (4)
Karoui C, Strelnikov K, Payoux P, Salabert AS, James CJ, Deguine O, Barone P, Marx M. Auditory cortical plasticity after cochlear implantation in asymmetric hearing loss is related to spatial hearing: a PET H215O study. Cereb Cortex. 2023 Feb 20;33(5):2229-2244. doi: 10.1093/cercor/bhac204.
PMID: 35640270RESULTKaroui C, James C, Barone P, Bakhos D, Marx M, Macherey O. Searching for the Sound of a Cochlear Implant: Evaluation of Different Vocoder Parameters by Cochlear Implant Users With Single-Sided Deafness. Trends Hear. 2019 Jan-Dec;23:2331216519866029. doi: 10.1177/2331216519866029.
PMID: 31533581RESULTBerland A, Collett E, Gaillard P, Guidetti M, Strelnikov K, Cochard N, Barone P, Deguine O. Categorization of everyday sounds by cochlear implanted children. Sci Rep. 2019 Mar 5;9(1):3532. doi: 10.1038/s41598-019-39991-9.
PMID: 30837546RESULTStrelnikov K, Collett E, Gaillard P, Truy E, Deguine O, Marx M, Barone P. Categorisation of natural sounds at different stages of auditory recovery in cochlear implant adult deaf patients. Hear Res. 2018 Sep;367:182-194. doi: 10.1016/j.heares.2018.06.006. Epub 2018 Jun 12.
PMID: 29914727RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mathieu Marx, Pr
University Hospital, Toulouse
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 10, 2017
First Posted
April 18, 2017
Study Start
November 23, 2017
Primary Completion
March 22, 2019
Study Completion
March 22, 2019
Last Updated
May 6, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share