Clinical trial NCT03117413: Positron Emission Tomography Imaging of Brain Reorganisation of the Central Auditory Cortex in Asymetrical Profound Deaf Patient With a Cochlear Implantation.
Official title: Positron Emission Tomography Imaging of Brain Reorganisation of the Central Auditory Cortex in Asymetrical Profound Deaf Patient With a Cochlear Implantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Profound Hearing Impairment
Keywords: Cochlear implantation
Deafness
Auditory cortex
Auditory plasticity
Tinnitus
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
Collaborators: name: Centre de recherche Cerveau et Cognition (CERCO)
First posted: 2017-04-18
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Subjects with asymmetric hearing loss treated with a cochlear implant and a control group of normal hearing subjects
Primary purpose: BASIC_SCIENCE

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Differences in auditory brain activation between cochlear implanted asymmetric hearing loss subjects and normal hearing subjects in the binaural condition.
timeFrame: Day 1
Secondary outcomes:
measure: differences in auditory brain activation.
timeFrame: Week 3 - Week 5
measure: Performance level and the pattern of brain activation.
timeFrame: Week 3 - Week 5
measure: the asymmetry in auditory brain activation for asymmetric hearing loss cochlear implanted subjects.
timeFrame: Week 3 - Week 5
measure: link between binaural hearing performances and auditory brain activation in the binaural condition.
timeFrame: Week 3 - Week 5
Other outcomes:
Locations:
city: Toulouse
country: France
facility: CERCO
state: Midi-Pyrénées
city: Toulouse
country: France
facility: CHU de Toulouse - Hôpital Purpan
Study officials:
affiliation: CHU Toulouse
name: Mathieu Marx, Pr
role: PRINCIPAL_INVESTIGATOR
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