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

Not Applicable

Completed

• Conditions: Profound Hearing Impairment
• Interventions: Other: Positron emission tomography scan

• Registration Number: NCT03117413
• Lead Sponsor: University Hospital, Toulouse

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.

Study Timeline

• Study First Submitted: 2017-03-10
• Study First Submitted QC: 2017-04-11
• Study First Posted: 2017-04-18
• Study Start: 2017-11-23
• Primary Completion: 2019-03-22
• Study Completion: 2019-03-22
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-10
• Last Update Posted: 2020-11-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Normal hearing subjects	Positron emission tomography scan	Normal hearing subjects will undergo positron emission tomography scan.
Asymmetric hearing loss	Positron emission tomography scan	Asymmetric hearing loss treated with a cochlear implant will undergo positron emission tomography scan.

Primary Outcome Measures

Name	Time	Method
Differences in auditory brain activation between cochlear implanted asymmetric hearing loss subjects and normal hearing subjects in the binaural condition.	Day 1	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.

Secondary Outcome Measures

Name	Time	Method
Performance level and the pattern of brain activation.	Week 3 - Week 5	Acoustical or electrical stimulation in asymmetric hearing loss cochlear implanted subjects.
the asymmetry in auditory brain activation for asymmetric hearing loss cochlear implanted subjects.	Week 3 - Week 5	Electrical and acoustical stimulation will be used.
differences in auditory brain activation.	Week 3 - Week 5	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.
link between binaural hearing performances and auditory brain activation in the binaural condition.	Week 3 - Week 5	For the group of cochlear implanted subjects with asymmetric hearing loss.

Trial Locations

Locations (2)

CERCO; 🇫🇷 Toulouse, Midi-Pyrénées, France

CHU de Toulouse - Hôpital Purpan; 🇫🇷 Toulouse, France