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Clinical Trials/NCT03117413
NCT03117413CompletedNot Applicable

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

University Hospital, Toulouse4 sites in 1 country20 target enrollmentStarted: November 23, 2017Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
20
Locations
4
Primary Endpoint
Differences in auditory brain activation between cochlear implanted asymmetric hearing loss subjects and normal hearing subjects in the binaural condition.

Study Overview

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 Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Basic Science
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

Asymmetric hearing loss

Other

Asymmetric hearing loss treated with a cochlear implant will undergo positron emission tomography scan.

Intervention: Positron emission tomography scan (Other)

Normal hearing subjects

Other

Normal hearing subjects will undergo positron emission tomography scan.

Intervention: Positron emission tomography scan (Other)

Outcomes

Primary Outcomes

Differences in auditory brain activation between cochlear implanted asymmetric hearing loss subjects and normal hearing subjects in the binaural condition.

Time Frame: 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 Outcomes

  • 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)
  • differences in auditory brain activation.(Week 3 - Week 5)
  • link between binaural hearing performances and auditory brain activation in the binaural condition.(Week 3 - Week 5)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (4)

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