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

April 29, 2026 updated by: University Hospital, Toulouse

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • France
      • Toulouse, France, France, 31059
        • CHU de Toulouse - Hôpital Purpan
    • Midi-Pyrénées
      • Toulouse, Midi-Pyrénées, France, 31052
        • CERCO

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Asymmetric hearing loss
Asymmetric hearing loss treated with a cochlear implant will undergo positron emission tomography scan.
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)
Other: Normal hearing subjects
Normal hearing subjects will undergo positron emission tomography scan.
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Day 1

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Toulouse

Collaborators

Centre de recherche Cerveau et Cognition (CERCO)

Investigators

  • Principal Investigator: Mathieu Marx, Pr, University Hospital, Toulouse

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 23, 2017

Primary Completion (Actual)

March 22, 2019

Study Completion (Actual)

March 22, 2019

Study Registration Dates

First Submitted

March 10, 2017

First Submitted That Met QC Criteria

April 11, 2017

First Posted (Actual)

April 18, 2017

Study Record Updates

Last Update Posted (Actual)

May 6, 2026

Last Update Submitted That Met QC Criteria

April 29, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC31/15/7797
  • 2016-A01442-49 (Other Identifier: ID-RCB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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