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

Primary Purpose

Profound Hearing Impairment

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Positron emission tomography scan
Sponsored by
University Hospital, Toulouse
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Profound Hearing Impairment focused on measuring Cochlear implantation, Deafness, Auditory cortex, Auditory plasticity, Tinnitus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • CERCO
  • CHU de Toulouse - Hôpital Purpan

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Asymmetric hearing loss

Normal hearing subjects

Arm Description

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

Normal hearing subjects will undergo positron emission tomography scan.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
March 10, 2017
Last Updated
November 10, 2020
Sponsor
University Hospital, Toulouse
Collaborators
Centre de recherche Cerveau et Cognition (CERCO)
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1. Study Identification

Unique Protocol Identification Number
NCT03117413
Brief Title
Positron Emission Tomography Imaging of Brain Reorganisation of the Central Auditory Cortex in Asymetrical Profound Deaf Patient With a Cochlear Implantation.
Acronym
UniTEP
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

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
November 23, 2017 (Actual)
Primary Completion Date
March 22, 2019 (Actual)
Study Completion Date
March 22, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Toulouse
Collaborators
Centre de recherche Cerveau et Cognition (CERCO)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Profound Hearing Impairment
Keywords
Cochlear implantation, Deafness, Auditory cortex, Auditory plasticity, Tinnitus

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Subjects with asymmetric hearing loss treated with a cochlear implant and a control group of normal hearing subjects
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Asymmetric hearing loss
Arm Type
Other
Arm Description
Asymmetric hearing loss treated with a cochlear implant will undergo positron emission tomography scan.
Arm Title
Normal hearing subjects
Arm Type
Other
Arm Description
Normal hearing subjects will undergo positron emission tomography scan.
Intervention Type
Other
Intervention Name(s)
Positron emission tomography scan
Intervention Description
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)
Primary Outcome Measure Information:
Title
Differences in auditory brain activation between cochlear implanted asymmetric hearing loss subjects and normal hearing subjects in the binaural condition.
Description
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.
Time Frame
Day 1
Secondary Outcome Measure Information:
Title
differences in auditory brain activation.
Description
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.
Time Frame
Week 3 - Week 5
Title
Performance level and the pattern of brain activation.
Description
Acoustical or electrical stimulation in asymmetric hearing loss cochlear implanted subjects.
Time Frame
Week 3 - Week 5
Title
the asymmetry in auditory brain activation for asymmetric hearing loss cochlear implanted subjects.
Description
Electrical and acoustical stimulation will be used.
Time Frame
Week 3 - Week 5
Title
link between binaural hearing performances and auditory brain activation in the binaural condition.
Description
For the group of cochlear implanted subjects with asymmetric hearing loss.
Time Frame
Week 3 - Week 5

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mathieu Marx, Pr
Organizational Affiliation
CHU Toulouse
Official's Role
Principal Investigator
Facility Information:
Facility Name
CERCO
City
Toulouse
State/Province
Midi-Pyrénées
ZIP/Postal Code
31052
Country
France
Facility Name
CHU de Toulouse - Hôpital Purpan
City
Toulouse
ZIP/Postal Code
31059
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
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Positron Emission Tomography Imaging of Brain Reorganisation of the Central Auditory Cortex in Asymetrical Profound Deaf Patient With a Cochlear Implantation.

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