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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)

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ClinicalTrials.gov Identifier: NCT03117413
Recruitment Status : Recruiting
First Posted : April 18, 2017
Last Update Posted : December 3, 2018
Sponsor:
Collaborator:
Centre de recherche Cerveau et Cognition (CERCO)
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Profound Hearing Impairment Other: Positron emission tomography scan Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Subjects with asymmetric hearing loss treated with a cochlear implant and a control group of normal hearing subjects
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Positron Emission Tomography Imaging of Brain Reorganisation of the Central Auditory Cortex in Asymetrical Profound Deaf Patient With a Cochlear Implantation
Actual Study Start Date : November 23, 2017
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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)

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)




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03117413


Contacts
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Contact: Mathieu Marx, Pr 5 61 77 22 11 ext 33 marx.m@chu-toulouse.fr

Locations
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France
CERCO Active, not recruiting
Toulouse, Midi-Pyrénées, France, 31052
CHU de Toulouse - Hôpital Purpan Recruiting
Toulouse, France, 31059
Contact: Mathieu Marx, Pr    5 61 77 22 11 ext 33    marx.m@chu-toulouse.fr   
Principal Investigator: Mathieu Marx, Pr         
Sub-Investigator: Olivier Deguine, Pr         
Sub-Investigator: Bernard Fraysse, Pr         
Sponsors and Collaborators
University Hospital, Toulouse
Centre de recherche Cerveau et Cognition (CERCO)
Investigators
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Principal Investigator: Mathieu Marx, Pr CHU Toulouse

Publications:

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Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT03117413     History of Changes
Other Study ID Numbers: RC31/15/7797
2016-A01442-49 ( Other Identifier: ID-RCB )
First Posted: April 18, 2017    Key Record Dates
Last Update Posted: December 3, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Toulouse:
Cochlear implantation
Deafness
Auditory cortex
Auditory plasticity
Tinnitus
Additional relevant MeSH terms:
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Hearing Loss
Deafness
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms