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
|Condition or disease||Intervention/treatment||Phase|
|Profound Hearing Impairment||Other: Positron emission tomography scan||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|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|
Asymmetric hearing loss
Asymmetric hearing loss treated with a cochlear implant will undergo positron emission tomography scan.
Other: Positron emission tomography scan
Normal hearing subjects
Normal hearing subjects will undergo positron emission tomography scan.
Other: Positron emission tomography scan
- 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.
- 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.
- 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.
- 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.
- 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.
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
|Contact: Mathieu Marx, Pr||5 61 77 22 11 ext email@example.com|
|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 firstname.lastname@example.org|
|Principal Investigator: Mathieu Marx, Pr|
|Sub-Investigator: Olivier Deguine, Pr|
|Sub-Investigator: Bernard Fraysse, Pr|
|Principal Investigator:||Mathieu Marx, Pr||CHU Toulouse|