Profound Hearing ImpairmentUniTEPNCT03117413
Positron Emission Tomography Imaging of Brain Reorganisation of the Central Auditory Cortex in Asymetrical Profound Deaf Patient With a Cochlear Implantation.
A study testing Positron emission tomography scan in people with Profound Hearing Impairment, run by University Hospital, Toulouse at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Profound Hearing Impairment
- What is being tested?
- Positron emission tomography scan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesFrance
- Study dates
- 23 Nov 2017to 22 Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- cochlear implantation>3 months
- signature of informed consent
- affiliation to social service.
Who cannot join
- associated neurological disorder
- protected subjects
- epilepsy episodes
- psychotropic medication
- pregnancy
Trial locations and contacts
2 sites in 1 country.
France2 sites
CHU de Toulouse - Hôpital Purpan
Toulouse, France, 31059
CERCO
Toulouse, Midi-Pyrénées, 31052
About this study
Official title: 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.
Read the 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.
- Conditions
- Profound Hearing Impairment
- Being tested
- Positron emission tomography scan
- Keywords
- Cochlear implantation, Deafness, Auditory cortex, Auditory plasticity, Tinnitus
- Medical subject headings
- Deafness, Tinnitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Positron emission tomography scanOther
- 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)
| Study group | Role | What they receive |
|---|---|---|
| Asymmetric hearing loss | Other | Asymmetric hearing loss treated with a cochlear implant will undergo positron emission tomography scan. Receives: Other: Positron emission tomography scan |
| Normal hearing subjects | Other | Normal hearing subjects will undergo positron emission tomography scan. Receives: Other: Positron emission tomography scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1
Secondary outcomes (4)
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.
Measured: Week 3 - Week 5
Performance level and the pattern of brain activation.
Acoustical or electrical stimulation in asymmetric hearing loss cochlear implanted subjects.
Measured: Week 3 - Week 5
the asymmetry in auditory brain activation for asymmetric hearing loss cochlear implanted subjects.
Electrical and acoustical stimulation will be used.
Measured: Week 3 - Week 5
link between binaural hearing performances and auditory brain activation in the binaural condition.
For the group of cochlear implanted subjects with asymmetric hearing loss.
Measured: Week 3 - Week 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2017
- Study start23 Nov 2017
- Primary completion22 Mar 2019
- Study completion22 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Profound Hearing ImpairmentStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Subjects with asymmetric hearing loss treated with a cochlear implant and a control group of normal hearing subjects
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Collaborators
- Centre de recherche Cerveau et Cognition (CERCO)
- Responsible party
- Sponsor
- Investigators
- Mathieu Marx, Pr, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03117413
- Sponsor's protocol ID
- RC31/15/7797
- Other IDs
- 2016-A01442-49
- Acronym
- UniTEP
- Status last verified
- Apr 2026
- First submitted
- 10 Mar 2017
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Karoui C, Strelnikov K, Payoux P, Salabert AS, James CJ, Deguine O, Barone P, Marx M. Auditory cortical plasticity after cochlear implantation in asymmetric hearing loss is related to spatial hearing: a PET H215O study. Cereb Cortex. 2023 Feb 20;33(5):2229-2244. doi: 10.1093/cercor/bhac204.
PubMed 35640270Karoui C, James C, Barone P, Bakhos D, Marx M, Macherey O. Searching for the Sound of a Cochlear Implant: Evaluation of Different Vocoder Parameters by Cochlear Implant Users With Single-Sided Deafness. Trends Hear. 2019 Jan-Dec;23:2331216519866029. doi: 10.1177/2331216519866029.
PubMed 31533581Berland A, Collett E, Gaillard P, Guidetti M, Strelnikov K, Cochard N, Barone P, Deguine O. Categorization of everyday sounds by cochlear implanted children. Sci Rep. 2019 Mar 5;9(1):3532. doi: 10.1038/s41598-019-39991-9.
PubMed 30837546Strelnikov K, Collett E, Gaillard P, Truy E, Deguine O, Marx M, Barone P. Categorisation of natural sounds at different stages of auditory recovery in cochlear implant adult deaf patients. Hear Res. 2018 Sep;367:182-194. doi: 10.1016/j.heares.2018.06.006. Epub 2018 Jun 12.
PubMed 29914727
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Positron Emission Tomography Imaging of Brain Reorganisation of the Central Auditory Cortex in Asymetrical Profound Deaf Patient With a Cochlear Implantation
- ClinicalTrials.gov ID
- NCT03117413
- Acronym / sponsor ID
- UniTEP / RC31/15/7797
- Conditions
- Profound Hearing Impairment
- Keywords
- Cochlear implantation, Deafness, Auditory cortex, Auditory plasticity, Tinnitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Collaborators
- Centre de recherche Cerveau et Cognition (CERCO)
- Study start
- 23 Nov 2017 (actual)
- Primary completion
- 22 Mar 2019 (actual)
- Study completion
- 22 Mar 2019 (actual)
- First posted
- 18 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Subjects with asymmetric hearing loss treated with a cochlear implant and a control group of normal hearing subjects
| Arm | Type | Receives |
|---|---|---|
| Asymmetric hearing loss | Other | Other: Positron emission tomography scanAsymmetric hearing loss treated with a cochlear implant will undergo positron emission tomography scan. |
| Normal hearing subjects | Other | Other: Positron emission tomography scanNormal hearing subjects will undergo positron emission tomography scan. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- cochlear implantation>3 months
- signature of informed consent
- affiliation to social service.
Key exclusion criteria (5 listed)
- associated neurological disorder
- protected subjects
- epilepsy episodes
- psychotropic medication
- pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Asymmetric hearing loss, Normal hearing subjects |
Primary outcome
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.
4 secondary outcomes
differences in auditory brain activation.
Time frame: Week 3 - Week 5
Performance level and the pattern of brain activation.
Time frame: Week 3 - Week 5
the asymmetry in auditory brain activation for asymmetric hearing loss cochlear implanted subjects.
Time frame: Week 3 - Week 5
link between binaural hearing performances and auditory brain activation in the binaural condition.
Time frame: Week 3 - Week 5
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Results publication: PubMed 35640270Karoui C, Strelnikov K, Payoux P, Salabert AS, James CJ, Deguine O, Barone P, Marx M. Auditory cortical plasticity after cochlear implantation in asymmetric hearing loss is related to spatial hearing: a PET H215O study. Cereb Cortex. 2023 Feb 20;33(5):2229-2244. doi: 10.1093/cercor/bhac204.
- Results publication: PubMed 31533581Karoui C, James C, Barone P, Bakhos D, Marx M, Macherey O. Searching for the Sound of a Cochlear Implant: Evaluation of Different Vocoder Parameters by Cochlear Implant Users With Single-Sided Deafness. Trends Hear. 2019 Jan-Dec;23:2331216519866029. doi: 10.1177/2331216519866029.
- Results publication: PubMed 30837546Berland A, Collett E, Gaillard P, Guidetti M, Strelnikov K, Cochard N, Barone P, Deguine O. Categorization of everyday sounds by cochlear implanted children. Sci Rep. 2019 Mar 5;9(1):3532. doi: 10.1038/s41598-019-39991-9.
- Results publication: PubMed 29914727Strelnikov K, Collett E, Gaillard P, Truy E, Deguine O, Marx M, Barone P. Categorisation of natural sounds at different stages of auditory recovery in cochlear implant adult deaf patients. Hear Res. 2018 Sep;367:182-194. doi: 10.1016/j.heares.2018.06.006. Epub 2018 Jun 12.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mathieu Marx, Pr principal investigator
University Hospital, Toulouse
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Positron emission tomography scan in people with Profound Hearing Impairment, run by University Hospital, Toulouse at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differences in auditory brain activation between cochlear implanted asymmetric hearing loss subjects and normal hearing subjects in the binaural condition. (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03117413, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.