Deafness, BilateralREASCENTNCT07500909
Study of the Role of Top-down Processes in Neuronal Reorganization and Recovery From Sensory Loss: an Exploratory Behavioral and Electroencephalographic Study in Cochlear-supported Deaf Patients
An observational study of Deafness, Bilateral, run by University Hospital, Toulouse.
Trial summary
This study posits that central top-down processes (attention, inhibition), marked by alpha oscillations in EEG, play a key role. Understanding the evolution of these neuronal signatures and their link to pre-implantation visual dependence could allow the identification of biomarkers predictive of the success of… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Deafness, Bilateral
- What is being tested?
- neurophysiological assessment and Cognitive, behavioral and quality of life assessment
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2026to 1 Mar 2029
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: Participants with cochlear implants will be informed about this study during a routine check-up at the partner hearing aid laboratory (Audial), or by the ENT department at Purpan Hospital during a consultation as part of patient follow-up. All participants with normal hearing (young and old) will be recruited through announcements made to members of the ENT department and the CerCo UMR 5549 laboratory.
Who may be able to join
- For cochlear implant patients:
- Adult patients
- Profound bilateral hearing loss requiring a first cochlear implant
- Normal cochlear anatomy (confirmed by preoperative imaging)
- Full insertion of the cochlear electrode array planned
- Acceptance of the protocol and signing of the informed consent form
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- Enrollment in a social security or equivalent plan
- For young patients with normal hearing:
- Adult patients aged 18 to 40
- Normal and symmetrical hearing
- Acceptance of the protocol and signature of the informed consent form
- Affiliation with a social security scheme or equivalent
- For older patients with normal hearing:
- Patients over 50 years of age, matched by gender and age (+/- 2 years) with the cochlear implant patient group
- Normal and symmetrical hearing, with hearing thresholds < 20 dB HL at 2 kHz and < 40 dB HL at 4 kHz
- Acceptance of the protocol and signature of the informed consent form
- Affiliation with a social security scheme or equivalent
- For experienced cochlear implant recipients:
- Adult patients.
- Unilateral cochlear implant activated for 1 year or more.
- Disyllabic word recognition score at 60 dB in free field of 70% or higher.
- Acceptance of the protocol and signature of the informed consent form.
- Affiliation with a social security plan or equivalent.
- For severely deaf patients fitted with hearing aids:
- Adult patients.
- Severe bilateral hearing loss.
- Rehabilitation with one or two optimally fitted hearing aids.
- Acceptance of the protocol and signing of the informed consent form.
- Enrollment in a social security or equivalent health insurance plan.
Who cannot join
- History of associated neurological pathology
- Etiologies with unfavorable prognoses, such as recurrent chronic otitis media: These conditions are associated with a poor prognosis due to chronic inflammation that can affect the cochlea
- Duration of profound bilateral deafness exceeding 5 years (worse prognosis)
- Contraindications to EEG or other neurophysiological examinations within the study (for all groups)
- Cognitive impairment confirmed by the MOCA test for the cochlear implant patient group and the group of elderly subjects with normal hearing
- Use of psychotropic medications that may interfere with the results of cognitive or neurological tests
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- History of epilepsy or other major neurological disorders
- Pregnancy or breastfeeding
- Participation in another interventional research protocol or one that impacts the criteria studied in this project
- Individuals under legal guardianship (guardianship, tutorship, curatorship, institutionalized, or under a future protection mandate)
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
This study posits that central top-down processes (attention, inhibition), marked by alpha oscillations in EEG, play a key role. Understanding the evolution of these neuronal signatures and their link to pre-implantation visual dependence could allow the identification of biomarkers predictive of the success of auditory rehabilitation.
Read the detailed description
Profound bilateral deafness leads to sensory deprivation and neuronal reorganization ( visual recruitment of the auditory cortex). Although cochlear implants restore hearing, comprehension performance varies considerably. Peripheral factors explain only 40% of this variance. This study posits that central top-down processes (attention, inhibition), marked by alpha oscillations in EEG, play a key role. Understanding the evolution of these neuronal signatures and their link to pre-implantation visual dependence could allow the identification of biomarkers predictive of the success of auditory rehabilitation.
- Conditions
- Deafness, Bilateral
- Being tested
- neurophysiological assessment, Cognitive, behavioral and quality of life assessment
- Keywords
- electroencephalographic, top-down processes, sensory loss, deaf, cochlear implant
- Medical subject headings
- Hearing Loss, Bilateral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
neurophysiological assessmentOther
Electroencephalography and eye tracking
Cognitive, behavioral and quality of life assessmentBehavioural
Cognitive anfd behavioral assessment : Speech recognition test in silence (MBAA) and in noise, verbal working memory task with distractors, Trail Making Test and MoCA test.
Quality of lige assessment : This questionnaire is a set of scales concerning patients' hearing abilities, experience, and listening skills in different situations. For each question, the patient must answer by choosing a number between 1 (not at all) and 10 (perfectly).
| Study group | Role | What they receive |
|---|---|---|
| Group of cochlear implant patients | This group consists of adult patients with profound bilateral hearing loss, candidates for a first unilateral cochlear implant, and meeting the specific inclusion criteria. Receives: Other: neurophysiological assessment; Behavioral: Cognitive, behavioral and quality of life assessment | |
| Group of young, normally hearing subjects | This control group consists of healthy young adult subjects (18-40 years old) with normal and symmetrical hearing confirmed by audiometry. Receives: Other: neurophysiological assessment; Behavioral: Cognitive, behavioral and quality of life assessment | |
| Group of normally hearing elderly subjects matched for gender and age | This control group consists of healthy older adults (> 50 years) with age-appropriate hearing (thresholds defined in the inclusion criteria) confirmed by audiometry. They are matched by age (+/- 2 years) and gender with the cochlear implant patient group. Receives: Other: neurophysiological assessment; Behavioral: Cognitive, behavioral and quality of life assessment | |
| Group of experienced cochlear implant patients | This control group consists of adult patients using a unilateral cochlear implant for at least one year and exhibiting good hearing performance (≥70% word recognition). Receives: Other: neurophysiological assessment; Behavioral: Cognitive, behavioral and quality of life assessment | |
| Group of hearing-equipped deaf patients | This control group consists of adult patients with severe bilateral deafness who have been rehabilitated with optimally fitted hearing aids. Receives: Other: neurophysiological assessment; Behavioral: Cognitive, behavioral and quality of life assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evolution of oscillatory signatures
Composite criterion :the modulation of alpha oscillations, measured through frequency analysis, amplitude variations and temporal synchronization via EEG, in response to a word recognition task in silence.
Measured: 6 months
Secondary outcomes (5)
EEG (alpha) signatures and eye-tracking
Descriptive evaluation : Evolution of EEG (alpha) signatures and eye-tracking trajectories (composite criterion)
Measured: 6 months
Speech recognition performance
Speech recognition performance (MBAA, accuracy, response time) in silence and noise : Composite criterion
Measured: 6 months
alpha modulation and memory/auditory
Correlations between alpha modulation and memory/auditory performance : Descriptive evaluation
Measured: 6 months
audiovisual, visual and auditory comparison
The comparison between audiovisual, visual and auditory modalitie (descriptive evaluation)
Measured: 6 months
SSQ
This questionnaire is a set of scales concerning patients' hearing abilities, experience, and listening skills in different situations. For each question, the patient must answer by choosing a number between 1 (not at all) and 10 (perfectly).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2026
- Study start1 Mar 2026 (estimated)
- Primary completion1 Mar 2029 (estimated)
- Study completion1 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Deafness, BilateralStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
- Target duration
- 6 Months
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, PU-PH, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07500909
- Sponsor's protocol ID
- RC31/26/0005
- Other IDs
- 2026-A00163-48
- Acronym
- REASCENT
- Status last verified
- Mar 2026
- First submitted
- 24 Mar 2026
- Last updated
- 30 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Role of Top-down Processes in Neuronal Reorganization and Recovery From Sensory Loss: an Exploratory Behavioral and Electroencephalographic Study in Cochlear-supported Deaf Patients
- ClinicalTrials.gov ID
- NCT07500909
- Acronym / sponsor ID
- REASCENT / RC31/26/0005
- Conditions
- Deafness, Bilateral
- Keywords
- electroencephalographic, top-down processes, sensory loss, deaf, cochlear implant
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Collaborators
- Centre de recherche Cerveau et Cognition (CERCO)
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- 1 Mar 2029 (estimated)
- Study completion
- 1 Mar 2029 (estimated)
- First posted
- 30 Mar 2026 (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.
This study posits that central top-down processes (attention, inhibition), marked by alpha oscillations in EEG, play a key role. Understanding the evolution of these neuronal signatures and their link to pre-implantation visual dependence could allow the identification of biomarkers predictive of the success of auditory rehabilitation.
Detailed description
Profound bilateral deafness leads to sensory deprivation and neuronal reorganization ( visual recruitment of the auditory cortex). Although cochlear implants restore hearing, comprehension performance varies considerably. Peripheral factors explain only 40% of this variance. This study posits that central top-down processes (attention, inhibition), marked by alpha oscillations in EEG, play a key role. Understanding the evolution of these neuronal signatures and their link to pre-implantation visual dependence could allow the identification of biomarkers predictive of the success of auditory rehabilitation.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Group of cochlear implant patients | – | Other: neurophysiological assessment, Behavioral: Cognitive, behavioral and quality of life assessmentThis group consists of adult patients with profound bilateral hearing loss, candidates for a first unilateral cochlear implant, and meeting the specific inclusion criteria. |
| Group of young, normally hearing subjects | – | Other: neurophysiological assessment, Behavioral: Cognitive, behavioral and quality of life assessmentThis control group consists of healthy young adult subjects (18-40 years old) with normal and symmetrical hearing confirmed by audiometry. |
| Group of normally hearing elderly subjects matched for gender and age | – | Other: neurophysiological assessment, Behavioral: Cognitive, behavioral and quality of life assessmentThis control group consists of healthy older adults (> 50 years) with age-appropriate hearing (thresholds defined in the inclusion criteria) confirmed by audiometry. They are matched by age (+/- 2 years) and gender with the cochlear implant patient group. |
| Group of experienced cochlear implant patients | – | Other: neurophysiological assessment, Behavioral: Cognitive, behavioral and quality of life assessmentThis control group consists of adult patients using a unilateral cochlear implant for at least one year and exhibiting good hearing performance (≥70% word recognition). |
| Group of hearing-equipped deaf patients | – | Other: neurophysiological assessment, Behavioral: Cognitive, behavioral and quality of life assessmentThis control group consists of adult patients with severe bilateral deafness who have been rehabilitated with optimally fitted hearing aids. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants with cochlear implants will be informed about this study during a routine check-up at the partner hearing aid laboratory (Audial), or by the ENT department at Purpan Hospital during a consultation as part of patient follow-up. All participants with normal hearing (young and old) will be recruited through announcements made to members of the ENT department and the CerCo UMR 5549 laboratory.
Key inclusion criteria (29 listed)
- Adult patients
- Profound bilateral hearing loss requiring a first cochlear implant
- Normal cochlear anatomy (confirmed by preoperative imaging)
- Full insertion of the cochlear electrode array planned
- Acceptance of the protocol and signing of the informed consent form
Key exclusion criteria (10 listed)
- History of associated neurological pathology
- Etiologies with unfavorable prognoses, such as recurrent chronic otitis media: These conditions are associated with a poor prognosis due to chronic inflammation that can affect the cochlea
- Duration of profound bilateral deafness exceeding 5 years (worse prognosis)
- Contraindications to EEG or other neurophysiological examinations within the study (for all groups)
- Cognitive impairment confirmed by the MOCA test for the cochlear implant patient group and the group of elderly subjects with normal hearing
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 |
|---|---|---|
| neurophysiological assessmentElectroencephalography and eye tracking | Other | Group of cochlear implant patients, Group of experienced cochlear implant patients, Group of hearing-equipped deaf patients, Group of normally hearing elderly subjects matched for gender and age, Group of young, normally hearing subjects |
| Cognitive, behavioral and quality of life assessmentCognitive anfd behavioral assessment : Speech recognition test in silence (MBAA) and in noise, verbal working memory task with distractors, Trail Making Test and MoCA test. Quality of lige assessment : This questionnaire is a set of scales concerning patients' hearing abilities, experience, and listening skills in different situations. For each question, the patient must answer by choosing a number between 1 (not at all) and 10 (perfectly). | Behavioural | Group of cochlear implant patients, Group of experienced cochlear implant patients, Group of hearing-equipped deaf patients, Group of normally hearing elderly subjects matched for gender and age, Group of young, normally hearing subjects |
Primary outcome
Evolution of oscillatory signatures
Time frame: 6 months
Composite criterion :the modulation of alpha oscillations, measured through frequency analysis, amplitude variations and temporal synchronization via EEG, in response to a word recognition task in silence.
5 secondary outcomes
EEG (alpha) signatures and eye-tracking
Time frame: 6 months
Speech recognition performance
Time frame: 6 months
alpha modulation and memory/auditory
Time frame: 6 months
audiovisual, visual and auditory comparison
Time frame: 6 months
SSQ
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2026.
- 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.
Mathieu MARX, PU-PH principal investigator
University Hospital, Toulouse
Questions about this trial
What is this clinical trial studying?
An observational study of Deafness, Bilateral, run by University Hospital, Toulouse.
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 29 inclusion and 10 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: opening soon, as of the sponsor's last update on 30 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mathieu MARX, Pr (05 61 77 77 04, marx.m@chu-toulouse.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evolution of oscillatory signatures (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Mar 2026.