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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: neurophysiological assessment, Cognitive, behavioral and quality of life assessment.
- Who it may be relevant to
- Registry conditions: Deafness, Bilateral. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Other neurophysiological assessment
Electroencephalography and eye tracking - Behavioral Cognitive, behavioral and quality of life assessment
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).
Primary outcome measures
- Evolution of oscillatory signatures [Time frame: 6 months]
Secondary outcome measures (5)
- 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]
Eligibility criteria
Inclusion criteria
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
- 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.
Exclusion criteria
- 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
- 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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Other
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07500909 · RC31/26/0005 · 2026-A00163-48