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

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое neurophysiological assessment
  Electroencephalography and eye tracking
• Поведенческое 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).

Первичные конечные точки

• Evolution of oscillatory signatures [Срок оценки: 6 months]

Вторичные конечные точки (5)

• EEG (alpha) signatures and eye-tracking [Срок оценки: 6 months]
• Speech recognition performance [Срок оценки: 6 months]
• alpha modulation and memory/auditory [Срок оценки: 6 months]
• audiovisual, visual and auditory comparison [Срок оценки: 6 months]
• SSQ [Срок оценки: 6 months]

Критерии участия

Критерии включения

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.

Критерии исключения

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Другое

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07500909 · RC31/26/0005 · 2026-A00163-48

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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