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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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07500909
Acronym
REASCENT
Enrollment
90
Registered
2026-03-30
Start date
2026-03-01
Completion date
2029-03-01
Last updated
2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Deafness, Bilateral

Keywords

electroencephalographic, top-down processes, sensory loss, deaf, cochlear implant

Brief 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 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

Electroencephalography and eye tracking

BEHAVIORALCognitive, 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).

Sponsors

University Hospital, Toulouse
Lead SponsorOTHER
Centre de recherche Cerveau et Cognition (CERCO)
CollaboratorUNKNOWN

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frameDescription
Evolution of oscillatory signatures6 monthsComposite 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.

Secondary

MeasureTime frameDescription
EEG (alpha) signatures and eye-tracking6 monthsDescriptive evaluation : Evolution of EEG (alpha) signatures and eye-tracking trajectories (composite criterion)
Speech recognition performance6 monthsSpeech recognition performance (MBAA, accuracy, response time) in silence and noise : Composite criterion
alpha modulation and memory/auditory6 monthsCorrelations between alpha modulation and memory/auditory performance : Descriptive evaluation
audiovisual, visual and auditory comparison6 monthsThe comparison between audiovisual, visual and auditory modalitie (descriptive evaluation)
SSQ6 monthsThis 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).

Contacts

CONTACTMathieu MARX, Pr
marx.m@chu-toulouse.fr05 61 77 77 04
CONTACTFlorine LEGAY
legay.f@chu-toulouse.fr+33 5 61 77 82 04
PRINCIPAL_INVESTIGATORMathieu MARX, PU-PH

University Hospital, Toulouse

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 31, 2026