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NCT Number: NCT07500909

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

neurophysiological assessment

Other

Electroencephalography and eye tracking

Cognitive, behavioral and quality of life assessment

Behavioral

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 outcomes

  1. 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.

Secondary outcomes

  1. EEG (alpha) signatures and eye-tracking

    Time frame: 6 months

    Descriptive evaluation : Evolution of EEG (alpha) signatures and eye-tracking trajectories (composite criterion)

  2. Speech recognition performance

    Time frame: 6 months

    Speech recognition performance (MBAA, accuracy, response time) in silence and noise : Composite criterion

  3. alpha modulation and memory/auditory

    Time frame: 6 months

    Correlations between alpha modulation and memory/auditory performance : Descriptive evaluation

  4. audiovisual, visual and auditory comparison

    Time frame: 6 months

    The comparison between audiovisual, visual and auditory modalitie (descriptive evaluation)

  5. SSQ

    Time frame: 6 months

    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 contacts

Contact information is provided by the study sponsor or research team.

Florine LEGAY

CONTACT

[email protected]

+33 5 61 77 82 04

Mathieu MARX, Pr

CONTACT

[email protected]

05 61 77 77 04

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Collaborators

  • Centre de recherche Cerveau et Cognition (CERCO)

Registry information

Acronym: REASCENT

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Mar 30, 2026
Registry last updated
Mar 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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