Neurophysiological Measures of Auditory Perception and Rehabilitation in Cochlear Implanted Patients

Hospices Civils de Lyon91 enrolled

Overview

This study aims at investigating new automatic fitting techniques for cochlear implant patients based on objective measures. For this reason, the evolution of these neurophysiological measures, expressing the encoding of pure tones and speech, will be characterized in cochlear implanted patients as a function of post-implantation time and will be compared to those of normal hearing subjects. Moreover, the effect of auditory training with new tools based on serious games will be assessed.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Deafness

Interventions

Auditory steady-state response ASSROTHER

comparison of ASSR amplitudes in response to amplitude-modulated sounds delivered at different intensities

Speech-ABROTHER

Acoustic Change Complex ACCOTHER

comparison of ACC complex in response to changes within speech stimulation

Eligibility

Sex: ALLMin age: 1 YearMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * native French speaker * no medical treatment for behavior or neurological disorders * normal or corrected vision * right-handed * normal ORL examination * valid affiliation to social security * absence of participation to another study For the cochlear implanted patients: * aged from 1 to 70 * bilateral severe to profound deafness * cochlear implant * congenital deafness, pre or post lingual For the normal-hearing subjects: * Aged from 18 to 70 * Normal tonal audiometry Exclusion Criteria: * No signed consent * Treatment for depression, epilepsy, Parkinson's or Alzheimer's disease * Physical health deficiency * Mental retardation * Neurological or psychiatric disease incompatible with the testing procedure * Schooling in a foreign language * Foreign language spoken at home with both parents * Invalid social security * For the normal hearing subjects, no known hearing deficits

Locations (1)

Hospices Civils de Lyon - Hopital Edouard Herriot

Lyon, France

Outcomes

Primary Outcomes

Amplitude of auditory steady state responses ASSR

Time frame: one year at least after CI activation

Spectro-temporal analysis of speech-ABR

Time frame: one year at least after CI activation

Acoustic Change Complex ACC

Amplitudes and latencies of ACC

Time frame: one year at least after CI activation

amplitudes and latencies of P1/N1/P2 complex and Mismatch Negativity MMN

Time frame: one year at least after CI activation

Evolution of amplitude of auditory steady state responses ASSR

Evolution of ASSR amplitudes as a function of time during the first year of CI activation in newly implanted patients

Time frame: 1 month, 3 months, 6 months, 9 months and 12 months after CI activation

Evolution of spectro-temporal analysis of speech-ABR

Evolution of spectro-temporal analysis of speech-ABR as a function of time during the first year of CI activation in newly implanted patients

Time frame: 1 month, 3 months, 6 months, 9 months and 12 months after CI activation

Acoustic Change Complex ACC

Evolution of amplitudes and latencies of ACC as a function of time during the first year of CI activation in newly implanted patients

Time frame: 1 month, 3 months, 6 months, 9 months and 12 months after CI activation

amplitudes and latencies of P1/N1/P2 complex and Mismatch Negativity MMN

Evolution of amplitudes and latencies of P1N1P2 and MMN as a function of time during the first year of CI activation in newly implanted patients

Data from ClinicalTrials.gov

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