Neurophysiological Measures of Auditory Perception and Rehabilitation in Cochlear Implanted Patients

Study Overview
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Brief Summary
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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.

Official Title
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Neurophysiological Measures During Sound and Speech Perception in Cochlear Implanted Patients and Development of New Speech Rehabilitation Tools

Conditions
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Deafness

Intervention / Treatment
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* Other: Auditory steady-state response ASSR
* Other: Speech-ABR
* Other: Acoustic Change Complex ACC
* Other: P1-N1-P2 complex and Mismatch Negativity MMN


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: newly cochlear implanted adult patients<br>longitudinal group | Other: Auditory steady-state response ASSR<br>* comparison of ASSR amplitudes in response to amplitude-modulated sounds delivered at different intensities<br>Other: Speech-ABR<br> <br> * Other names: comparison of spectro-temporal analysis of speech-ABR generated in response to speech syllables;Other: Acoustic Change Complex ACC<br>* comparison of ACC complex in response to changes within speech stimulation<br>Other: P1-N1-P2 complex and Mismatch Negativity MMN<br>* comparison of amplitudes and latencies of P1-N1-P2 complex and MMN generated in response to the detection of changes in a series of auditory stimulation<br>|
| Experimental: newly cochlear implanted children<br>longitudinal group | Other: Auditory steady-state response ASSR<br>* comparison of ASSR amplitudes in response to amplitude-modulated sounds delivered at different intensities<br>Other: Speech-ABR<br> <br> * Other names: comparison of spectro-temporal analysis of speech-ABR generated in response to speech syllables;Other: Acoustic Change Complex ACC<br>* comparison of ACC complex in response to changes within speech stimulation<br>Other: P1-N1-P2 complex and Mismatch Negativity MMN<br>* comparison of amplitudes and latencies of P1-N1-P2 complex and MMN generated in response to the detection of changes in a series of auditory stimulation<br>|
| Active Comparator: cochlear implanted adult patients (CI>1 year)<br>transversal group | Other: Auditory steady-state response ASSR<br>* comparison of ASSR amplitudes in response to amplitude-modulated sounds delivered at different intensities<br>Other: Speech-ABR<br> <br> * Other names: comparison of spectro-temporal analysis of speech-ABR generated in response to speech syllables;Other: Acoustic Change Complex ACC<br>* comparison of ACC complex in response to changes within speech stimulation<br>Other: P1-N1-P2 complex and Mismatch Negativity MMN<br>* comparison of amplitudes and latencies of P1-N1-P2 complex and MMN generated in response to the detection of changes in a series of auditory stimulation<br>|
| Active Comparator: normal hearing adult subjects<br>transversal group | Other: Auditory steady-state response ASSR<br>* comparison of ASSR amplitudes in response to amplitude-modulated sounds delivered at different intensities<br>Other: Speech-ABR<br> <br> * Other names: comparison of spectro-temporal analysis of speech-ABR generated in response to speech syllables;Other: Acoustic Change Complex ACC<br>* comparison of ACC complex in response to changes within speech stimulation<br>Other: P1-N1-P2 complex and Mismatch Negativity MMN<br>* comparison of amplitudes and latencies of P1-N1-P2 complex and MMN generated in response to the detection of changes in a series of auditory stimulation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amplitude of auditory steady state responses ASSR |  | one year at least after CI activation | 
| Spectro-temporal analysis of speech-ABR |  | one year at least after CI activation | 
| Acoustic Change Complex ACC | Amplitudes and latencies of ACC | one year at least after CI activation | 
| amplitudes and latencies of P1/N1/P2 complex and Mismatch Negativity MMN |  | 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 | 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 | 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 | 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 | 1 month, 3 months, 6 months, 9 months and 12 months after CI activation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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deafness, cochlear implant, audiometry, speech perception, severe to profound deafness restored with cochlear implantation