Neurophysiological Measures of Auditory Perception and Rehabilitation in Cochlear Implanted Patients

NCT ID: NCT02323256

Last Updated: 2025-08-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

91 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-31

Study Completion Date

2018-05-31

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.

Detailed Description

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Conditions

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Deafness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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newly cochlear implanted adult patients

longitudinal group

Group Type EXPERIMENTAL

Auditory steady-state response ASSR

Intervention Type OTHER

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

Speech-ABR

Intervention Type OTHER

Acoustic Change Complex ACC

Intervention Type OTHER

comparison of ACC complex in response to changes within speech stimulation

P1-N1-P2 complex and Mismatch Negativity MMN

Intervention Type OTHER

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

newly cochlear implanted children

longitudinal group

Group Type EXPERIMENTAL

Auditory steady-state response ASSR

Intervention Type OTHER

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

Speech-ABR

Intervention Type OTHER

Acoustic Change Complex ACC

Intervention Type OTHER

comparison of ACC complex in response to changes within speech stimulation

P1-N1-P2 complex and Mismatch Negativity MMN

Intervention Type OTHER

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

cochlear implanted adult patients (CI>1 year)

transversal group

Group Type ACTIVE_COMPARATOR

Auditory steady-state response ASSR

Intervention Type OTHER

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

Speech-ABR

Intervention Type OTHER

Acoustic Change Complex ACC

Intervention Type OTHER

comparison of ACC complex in response to changes within speech stimulation

P1-N1-P2 complex and Mismatch Negativity MMN

Intervention Type OTHER

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

normal hearing adult subjects

transversal group

Group Type ACTIVE_COMPARATOR

Auditory steady-state response ASSR

Intervention Type OTHER

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

Speech-ABR

Intervention Type OTHER

Acoustic Change Complex ACC

Intervention Type OTHER

comparison of ACC complex in response to changes within speech stimulation

P1-N1-P2 complex and Mismatch Negativity MMN

Intervention Type OTHER

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

Interventions

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Auditory steady-state response ASSR

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

Intervention Type OTHER

Speech-ABR

Intervention Type OTHER

Acoustic Change Complex ACC

comparison of ACC complex in response to changes within speech stimulation

Intervention Type OTHER

P1-N1-P2 complex and Mismatch Negativity MMN

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

Intervention Type OTHER

Other Intervention Names

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comparison of spectro-temporal analysis of speech-ABR generated in response to speech syllables

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
Minimum Eligible Age

1 Year

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hospices Civils de Lyon - Hopital Edouard Herriot

Lyon, , France

Site Status

Countries

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France

References

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Attina V, Mina F, Stahl P, Duroc Y, Veuillet E, Truy E, Thai-Van H. A New Method to Test the Efficiency of Cochlear Implant Artifacts Removal From Auditory Evoked Potentials. IEEE Trans Neural Syst Rehabil Eng. 2017 Dec;25(12):2453-2460. doi: 10.1109/TNSRE.2017.2723952. Epub 2017 Jul 6.

Reference Type RESULT
PMID: 28692981 (View on PubMed)

Other Identifiers

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2014-A00345-42

Identifier Type: OTHER

Identifier Source: secondary_id

2014.857

Identifier Type: -

Identifier Source: org_study_id

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