Cochlear ImplantEVODA-ICMNNCT03025386
Establish a Concordance Between the Mismatch Negativity Amplitude and a Score of Logatoms Discrimination
A study testing logatoms test and Electroencephalography in people with Cochlear Implant, run by University Hospital, Montpellier at 1 site in France.
Trial summary
A cochlear implant is a device for the rehabilitation of severe to profound hearing loss. Despite the standardization of surgical procedures and rehabilitation, speech discrimination performance varied significantly in cochlear implant users and could be improved by early individualized cares. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cochlear Implant
- What is being tested?
- logatoms test and Electroencephalography
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 18 May 2017to 2 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged from 18 to 75
- Severe to profound deafness
- Cochlear implant user for over a year
- Affiliation or beneficiary of the social insurance
Who cannot join
- Phonetically balanced kindergarten score less than 25%
- No steady setting
- Contralateral hearing aid
- Electroacoustic stimulation device or bilateral cochlear implant user
- Inactive electrodes > 3
- Cochlear Implant wore less than 7 hours per day
Show all 14Show fewer
- Disorders of memory, attention or executive functions
- Associated disorders with deafness
- No informed consent
- Patient participating in other biomedical research
- Patient who has undergone cochlear reimplantation or brain surgery
- Withdrawal of consents
- Patient lost to follow-up
- Death
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Establish a Concordance Between the Mismatch Negativity Amplitude and a Score of Logatoms Discrimination, Both Highlighting Capacities of Auditory Discrimination, in Adult Cochlear Implant Users
A cochlear implant is a device for the rehabilitation of severe to profound hearing loss. Despite the standardization of surgical procedures and rehabilitation, speech discrimination performance varied significantly in cochlear implant users and could be improved by early individualized cares. However, there is no objective method yet to evaluate phonemes discrimination, especially in infants, which account for more than half of the indications for implantation. In electroencephalography (EEG), it is possible to highlight the discrimination of auditory stimuli studying the wave of MisMatch Negativity (MMN). In this work, this study propose to use the MMN as an objective vocal audiometry method to evaluate the ability to discriminate phonemes, the smallest units of oral language, in adult cochlear implant users.
Read the detailed description
Context of the study Cochlear implant is an effective and recognized long-term solution for people with severe to profound neurosensory hearing loss. Its principle is to collect sounds of the environment, to analyze them, to transform them and, using an electrodes array placed in the cochlea, to transmit them back to the auditory nerve by electrical impulses. With practice, these are integrated and then recognized by the brain that associates a meaning. For normal hearing persons, speech recognition involves several time and frequency cues that the ear is able to decode. However, the cochlear implant distorts and alters some of these speech cues; the implant easily retransmits the temporal features but the frequency ones are much deteriorated. Thus, cochlear implant users preferentially use the temporal cues, which provide truncated and incomplete information, which often results in a lower quality understanding. Thus, learning or re-learning the language through the cochlear implant is difficult for the young deaf child as for the deaf adults.
The cochlear implant setting is essentially based on perceptual features. A detection threshold and a comfort level are fitting according to the perceptions of the patient and several objective tools. These provide important information but do not on the validity of the setting to ensure optimal speech understanding. The High Authority of Health suggests speech therapy in the overall rehabilitation of cochlear implant users. This aims to develop auditory skills according to four major perceptual axes: detection, identification, discrimination and understanding of sounds.
Despite these cares, cochlear implant users have speech recognition scores lower than those of normal-hearing people and have heterogeneous performances. Deafness etiology (auditory neuropathy, demyelization, ...), integrity of the auditory nerve, position of the electrode array in the cochlea, cognitive abilities, age implantation, duration of hearing loss, quality of cortical integration, cerebral plasticity, speech therapy, the family environment, implant fitting could affect subject performances.
Difficulties in speech understanding may be related to poor discrimination of phonemes, the smallest units of oral language. These phonemic confusions can be tested in adults by several tests such as the Phonetically Balanced Kindergarten test (PBK). However, in the very young child, childs with polyhandicap or the disabled adult, the evaluation of the language is more delicate and needs a long term.
Several electrophysiological techniques would nevertheless make it possible to objectively demonstrate the ability to discriminate phonemes in one measure. For example, the mismatch negativity wave (MMN) reflects a cognitive process showing the discrimination of two different sounds by the auditory system. It is measurable in adults and children, automatically and regardless of the level of vigilance. In this study use a MMN protocol to highlight phonemic discrimination capacities and then link them to subjective performances in the adult cochlear implant users. The first objective is to establish in these users a concordance between the amplitude of the MMN and a test of discrimination of logatoms, both highlighting the capacities of auditory discrimination. The second is to establish a concordance between the amplitude of the MMN and the scores obtained with the PBK.
Method
A forced choice test will evaluate the discrimination of the most confusing logatoms in the cochlear implant users, and representative of the French language. The following couples were selected:
- " fa " vs " sa "
- " la " vs " na "
- " pan " vs " pa "
- " pa " vs " ta "
- " pon " vs " po " Each couple of logatoms will be tested twenty times. If the score is greater than 16/20, the discrimination of logatoms pair will be considered positive. The test, carried out using Matlab MathWorks software, was automated so that the patient could do it without the intervention of the experimenter; It remains under its supervision in order to verify that the test is proceeding normally.
Obtaining the MMN requires a paradigm called "oddball", during which a "frequent" stimulus is emitted 80% of the time and a second stimulus called "deviant" is presented only 20% of the time. The high repetition rate of the frequent stimulus ("pa" for example) creates an electrophysiological baseline. When a deviant stimulus ("ba" for example) appears, this introduces a break in the electrophysiological baseline which results in the appearance of a so-called mismatch negative wave, the MMN. It shows the discrimination by the auditory system of two different stimuli. By studying the amplitude of this wave, it is possible to evaluate the quality of discrimination. A low or zero amplitude means that the subject did not discriminate the two logatoms. Conversely, the higher the amplitude, the greater the discrimination quality is. The wave latency can also be a variable to be observed. The earlier it is, the more it marks the ease of discrimination.
For each subject, the concordance with the score in the logatoms discrimination test will be analyzed separately for each pair. This will make it possible to evaluate the consistency of this concordance according to the pairs of tested logatoms. The optimal threshold of the MMN amplitude to identify subjects with good auditory discrimination is not yet known (innovative method). The first stage of our analysis will be to search for this threshold by constructing an receiver operating characteristic (ROC) curve to best distinguish patients with good and bad auditory discrimination in the test of the logatoms (choice of the threshold by the index of Youden). This threshold will then be used to classify subjects as having good or poor auditory discrimination according to the EEG. The agreement between the results of the EEG and the test of logatoms discrimination will then be analyzed by the calculation of a Kappa coefficient.
The PBK test will be used to evaluate an overall comprehension score. This test consists of 4 lists of 50 words respecting the occurrence of the phonemes of the French language and using mono- and bi-syllabic words. A score above 70% is accepted as a good performance. The concordance between the results of the EEG procedure for each logatoms (good and bad auditory discrimination defined as above) and the result of the PBK test will be analyzed using Kappa coefficients.
Finally, different secondary data will be collected: type of cochlear implant (mark, internal and external part), duration of implantation in months, etiology, data related to the implant setting (number of active electrodes , Thresholds C and T, IDR, automatic functions like SCAN, ADRO, ...)
- Conditions
- Cochlear Implant
- Being tested
- logatoms test, Electroencephalography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
logatoms testOther
A forced choice test will evaluate the discrimination of the most confusing logatoms in the cochlear implant users, and representative of the French language.
ElectroencephalographyOther
Mesure of the mismatch negativity wave
| Study group | Role | What they receive |
|---|---|---|
| Adult cochlear implant users | Other | Evaluation of a concordance between the mismatch negativity amplitude mesured by electroencephalography and the capacity of logatoms discrimination by using a logatoms test Receives: Other: logatoms test; Other: Electroencephalography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between MMN amplitude and logatoms discrimination score in the discrimination capacity
The discrimination capacity (positive/ negative) defined by an MMN amplitude above a threshold will be estimated using a ROC curve based on the logatoms discrimination scores The discrimination capacity defined by logatoms test will be positive if the discrimination score is higher or equal to 80%.
Measured: 30 days
Secondary outcomes (1)
Correlation between MMN amplitude and the Phonetically Balanced Kindergarten score and Vocoder test
The discrimination capacity will be positive if the correlation score is higher or equal to 70%.
Measured: within the first 30 days after the first visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2017 (estimated)
- Study start18 May 2017
- Primary completion2 Jun 2022
- Study completion2 Jun 2022
Why it stopped: inclusions stopped
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cochlear ImplantStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Frédéric VENAIL, PH, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03025386
- Sponsor's protocol ID
- RECHMPL16_0196
- Acronym
- EVODA-ICMN
- Status last verified
- Jan 2023
- First submitted
- 16 Jan 2017
- Last updated
- 30 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establish a Concordance Between the Mismatch Negativity Amplitude and a Score of Logatoms Discrimination, Both Highlighting Capacities of Auditory Discrimination, in Adult Cochlear Implant Users
- ClinicalTrials.gov ID
- NCT03025386
- Acronym / sponsor ID
- EVODA-ICMN / RECHMPL16_0196
- Conditions
- Cochlear Implant
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: inclusions stopped
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 18 May 2017 (actual)
- Primary completion
- 2 Jun 2022 (actual)
- Study completion
- 2 Jun 2022 (actual)
- First posted
- 19 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A cochlear implant is a device for the rehabilitation of severe to profound hearing loss. Despite the standardization of surgical procedures and rehabilitation, speech discrimination performance varied significantly in cochlear implant users and could be improved by early individualized cares. However, there is no objective method yet to evaluate phonemes discrimination, especially in infants, which account for more than half of the indications for implantation. In electroencephalography (EEG), it is possible to highlight the discrimination of auditory stimuli studying the wave of MisMatch Negativity (MMN). In this work, this study propose to use the MMN as an objective vocal audiometry method to evaluate the ability to discriminate phonemes, the smallest units of oral language, in adult cochlear implant users.
Detailed description
Context of the study Cochlear implant is an effective and recognized long-term solution for people with severe to profound neurosensory hearing loss. Its principle is to collect sounds of the environment, to analyze them, to transform them and, using an electrodes array placed in the cochlea, to transmit them back to the auditory nerve by electrical impulses. With practice, these are integrated and then recognized by the brain that associates a meaning. For normal hearing persons, speech recognition involves several time and frequency cues that the ear is able to decode. However, the cochlear implant distorts and alters some of these speech cues; the implant easily retransmits the temporal features but the frequency ones are much deteriorated. Thus, cochlear implant users preferentially use the temporal cues, which provide truncated and incomplete information, which often results in a lower quality understanding. Thus, learning or re-learning the language through the cochlear implant is difficult for the young deaf child as for the deaf adults.
The cochlear implant setting is essentially based on perceptual features. A detection threshold and a comfort level are fitting according to the perceptions of the patient and several objective tools. These provide important information but do not on the validity of the setting to ensure optimal speech understanding. The High Authority of Health suggests speech therapy in the overall rehabilitation of cochlear implant users. This aims to develop auditory skills according to four major perceptual axes: detection, identification, discrimination and understanding of sounds.
Despite these cares, cochlear implant users have speech recognition scores lower than those of normal-hearing people and have heterogeneous performances. Deafness etiology (auditory neuropathy, demyelization, ...), integrity of the auditory nerve, position of the electrode array in the cochlea, cognitive abilities, age implantation, duration of hearing loss, quality of cortical integration, cerebral plasticity, speech therapy, the family environment, implant fitting could affect subject performances.
Difficulties in speech understanding may be related to poor discrimination of phonemes, the smallest units of oral language. These phonemic confusions can be tested in adults by several tests such as the Phonetically Balanced Kindergarten test (PBK). However, in the very young child, childs with polyhandicap or the disabled adult, the evaluation of the language is more delicate and needs a long term.
Several electrophysiological techniques would nevertheless make it possible to objectively demonstrate the ability to discriminate phonemes in one measure. For example, the mismatch negativity wave (MMN) reflects a cognitive process showing the discrimination of two different sounds by the auditory system. It is measurable in adults and children, automatically and regardless of the level of vigilance. In this study use a MMN protocol to highlight phonemic discrimination capacities and then link them to subjective performances in the adult cochlear implant users. The first objective is to establish in these users a concordance between the amplitude of the MMN and a test of discrimination of logatoms, both highlighting the capacities of auditory discrimination. The second is to establish a concordance between the amplitude of the MMN and the scores obtained with the PBK.
Method
A forced choice test will evaluate the discrimination of the most confusing logatoms in the cochlear implant users, and representative of the French language. The following couples were selected:
- " fa " vs " sa "
- " la " vs " na "
- " pan " vs " pa "
- " pa " vs " ta "
- " pon " vs " po " Each couple of logatoms will be tested twenty times. If the score is greater than 16/20, the discrimination of logatoms pair will be considered positive. The test, carried out using Matlab MathWorks software, was automated so that the patient could do it without the intervention of the experimenter; It remains under its supervision in order to verify that the test is proceeding normally.
Obtaining the MMN requires a paradigm called "oddball", during which a "frequent" stimulus is emitted 80% of the time and a second stimulus called "deviant" is presented only 20% of the time. The high repetition rate of the frequent stimulus ("pa" for example) creates an electrophysiological baseline. When a deviant stimulus ("ba" for example) appears, this introduces a break in the electrophysiological baseline which results in the appearance of a so-called mismatch negative wave, the MMN. It shows the discrimination by the auditory system of two different stimuli. By studying the amplitude of this wave, it is possible to evaluate the quality of discrimination. A low or zero amplitude means that the subject did not discriminate the two logatoms. Conversely, the higher the amplitude, the greater the discrimination quality is. The wave latency can also be a variable to be observed. The earlier it is, the more it marks the ease of discrimination.
For each subject, the concordance with the score in the logatoms discrimination test will be analyzed separately for each pair. This will make it possible to evaluate the consistency of this concordance according to the pairs of tested logatoms. The optimal threshold of the MMN amplitude to identify subjects with good auditory discrimination is not yet known (innovative method). The first stage of our analysis will be to search for this threshold by constructing an receiver operating characteristic (ROC) curve to best distinguish patients with good and bad auditory discrimination in the test of the logatoms (choice of the threshold by the index of Youden). This threshold will then be used to classify subjects as having good or poor auditory discrimination according to the EEG. The agreement between the results of the EEG and the test of logatoms discrimination will then be analyzed by the calculation of a Kappa coefficient.
The PBK test will be used to evaluate an overall comprehension score. This test consists of 4 lists of 50 words respecting the occurrence of the phonemes of the French language and using mono- and bi-syllabic words. A score above 70% is accepted as a good performance. The concordance between the results of the EEG procedure for each logatoms (good and bad auditory discrimination defined as above) and the result of the PBK test will be analyzed using Kappa coefficients.
Finally, different secondary data will be collected: type of cochlear implant (mark, internal and external part), duration of implantation in months, etiology, data related to the implant setting (number of active electrodes , Thresholds C and T, IDR, automatic functions like SCAN, ADRO, ...)
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult cochlear implant users | Other | Other: logatoms test, Other: ElectroencephalographyEvaluation of a concordance between the mismatch negativity amplitude mesured by electroencephalography and the capacity of logatoms discrimination by using a logatoms test |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged from 18 to 75
- Severe to profound deafness
- Cochlear implant user for over a year
- Affiliation or beneficiary of the social insurance
Key exclusion criteria (14 listed)
- Phonetically balanced kindergarten score less than 25%
- No steady setting
- Contralateral hearing aid
- Electroacoustic stimulation device or bilateral cochlear implant user
- Inactive electrodes > 3
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| logatoms testA forced choice test will evaluate the discrimination of the most confusing logatoms in the cochlear implant users, and representative of the French language. | Other | Adult cochlear implant users |
| ElectroencephalographyMesure of the mismatch negativity wave | Other | Adult cochlear implant users |
Primary outcome
Correlation between MMN amplitude and logatoms discrimination score in the discrimination capacity
Time frame: 30 days
The discrimination capacity (positive/ negative) defined by an MMN amplitude above a threshold will be estimated using a ROC curve based on the logatoms discrimination scores The discrimination capacity defined by logatoms test will be positive if the discrimination score is higher or equal to 80%.
1 secondary outcome
Correlation between MMN amplitude and the Phonetically Balanced Kindergarten score and Vocoder test
Time frame: within the first 30 days after the first visit
Results and safety
The study was stopped early (reason given: inclusions stopped). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frédéric VENAIL, PH principal investigator
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing logatoms test and Electroencephalography in people with Cochlear Implant, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 30 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: inclusions stopped). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between MMN amplitude and logatoms discrimination score in the discrimination capacity (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2025.