Hearing LossNCT02407587
Neuroplastic Changes Seen in Cochlear Implants With Preserved Hearing
A study testing cochlear implants in people with Hearing Loss, run by Manchester University NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Investigators hope to study patients with 1 cochlear implant and who have had hearing preservation surgery and compare the changes in the brain of these patients with normal hearing patients by doing a scan of the brain when listening to speech. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hearing Loss
- What is being tested?
- cochlear implants
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- May 2013to 27 Feb 2017
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Mature users of unilateral cochlear implants who have natural preserved hearing in the implanted ear
- Healthy volunteers with normal hearing
- Right handed
Who cannot join
- Individuals with neurological or psychiatric illness
- Patients involved in additional drug trials
- Pregnant or breast feeding women
- Children
- Left-handed subjects
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Central Manchester University Hospitals NHS Foundation Trust
Manchester, Manchester (Manchester Borough), M13 9WL
About this study
Official title: Cortical Activity in Subjects With Unilateral Cochlear Implants and Preserved Ipsilateral Residual Hearing and the Evolution of Temporal Cortex Changes in New Recipients of Cochlear Implants.
Investigators hope to study patients with 1 cochlear implant and who have had hearing preservation surgery and compare the changes in the brain of these patients with normal hearing patients by doing a scan of the brain when listening to speech. The information investigators collect may help investigators to understand how the brain learns to hear with a cochlear implant and whether it uses the same areas in the brain to listen as in normal hearing patients as well as predict which patients will do well with a cochlear implant as a very specialised operation is needed to insert the cochlear implant in to the ear and is done by very few surgeons in the country. After the operation, patients need several months of teaching to help them learn how to hear through the implant. Having a cochlear implant requires a lot of cooperation and time from the patient and if investigators could understand how the brain learns to hear with a cochlear implant and predict which patients do well and why then we may be able to avoid unnecessary procedures.
Read the detailed description
Cochlear implants are an established treatment for individuals with hearing loss where conventional hearing aids fail to provide appropriate hearing amplification and result in poor speech and language perception.
Although a large proportion of patients with cochlear implants are expected to do well with an implant, there is still uncertainty why some individuals do poorly.
Furthermore investigators have limited knowledge about how the brain interacts with a cochlear implant to process speech. Evidence suggests that the underlying central mechanisms responsible for processing speech using an implant are related to neuroplasticity. That is to say that the brain establishes new cortical networks between the vital auditory centres and the cochlear implant thus enabling processing of speech.
Investigators have recently completed a study comparing the cortical changes that occur in subjects with bilateral cochlear implants to normal hearing controls. In this study both groups of patients were subjected to binaural simultaneous auditory stimuli. Analysis suggests that subjects with bilateral cochlear implants and postlingual hearing loss seem to recruit similar areas of the temporal lobes to process speech as their normal hearing counterparts.
The implant recipients activations were larger and more diffuse but did not differ greatly from those described previously in normal hearing. This study provides a good comparison of hearing using bilateral cochlear implants to that of normal unaided hearing. This study provides a more realistic comparison of cortical activations due to hearing in cochlear implantees and normal hearing subjects. This is in contrast to other studies involving monaural stimulation of a unilateral cochlear implant to monaural stimulation of normal hearing subject with the contralateral normal hearing ear blocked off. Investigators are only aware of one additional study where subjects with bilateral cochlear implants have been compared to normal hearing controls.
In addition investigators did not observe any recruitment of the visual cortices in our bilaterally implanted subjects. This finding was also present in Strelnikov's study. However previous work has suggested subjects with cochlear implants rely on visual clues to process speech as a result of the degraded signal provided by the implant. It is possible that because the subjects in this study and Strelnikov's study were experienced implant users and benefited from binaural auditory stimulation, they were not dependant on audio-visual integration to process speech.
There has been an increasing trend towards hearing preservation surgery for patients undergoing cochlear implantation. Literature supports improved speech and pitch perception in quiet and noise for subjects who combine the use of their implant with any residual preserved natural hearing compared with using the implant alone. Once again the the underlying mechanisms for this are unknown. It would be of scientific interest to investigate the interaction between natural residual hearing and hearing via a cochlear implant. It is likely that this cohort of subjects process speech similarly to those with normal hearing.
Finally, studies have monitored the speech progression of implantees from before surgery to several years post implant switch on. It has been suggested that the predominant improvement in speech perception occurs in the first year of implant use. This would suggest that the neuronal networks responsible for speech processing are established very early on however, investigators are not aware of any studies which have attempted to track the evolution of the temporal cortices in new recipients of cochlear implants.
- Conditions
- Hearing Loss
- Being tested
- cochlear implants
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cochlear implantsDevice
PET scans for the mature patients with unilateral cochlear implants and preserved hearing
4 states and each state will be repeated 3 times Cochlear implant only Residual hearing only Combination of implant and residual hearing No auditory stimulation
| Study group | Role | What they receive |
|---|---|---|
| unilateral cochlear implants | Experimental | Study Group
PET scans for the mature patients with unilateral cochlear implants and preserved hearing
4 states and each state will be repeated 3 times Cochlear implant only Residual hearing only Combination of implant and residual hearing No auditory stimulation Receives: Device: cochlear implants |
| Healthy volunteers | No intervention | 4 states and each state will be repeated 3 times Auditory stimulation Left ear only Auditory stimulation right ear only Binaural auditory stimulation Silence |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increase our understanding of why outcomes following a cochlear implant are heterogenous. This information may be used to provide targeted rehabilitation for candidates performing poorly with their implants and minimise rejection of the implant.
We anticipate that the recruitment of patients, data collection and analysis would take a maximum of 4 months
Study Group
PET scans for the mature patients with unilateral cochlear implants and preserved hearing
4 states and each state will be repeated 3 times Cochlear implant only Residual hearing only Combination of implant and residual hearing No auditory stimulation
Control Group
4 states and each state will be repeated 3 times Auditory stimulation Left ear only Auditory stimulation right ear only Binaural auditory stimulation Silence
Measured: 1 year
Secondary outcomes (2)
Combine the data from both of our studies and future studies in order to conduct meta-analysis to investigate further how language is processed in patients with cochlear implants.
Measured: 1 year
Determine if functional neuroimaging modalities have a future role in the selection process for potential cochlear implant candidates and in predicting outcome for each individual.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2015 (estimated)
- Study startMay 2013 (estimated)
- Primary completionOct 2015 (estimated)
- Study completion27 Feb 2017
Why it stopped: unresolved issues with a collaborator.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing LossStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Manchester University NHS Foundation Trust
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Rohini Aggrawal, Principal investigator, Manchester University NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02407587
- Sponsor's protocol ID
- R01997
- Status last verified
- Jan 2019
- First submitted
- 18 Sep 2014
- Last updated
- 18 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cortical Activity in Subjects With Unilateral Cochlear Implants and Preserved Ipsilateral Residual Hearing and the Evolution of Temporal Cortex Changes in New Recipients of Cochlear Implants.
- ClinicalTrials.gov ID
- NCT02407587
- Acronym / sponsor ID
- R01997
- Conditions
- Hearing Loss
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: unresolved issues with a collaborator.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Manchester University NHS Foundation TrustOther government
- Study start
- May 2013 (estimated)
- Primary completion
- Oct 2015 (estimated)
- Study completion
- 27 Feb 2017 (actual)
- First posted
- 3 Apr 2015 (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.
Investigators hope to study patients with 1 cochlear implant and who have had hearing preservation surgery and compare the changes in the brain of these patients with normal hearing patients by doing a scan of the brain when listening to speech. The information investigators collect may help investigators to understand how the brain learns to hear with a cochlear implant and whether it uses the same areas in the brain to listen as in normal hearing patients as well as predict which patients will do well with a cochlear implant as a very specialised operation is needed to insert the cochlear implant in to the ear and is done by very few surgeons in the country. After the operation, patients need several months of teaching to help them learn how to hear through the implant. Having a cochlear implant requires a lot of cooperation and time from the patient and if investigators could understand how the brain learns to hear with a cochlear implant and predict which patients do well and why then we may be able to avoid unnecessary procedures.
Detailed description
Cochlear implants are an established treatment for individuals with hearing loss where conventional hearing aids fail to provide appropriate hearing amplification and result in poor speech and language perception.
Although a large proportion of patients with cochlear implants are expected to do well with an implant, there is still uncertainty why some individuals do poorly.
Furthermore investigators have limited knowledge about how the brain interacts with a cochlear implant to process speech. Evidence suggests that the underlying central mechanisms responsible for processing speech using an implant are related to neuroplasticity. That is to say that the brain establishes new cortical networks between the vital auditory centres and the cochlear implant thus enabling processing of speech.
Investigators have recently completed a study comparing the cortical changes that occur in subjects with bilateral cochlear implants to normal hearing controls. In this study both groups of patients were subjected to binaural simultaneous auditory stimuli. Analysis suggests that subjects with bilateral cochlear implants and postlingual hearing loss seem to recruit similar areas of the temporal lobes to process speech as their normal hearing counterparts.
The implant recipients activations were larger and more diffuse but did not differ greatly from those described previously in normal hearing. This study provides a good comparison of hearing using bilateral cochlear implants to that of normal unaided hearing. This study provides a more realistic comparison of cortical activations due to hearing in cochlear implantees and normal hearing subjects. This is in contrast to other studies involving monaural stimulation of a unilateral cochlear implant to monaural stimulation of normal hearing subject with the contralateral normal hearing ear blocked off. Investigators are only aware of one additional study where subjects with bilateral cochlear implants have been compared to normal hearing controls.
In addition investigators did not observe any recruitment of the visual cortices in our bilaterally implanted subjects. This finding was also present in Strelnikov's study. However previous work has suggested subjects with cochlear implants rely on visual clues to process speech as a result of the degraded signal provided by the implant. It is possible that because the subjects in this study and Strelnikov's study were experienced implant users and benefited from binaural auditory stimulation, they were not dependant on audio-visual integration to process speech.
There has been an increasing trend towards hearing preservation surgery for patients undergoing cochlear implantation. Literature supports improved speech and pitch perception in quiet and noise for subjects who combine the use of their implant with any residual preserved natural hearing compared with using the implant alone. Once again the the underlying mechanisms for this are unknown. It would be of scientific interest to investigate the interaction between natural residual hearing and hearing via a cochlear implant. It is likely that this cohort of subjects process speech similarly to those with normal hearing.
Finally, studies have monitored the speech progression of implantees from before surgery to several years post implant switch on. It has been suggested that the predominant improvement in speech perception occurs in the first year of implant use. This would suggest that the neuronal networks responsible for speech processing are established very early on however, investigators are not aware of any studies which have attempted to track the evolution of the temporal cortices in new recipients of cochlear implants.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| unilateral cochlear implants | Experimental | Device: cochlear implantsStudy Group PET scans for the mature patients with unilateral cochlear implants and preserved hearing 4 states and each state will be repeated 3 times Cochlear implant only Residual hearing only Combination of implant and residual hearing No auditory stimulation |
| Healthy volunteers | No intervention | –4 states and each state will be repeated 3 times Auditory stimulation Left ear only Auditory stimulation right ear only Binaural auditory stimulation Silence |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Mature users of unilateral cochlear implants who have natural preserved hearing in the implanted ear
- Healthy volunteers with normal hearing
- Right handed
Key exclusion criteria (5 listed)
- Individuals with neurological or psychiatric illness
- Patients involved in additional drug trials
- Pregnant or breast feeding women
- Children
- Left-handed subjects
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 |
|---|---|---|
| cochlear implantsPET scans for the mature patients with unilateral cochlear implants and preserved hearing 4 states and each state will be repeated 3 times Cochlear implant only Residual hearing only Combination of implant and residual hearing No auditory stimulation | Device | unilateral cochlear implants |
Primary outcome
Increase our understanding of why outcomes following a cochlear implant are heterogenous. This information may be used to provide targeted rehabilitation for candidates performing poorly with their implants and minimise rejection of the implant.
Time frame: 1 year
We anticipate that the recruitment of patients, data collection and analysis would take a maximum of 4 months Study Group PET scans for the mature patients with unilateral cochlear implants and preserved hearing 4 states and each state will be repeated 3 times Cochlear implant only Residual hearing only Combination of implant and residual hearing No auditory stimulation Control Group 4 states and each state will be repeated 3 times Auditory stimulation Left ear only Auditory stimulation right ear only Binaural auditory stimulation Silence
2 secondary outcomes
Combine the data from both of our studies and future studies in order to conduct meta-analysis to investigate further how language is processed in patients with cochlear implants.
Time frame: 1 year
Determine if functional neuroimaging modalities have a future role in the selection process for potential cochlear implant candidates and in predicting outcome for each individual.
Time frame: 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2019.
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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.
Rohini Aggrawal principal investigator
Manchester University NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cochlear implants in people with Hearing Loss, run by Manchester University NHS Foundation Trust at 1 site in United Kingdom.
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 3 inclusion and 5 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: withdrawn, as of the sponsor's last update on 18 Jan 2019. 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 United Kingdom. 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 withdrawn before enrolling participants, so there are no results.
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?
Increase our understanding of why outcomes following a cochlear implant are heterogenous. This information may be used to provide targeted rehabilitation for candidates performing poorly with their implants and minimise rejection of the implant. (time frame: 1 year). 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 18 Jan 2019.