Cochlear Hearing LossNCT04161261
Minimizing Facial Nerve Stimulation in Cochlear Implants
A study testing Electrical Stimulation in people with Cochlear Hearing Loss and Hearing Loss, Sensorineural, run by Cambridge University Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
This study aims to understand how to manipulate the electrical stimulation from the cochlear implant to maximize hearing stimulation and minimize facial stimulation. It is know from animal data that the hearing and facial nerves have different sensitivities to things like electrical pulse shape, its pattern, and its… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cochlear Hearing Loss, Hearing Loss, Sensorineural, Hearing Loss
- What is being tested?
- Electrical Stimulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 13 Dec 2019to 1 Nov 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participant is willing and able to give informed consent for participation in the study.
- Male or Female, aged 18 years or above.
- Unilateral user of a cochlear implant or at least 6 months (post-operative group), or prospective CI user, meeting NICE criteria for implantation (intra-operative group).
- First language English or sufficiently fluent in English to understand the consenting process
- Post-lingual onset of severe to profound hearing loss
- No other handicaps that would interfere with participation in the study in the opinion of the Principal Investigator
Who cannot join
- Unstable cochlear implant or hearing aid fitting
- Using medication in an intermittent manner that might influence hearing levels
- Cognitive or psychological challenges that might lead to variations in attention
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to understand how to manipulate the electrical stimulation from the cochlear implant to maximize hearing stimulation and minimize facial stimulation. It is know from animal data that the hearing and facial nerves have different sensitivities to things like electrical pulse shape, its pattern, and its duration. It is very unclear however if this applies to human cochlear implant patients, and what the optimal parameters are to selectively stimulate the hearing nerve in humans. The outcomes of this study will be used to more selectively program some patients with severe facial nerve cross stimulation and to inform the development of new types of implant stimulation.
Read the detailed description
The patients eligible for the study are deaf, and have consented as part of their standard of care to receiving a cochlear implant. There will be no interference with this process in any way. Those patients that are unfortunate to be affected by facial nerve stimulation following receiving their cochlear implant however will be contacted and with the aim to help improve their symptoms as indicated in prior animal studies
- Conditions
- Cochlear Hearing Loss, Hearing Loss, Sensorineural, Hearing Loss, Facial Nerve Injury, Nerve Disorders
- Being tested
- Electrical Stimulation
- Medical subject headings
- Hearing Loss, Sensorineural, Hearing Loss, Facial Nerve Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electrical StimulationProcedure or surgery
To measure the facial nerve stimulation threshold for one mid-array and one apical electrode of the implant using the pulse-train stimuli
| Study group | Role | What they receive |
|---|---|---|
| IntraOperative Group | Experimental | The intra-operative group consists of patients who have met criteria for cochlear implants. We monitor the facial nerve EMG intraoperatively in all patients, and often get some facial nerve activation when we are testing the implant intraoperatively when we are looking to see if we are getting any hearing nerve responses from electrical stimulation of the implant. We will also measure the facial nerve responses for some other charge-balanced pulse shapes, which are asymmetric and in which either the positive or negative charge is expected to stimulate the nerve. We will only measure these for two electrodes, not for all 12-22 electrodes They will be then invited back post operatively for a second testing during a standard of care visit post switch on for other pulse shapes. Receives: Procedure: Electrical Stimulation |
| PostOperative Group | Experimental | The post-operative group, are patients who are actually having facial nerve stimulation on one or more electrodes, and for whom these electrodes are turned down so much they can't hear very well, or are actually turned off because of the facial nerve stimulation. For these patients, we will slowly increase the current levels on the offending electrodes (maximum of two) until they get some facial nerve twitching, and then turn down the current until they do not have stimulation any more. We will do this for all pulse shapes and determine which shape produces the greatest loudness without stimulating the facial nerve. This will be the only testing session for the second group. Receives: Procedure: Electrical Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
To identify stimulus parameters for cochlear implant stimulation that achieve sufficient loudness for hearing, while minimizing stimulation of the facial nerve.
The loudness level, or auditory nerve response at which facial nerve stimulation occurs for different stimulation pulse shapes will be measured for all 24 patients on both groups and help to identify different optimal stimulus parameters.
By comparing the amount of electrical current required to initiate a facial nerve response for each pulse shape this will determine if there is an optimal type of stimulation to use, to reduce facial nerve stimulation.
Measured: 18 months
Secondary outcomes (1)
To increase scientific understanding of the biology of the auditory and facial nerve's responses to stimulation.
This is a hugely under researched field where we are pioneering techniques and so exact outcome measures may be difficult to quantify in this scientific investigation.
We are not able to use questionnaires or scientific tools at this stage, however this can be measured through electrical current measurements on the volta software for the Advanced Bionics cochlear implant company.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2019
- Study start13 Dec 2019
- Primary completion3 May 2022 (estimated)
- Study completion1 Nov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cochlear 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- We will have 2 groups of patients. An Intraoperative group (undergoing cochlear implantation) and a post operative group (with pre existing facial nerve stimulation). The study compares the effectiveness of different pulse shapes within each group, rather than performing a between-group comparison
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cambridge University Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- University of Cambridge, Medical Research Council Cognition and Brain Sciences Unit
- Responsible party
- Principal investigator, Sophie McKenny, Cambridge University Hospitals NHS Foundation Trust
- Investigators
- Manohar L Bance, Professor, Principal investigator, Cambridge University Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04161261
- Sponsor's protocol ID
- 272538
- Status last verified
- Jul 2021
- First submitted
- 5 Nov 2019
- Last updated
- 29 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Upon completion of study, data will be disseminated into research community anonymised. IPD will not be accessible to researchers outside the clinical care team.
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Minimizing Facial Nerve Stimulation in Cochlear Implants
- ClinicalTrials.gov ID
- NCT04161261
- Acronym / sponsor ID
- 272538
- Conditions
- Cochlear Hearing Loss, Hearing Loss, Sensorineural, Hearing Loss, Facial Nerve Injury, Nerve Disorders
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Cambridge University Hospitals NHS Foundation TrustUniversity, hospital or other
- Collaborators
- University of Cambridge, Medical Research Council Cognition and Brain Sciences Unit
- Study start
- 13 Dec 2019 (actual)
- Primary completion
- 3 May 2022 (estimated)
- Study completion
- 1 Nov 2022 (estimated)
- First posted
- 13 Nov 2019 (actual)
- 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.
This study aims to understand how to manipulate the electrical stimulation from the cochlear implant to maximize hearing stimulation and minimize facial stimulation. It is know from animal data that the hearing and facial nerves have different sensitivities to things like electrical pulse shape, its pattern, and its duration. It is very unclear however if this applies to human cochlear implant patients, and what the optimal parameters are to selectively stimulate the hearing nerve in humans. The outcomes of this study will be used to more selectively program some patients with severe facial nerve cross stimulation and to inform the development of new types of implant stimulation.
Detailed description
The patients eligible for the study are deaf, and have consented as part of their standard of care to receiving a cochlear implant. There will be no interference with this process in any way. Those patients that are unfortunate to be affected by facial nerve stimulation following receiving their cochlear implant however will be contacted and with the aim to help improve their symptoms as indicated in prior animal studies
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- We will have 2 groups of patients. An Intraoperative group (undergoing cochlear implantation) and a post operative group (with pre existing facial nerve stimulation). The study compares the effectiveness of different pulse shapes within each group, rather than performing a between-group comparison
| Arm | Type | Receives |
|---|---|---|
| IntraOperative Group | Experimental | Procedure: Electrical StimulationThe intra-operative group consists of patients who have met criteria for cochlear implants. We monitor the facial nerve EMG intraoperatively in all patients, and often get some facial nerve activation when we are testing the implant intraoperatively when we are looking to see if we are getting any hearing nerve responses from electrical stimulation of the implant. We will also measure the facial nerve responses for some other charge-balanced pulse shapes, which are asymmetric and in which either the positive or negative charge is expected to stimulate the nerve. We will only measure these for two electrodes, not for all 12-22 electrodes They will be then invited back post operatively for a second testing during a standard of care visit post switch on for other pulse shapes. |
| PostOperative Group | Experimental | Procedure: Electrical StimulationThe post-operative group, are patients who are actually having facial nerve stimulation on one or more electrodes, and for whom these electrodes are turned down so much they can't hear very well, or are actually turned off because of the facial nerve stimulation. For these patients, we will slowly increase the current levels on the offending electrodes (maximum of two) until they get some facial nerve twitching, and then turn down the current until they do not have stimulation any more. We will do this for all pulse shapes and determine which shape produces the greatest loudness without stimulating the facial nerve. This will be the only testing session for the second group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Participant is willing and able to give informed consent for participation in the study.
Key exclusion criteria (3 listed)
- Unstable cochlear implant or hearing aid fitting
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 |
|---|---|---|
| Electrical StimulationTo measure the facial nerve stimulation threshold for one mid-array and one apical electrode of the implant using the pulse-train stimuli | Procedure or surgery | IntraOperative Group, PostOperative Group |
Primary outcome
To identify stimulus parameters for cochlear implant stimulation that achieve sufficient loudness for hearing, while minimizing stimulation of the facial nerve.
Time frame: 18 months
The loudness level, or auditory nerve response at which facial nerve stimulation occurs for different stimulation pulse shapes will be measured for all 24 patients on both groups and help to identify different optimal stimulus parameters. By comparing the amount of electrical current required to initiate a facial nerve response for each pulse shape this will determine if there is an optimal type of stimulation to use, to reduce facial nerve stimulation.
1 secondary outcome
To increase scientific understanding of the biology of the auditory and facial nerve's responses to stimulation.
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2021.
- Individual participant dataSharing planned: No. Upon completion of study, data will be disseminated into research community anonymised. IPD will not be accessible to researchers outside the clinical care team.
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Hearing Loss
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.
Manohar L Bance, Professor principal investigator
Cambridge University Hospitals 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 Electrical Stimulation in people with Cochlear Hearing Loss and Hearing Loss, Sensorineural, run by Cambridge University Hospitals 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 6 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 29 Jul 2021. 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?
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?
To identify stimulus parameters for cochlear implant stimulation that achieve sufficient loudness for hearing, while minimizing stimulation of the facial nerve. (time frame: 18 months). 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 29 Jul 2021.