ClinicalTrials.gg
Enrolling by invitationNCT04161261Updated Nov 12, 2026

Minimizing Facial Nerve Stimulation in Cochlear Implants

An interventional study of Electrical Stimulation in Cochlear Hearing Loss, Hearing Loss, Sensorineural and Hearing Loss, sponsored by Cambridge University Hospitals NHS Foundation Trust. Enrolling by invitation at 1 site in United Kingdom. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-12.

Sponsored by Cambridge University Hospitals NHS Foundation Trust · Not applicable, Interventional, and Diagnostic

Updated Nov 12, 2026Now Enrolling by invitationPrimary completion moved+1 moreGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
24
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 22 studies in Hearing Loss, Sensorineural with a site in United Kingdom — 8 open to participants now, 8 under way, 1 of them phase 3. Hearing Loss, Sensorineural · United Kingdom.

Planned enrollment
8th of 11
24 · median 36
Started
2019
with 5 others
No phase
8 of 22
3 open now
Registered
8th of 22
by date
Lead sponsor
3 of 22
Cambridge University Hospitals NHS Foundation Trust

Among the 22 studies in Hearing Loss, Sensorineural with a site in United Kingdom, this one is the 8th largest by planned enrollment of the 11 interventional ones that give a count, is one of 6 that started in 2019, is one of 8 with no phase, and was the 8th registered.

Hearing Loss, Sensorineural

346 studies on the registry are indexed under Hearing Loss, Sensorineural; 101 are open to participants now.

Browse Hearing Loss, Sensorineural studies →

Open to participants now

8 of the 22 studies in Hearing Loss, Sensorineural with a site in United Kingdom are open now. Recruiting first, the newest first:

2 more — sign in →

All 8 open studies →

A study can be open while its sites in United Kingdom have not opened yet or have stopped. Only those recruiting at a site in United Kingdom →

Who these studies take

Of the 70 Hearing Loss, Sensorineural studies recruiting now, 39 (56%) set no upper age limit and 19 (27%) stop at 75 or younger; 26 take children under 18; 17 take healthy volunteers.

This study: 18 Years and older · all sexes · healthy volunteers too.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

Was this useful?
Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 22 studies in Hearing Loss, Sensorineural with a site in United Kingdom, or all of them as a file.
02

Study 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 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

03

Conditions studied

  • Cochlear Hearing Loss
  • Hearing Loss, Sensorineural
  • Hearing Loss
  • Facial Nerve Injury
  • Nerve Disorders
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Participant is willing and able to give 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

Exclusion criteria

Exclusion Criteria:

  • 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
24 participants (estimated)

Study arms

  • Experimental
    IntraOperative Group

    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.

    Procedure: Electrical Stimulation

  • Experimental
    PostOperative Group

    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.

    Procedure: Electrical Stimulation

Interventions

  • ProcedureElectrical Stimulation

    To measure the facial nerve stimulation threshold for one mid-array and one apical electrode of the implant using the pulse-train stimuli

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 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.

    Time frame: 18 months

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: 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.

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it movedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Dec 2019 (actual). Primary completion is estimated for May 2027, 88 months after the start.

Of 82 non-industry interventional studies with no phase under Hearing Loss, Sensorineural, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 83. This study's planned 88 months is above that.

Counting every sponsor, half of 162 studies reached it within 22 months; a quarter within 6 and three quarters within 44.

Since we started tracking on Sep 25, 2026, the dates moved once, on Nov 12, 2026: primary completion May 2022 → May 2027 and completion Nov 2022 → Nov 2028.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Nov 5, 2019
First posted
Nov 13, 2019
StartActual
Dec 13, 2019
Primary completionEst.
May 3, 2027was May 2022
CompletionEst.
Nov 1, 2028was Nov 2022
Last update
Nov 12, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Status unknown→Enrolling by invitation
changed Nov 12, 2026
Primary completion
May 3, 2022→May 3, 2027
Nov 12, 2026
Study completion
Nov 1, 2022→Nov 1, 2028
Nov 12, 2026
Show all 1 update
  1. Nov 12, 2026
    Status unknown→Enrolling by invitation
    Primary completion May 3, 2022→May 3, 2027
    Study completion Nov 1, 2022→Nov 1, 2028
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT04161261
Collaborators
University of Cambridge, Medical Research Council Cognition and Brain Sciences Unit
Responsible party
Sophie McKenny (/Chief Investigator Professor Manohar Bance, Cambridge University Hospitals NHS Foundation Trust) — Principal investigator
First posted
Nov 13, 2019
Start date
Dec 13, 2019
Primary completion
May 3, 2027 (estimated)
Completion
Nov 1, 2028 (estimated)
Last update
Nov 12, 2026

Study contacts

Manohar L Bance, Professor
principal investigator · Cambridge University Hospitals NHS Foundation Trust

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

No contact was published for this record. The registry link below has the sponsor’s details.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion