Back to resultsMinimizing Facial Nerve Stimulation in Cochlear Implants
Primary Purpose
Cochlear Hearing Loss, Hearing Loss, Sensorineural, Hearing Loss
Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Electrical Stimulation
Sponsored by
About this trial
This is an interventional diagnostic trial for Cochlear Hearing Loss
Eligibility Criteria
Inclusion Criteria:
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
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
Sites / Locations
- Addenbrookes Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
IntraOperative Group
PostOperative Group
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT04161261
First Posted
November 5, 2019
Last Updated
July 28, 2021
Sponsor
Cambridge University Hospitals NHS Foundation Trust
Collaborators
University of Cambridge, Medical Research Council Cognition and Brain Sciences Unit
1. Study Identification
Unique Protocol Identification Number
NCT04161261
Brief Title
Minimizing Facial Nerve Stimulation in Cochlear Implants
Official Title
Minimizing Facial Nerve Stimulation in Cochlear Implants
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
December 13, 2019 (Actual)
Primary Completion Date
May 3, 2022 (Anticipated)
Study Completion Date
November 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cambridge University Hospitals NHS Foundation Trust
Collaborators
University of Cambridge, Medical Research Council Cognition and Brain Sciences Unit
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cochlear Hearing Loss, Hearing Loss, Sensorineural, Hearing Loss, Facial Nerve Injury, Nerve Disorders
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
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)
Allocation
Non-Randomized
Enrollment
24 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
IntraOperative Group
Arm Type
Experimental
Arm Description
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.
Arm Title
PostOperative Group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Electrical Stimulation
Intervention Description
To measure the facial nerve stimulation threshold for one mid-array and one apical electrode of the implant using the pulse-train stimuli
Primary Outcome Measure Information:
Title
To identify stimulus parameters for cochlear implant stimulation that achieve sufficient loudness for hearing, while minimizing stimulation of the facial nerve.
Description
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 Outcome Measure Information:
Title
To increase scientific understanding of the biology of the auditory and facial nerve's responses to stimulation.
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Manohar L Bance, Professor
Organizational Affiliation
Cambridge University Hospitals NHS Foundation Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Addenbrookes Hospital
City
Cambridge
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Upon completion of study, data will be disseminated into research community anonymised. IPD will not be accessible to researchers outside the clinical care team.
Learn more about this trial
Minimizing Facial Nerve Stimulation in Cochlear Implants
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