Clinical trial NCT04161261: Minimizing Facial Nerve Stimulation in Cochlear Implants
Official title: Minimizing Facial Nerve Stimulation in Cochlear Implants
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cochlear Hearing Loss
Hearing Loss, Sensorineural
Hearing Loss
Facial Nerve Injury
Nerve Disorders
Lead sponsor: Cambridge University Hospitals NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: University of Cambridge
name: Medical Research Council Cognition and Brain Sciences Unit
First posted: 2019-11-13
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention 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
Primary purpose: DIAGNOSTIC

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

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

Primary outcomes:
measure: To identify stimulus parameters for cochlear implant stimulation that achieve sufficient loudness for hearing, while minimizing stimulation of the facial nerve.
timeFrame: 18 months
Secondary outcomes:
measure: To increase scientific understanding of the biology of the auditory and facial nerve's responses to stimulation.
timeFrame: 18 months
Other outcomes:
Locations:
city: Cambridge
country: United Kingdom
facility: Addenbrookes Hospital
Study officials:
affiliation: Cambridge University Hospitals NHS Foundation Trust
name: Manohar L Bance, Professor
role: PRINCIPAL_INVESTIGATOR
References: