Ignite Creation Date:
2025-12-24 @ 12:34 PM
Ignite Modification Date:
2026-02-25 @ 8:47 PM
Study NCT ID:
NCT04161261
Status:
UNKNOWN
Last Update Posted:
2021-07-29
First Post:
2019-11-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Minimizing Facial Nerve Stimulation in Cochlear Implants
Sponsor:
Cambridge University Hospitals NHS Foundation Trust
Organization:
Study Overview
Official Title:
Minimizing Facial Nerve Stimulation in Cochlear Implants
Status:
UNKNOWN
Status Verified Date:
2021-07
Last Known Status:
ENROLLING_BY_INVITATION
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: