Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT04241679 |
Other study ID # |
201910197 |
Secondary ID |
G190197 |
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
January 20, 2020 |
Est. completion date |
December 31, 2023 |
Study information
Verified date |
April 2024 |
Source |
Washington University School of Medicine |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
The Auditory Nerve Test System (ANTS) is a novel device that stimulates the auditory nerve
much like a cochlear implant. The purpose of this study is to demonstrate feasibility of the
ANTS during translabyrinthine surgery for vestibular schwannoma resection. If the auditory
nerve is kept intact, then the patients will also receive a cochlear implant at the same time
potentially alleviating the morbidities caused by a vestibular schwannoma and asymmetric
sensorineural hearing loss.
Description:
Many patients diagnosed with a vestibular schwannoma (also called acoustic neuroma)
eventually lose hearing in the afflicted ear. Improvements in magnetic resonance imaging
(MRI) have led to tumors being diagnosed at smaller sizes, however, this has not changed the
eventual demise in hearing for most patients. Hearing loss leads to tinnitus, poor sound
localization, difficulty hearing in background noise, and imbalance all of which contribute
to the decreased quality of life associated with a vestibular schwannoma diagnosis.
Some tumors may be resected while maintaining the integrity of the auditory nerve. When a
patient has hearing, the health of the auditory nerve can be monitored during the surgery
through auditory-evoked (sound) measurements. When a patient has already lost their hearing
or the surgical approach sacrifices all residual hearing, then auditory-evoked measurements
can no longer be used and there is no way to monitor the auditory nerve aside from visual
inspection.
The Auditory Nerve Test System (ANTS) is a novel device designed to facilitate
electrically-evoked auditory nerve monitoring. The ANTS is comprised of three parts: a test
electrode, connector cable, and stimulator box. The test electrode functions like a
mini-cochlear implant placed within the cochlea during a translabyrinthine surgery. During
tumor resection the test electrode electrically stimulates the auditory nerve allowing
surgeons to monitor electrophysiologic data on the health of the auditory nerve. The primary
goal of this study is to assess the ANTS during translabyrinthine vestibular schwannoma
resections.
If patient are able to maintain an intact auditory nerve following vestibular schwannoma
resection then a cochlear implant will be placed during the same surgery. Secondary outcomes
measures will investigate cochlear implant outcomes and patient quality of life following
this procedure and over the first year of using their cochlear implant. These secondary
outcomes will be measured at 3-months, 6-months, and 12-months following cochlear implant
activation. The test will assess how well the cochlear implant is working, the cochlear
implant's impact on sound localization and hearing in background noise, and finally various
aspects relevant to the patient's quality of life (tinnitus, balance, hearing, and overall
quality of life).