Brief Title
Auditory Nerve Test System During Vestibular Schwannoma Resection
Official Title
Feasibility of Auditory Nerve Test System for Optimization of Simultaneous Translabyrinthine Vestibular Schwannoma Resection With Cochlear Implantation
Brief 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.
Detailed 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).
Study Type
Interventional
Primary Outcome
Auditory Nerve Electrophysiology
Secondary Outcome
Cochlear Implant Speech Performance
Condition
Vestibular Schwannoma
Intervention
Auditory Nerve Test System
Study Arms / Comparison Groups
Intervention Group
Description: Patients undergoing a translabyrinthine approach for vestibular schwannoma resection will have the health of their auditory nerve monitored during tumor dissection. If the auditory nerve is visually confirmed to be intact, then concurrent cochlear implantation will be performed.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
5
Start Date
January 20, 2020
Completion Date
June 30, 2021
Primary Completion Date
June 30, 2021
Eligibility Criteria
Inclusion Criteria: - Vestibular schwannoma (sporadic or Neurofibromastosis Type-2) - 12 years of age or older - Tumor size < 2.5 cm - Non-serviceable ipsilateral hearing - No prior cochlear implant or auditory brainstem implant use - No prior microsurgery or stereotactic radiation for this tumor - Patient decision and medical clearance for a translabyrinthine approach for tumor resection - Willingness to comply with research protocol - Reasonable expectations of cochlear implant performance - Auditory nerve integrity visually confirmed following tumor resection Exclusion Criteria: - Pathology/tumors other than a vestibular schwannoma - Younger than 12 years of age - Tumor size > 2.5 cm - Serviceable hearing in the tumor ear - Prior cochlear implant use in either the contralateral or ipsilateral ear - Prior microsurgery or stereotactic radiation for this tumor - Unwilling to comply with research protocol - Auditory nerve integrity cannot be visually confirmed after tumor resection
Gender
All
Ages
12 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Cameron C Wick, MD, 314-273-1589, [email protected]
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT04241679
Organization ID
201910197
Secondary IDs
G190197
Responsible Party
Principal Investigator
Study Sponsor
Washington University School of Medicine
Study Sponsor
Cameron C Wick, MD, Principal Investigator, Washington University School of Medicine
Verification Date
January 2020