Auditory Nerve Test System During Vestibular Schwannoma Resection

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 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

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