Auditory Nerve Test System During Vestibular Schwannoma Resection (ANTS)

• ClinicalTrials.gov Identifier: NCT04241679
• Recruitment Status: Active, not recruiting
• First Posted: January 27, 2020
• Last Update Posted: December 12, 2022
• Sponsor: Washington University School of Medicine
• Information provided by (Responsible Party): Cameron Wick, Washington University School of Medicine

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Vestibular Schwannoma; Acoustic Neuroma; Sensorineural Hearing Loss; Asymmetric Sensorineural Hearing Loss; Cochlear Nerve Damage; Cochlear Nerve Deafness; Skull Base Neoplasms; Auditory; Nerve	Device: Auditory Nerve Test System	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 10 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: Single arm study of 10 patients with no serviceable hearing due to small or medium sized vestibular schwannomas undergoing translabyrinthine resection.
• Masking: None (Open Label)
• Primary Purpose: Device Feasibility
• Official Title: Feasibility of Auditory Nerve Test System for Optimization of Simultaneous Translabyrinthine Vestibular Schwannoma Resection With Cochlear Implantation
• Actual Study Start Date: January 20, 2020
• Estimated Primary Completion Date: November 30, 2023
• Estimated Study Completion Date: December 31, 2023

Arms and Interventions

Arm

Intervention/treatment

Experimental: Intervention Group; 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.

Device: Auditory Nerve Test System; The Auditory Nerve Test System provides an electrically-evoked signal from within the cochlea to facilitate intraoperative auditory nerve monitoring. The auditory nerve can be measured both at the root entry zone of the brainstem (eCNAP) and with scalp electrodes (eABR). Data on the health of the auditory nerve will be collected immediately prior to tumor dissection, during tumor dissection, and immediately after tumor dissection. The main purpose of this study is to determine feasibility of this novel intraoperative monitoring protocol. Secondarily, if the auditory nerve is visually confirmed to be intact following tumor resection then the patients will receive a cochlear implant during the same surgery.

Outcome Measures

Primary Outcome Measures :

1. Auditory Nerve Electrophysiology [ Time Frame: Intraoperative testing ]
   Reliability of electrically-evoked direct auditory nerve monitoring at the brainstem (eCNAP) and far-field auditory brainstem response (eABR). The auditory nerve signal will be monitored before, during, and after vestibular schwannoma resection. Elements like signal amplitude, latency, and preservation of eABR waveforms III and V will be measured.

Secondary Outcome Measures :

1. Cochlear Implant Speech Performance [ Time Frame: 3-months and 12-months after cochlear implant activation ]
   Speech performance measured in the CI-only condition using CNC Words, AzBio Sentences in Quiet, and AzBio Sentences in +10 dB SNR.
2. Sound Localization [ Time Frame: Initial cochlear implant activation, then repeated at 6-months and 12-months after activation. ]
   Using an audio booth that contains a sound arc, patients will be asked to identify where a sound is coming from in the implant-on and implant-off conditions. This ability to localize is measured with a root-mean-square (RMS) error rate.
3. Quality of Life Following Vestibular Schwannoma Resection [ Time Frame: Pre-operative baseline, then 3-months and 12-months post-operative ]
   Diagnosis and treatment of vestibular schwannomas can impact multiple aspects of a patient's quality of life. Using patient-reported outcome measures these aspects will be measured throughout their treatment course. The specific questionnaires will be: Speech, Spatial and Qualities of Hearing (SSQ), Hearing Handicap Inventory for Adults (HHIA), Tinnitus Handicap Inventory (THI), Dizziness Handicap Inventory (DHI), Penn Acoustic Neuroma Quality of Life (PANQOL), Cochlear Implant Quality of Life (CIQOL).

Eligibility Criteria

• Ages Eligible for Study: 12 Years and older (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, Missouri

Washington University

Saint Louis, Missouri, United States, 63110

Sponsors and Collaborators

Washington University School of Medicine

Investigators

• Principal Investigator: Cameron C Wick, MD; Washington University School of Medicine

More Information

• Responsible Party: Cameron Wick, Assistant Professor, Washington University School of Medicine
• ClinicalTrials.gov Identifier: NCT04241679
• Other Study ID Numbers: 201910197; G190197 ( Other Identifier: FDA - Investigational Device Exemption )
• First Posted: January 27, 2020
• Last Update Posted: December 12, 2022
• Last Verified: December 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Device Product Not Approved or Cleared by U.S. FDA: Yes

Keywords provided by Cameron Wick, Washington University School of Medicine:

Cochlear implant; Vestibular schwannoma; Acoustic Neuroma; Sensorineural hearing loss; Asymmetric sensorineural hearing loss; Single-sided deafness; Auditory nerve

Additional relevant MeSH terms:

Neurilemmoma; Neuroma; Neuroma, Acoustic; Skull Base Neoplasms; Hearing Loss; Deafness; Hearing Loss, Sensorineural; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Nerve Sheath Neoplasms; Neoplasms, Nerve Tissue; Cranial Nerve Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Peripheral Nervous System Neoplasms; Vestibulocochlear Nerve Diseases; Retrocochlear Diseases; Otorhinolaryngologic Neoplasms; Cranial Nerve Diseases; Skull Neoplasms; Bone Neoplasms