Auditory Nerve Test System During Vestibular Schwannoma Resection

NCT04241679 | Completed DMC FDA Device

• 2 other identifiers: 201910197G190197
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Vestibular Schwannoma; Acoustic Neuroma; Sensorineural Hearing Loss; Asymmetric Sensorineural Hearing Loss; Cochlear Nerve Damage; Cochlear Nerve Deafness; Skull Base Neoplasms; Auditory; Nerve

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Auditory Nerve Electrophysiology

  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.

  Intraoperative testing

Secondary Outcomes (3)

• Cochlear Implant Speech Performance

  3-months and 12-months after cochlear implant activation

• Sound Localization

  Initial cochlear implant activation, then repeated at 6-months and 12-months after activation.

• Quality of Life Following Vestibular Schwannoma Resection

  Pre-operative baseline, then 3-months and 12-months post-operative

Study Arms (1)

Intervention Group

EXPERIMENTAL

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

Interventions

Auditory Nerve Test System DEVICE

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.

Intervention Group

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Vestibular schwannoma (sporadic or Neurofibromastosis Type-2)
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Neuroma, Acoustic; Hearing Loss, Sensorineural; Vestibulocochlear Nerve Injuries; Retrocochlear Diseases; Skull Base Neoplasms; Vestibulocochlear Nerve Diseases

Condition Hierarchy (Ancestors)

Neurilemmoma; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neuroma; Nerve Sheath Neoplasms; Neoplasms, Nerve Tissue; Cranial Nerve Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Peripheral Nervous System Neoplasms; Ear Diseases; Otorhinolaryngologic Diseases; Otorhinolaryngologic Neoplasms; Cranial Nerve Diseases; Nervous System Diseases; Hearing Loss; Hearing Disorders; Sensation Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cranial Nerve Injuries; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Skull Neoplasms; Bone Neoplasms; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Cameron C Wick, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Single arm study of 10 patients with no serviceable hearing due to small or medium sized vestibular schwannomas undergoing translabyrinthine resection.

Study Record Dates

• First Submitted: November 5, 2019
• First Posted: January 27, 2020
• Study Start: January 20, 2020
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: April 25, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)