CompletedNot Applicable

Auditory Nerve Test System During Vestibular Schwannoma Resection

United States10 participantsStarted 2020-01-20

Plain-language 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.

Who can participate

Age range

12 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Auditory Nerve Electrophysiology

Timeframe: Intraoperative testing

Trial details

NCT IDNCT04241679

SponsorWashington University School of Medicine

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-12-31

View on ClinicalTrials.gov More Vestibular Schwannoma trials