Vestibular SchwannomaANTSNCT04241679
Auditory Nerve Test System During Vestibular Schwannoma Resection
A study testing Auditory Nerve Test System in people with Vestibular Schwannoma and Acoustic Neuroma, run by Washington University School of Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Vestibular Schwannoma, Acoustic Neuroma, Sensorineural Hearing Loss
- What is being tested?
- Auditory Nerve Test System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jan 2020to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility of Auditory Nerve Test System for Optimization of Simultaneous Translabyrinthine Vestibular Schwannoma Resection With Cochlear Implantation
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.
Read the 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).
- Conditions
- Vestibular Schwannoma, Acoustic Neuroma, Sensorineural Hearing Loss, Asymmetric Sensorineural Hearing Loss, Cochlear Nerve Damage, Cochlear Nerve Deafness
- Being tested
- Auditory Nerve Test System
- Keywords
- Cochlear implant, Vestibular schwannoma, Acoustic Neuroma, Sensorineural hearing loss, Asymmetric sensorineural hearing loss, Single-sided deafness, Auditory nerve
- Medical subject headings
- Neuroma, Acoustic, Hearing Loss, Sensorineural, Vestibulocochlear Nerve Injuries, Retrocochlear Diseases, Skull Base Neoplasms, Vestibulocochlear Nerve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Auditory Nerve Test SystemDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Auditory Nerve Test System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Intraoperative testing
Secondary outcomes (3)
Cochlear Implant Speech Performance
Speech performance measured in the CI-only condition using CNC Words, AzBio Sentences in Quiet, and AzBio Sentences in +10 dB SNR.
Measured: 3-months and 12-months after cochlear implant activation
Sound Localization
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.
Measured: Initial cochlear implant activation, then repeated at 6-months and 12-months after activation.
Quality of Life Following Vestibular Schwannoma Resection
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).
Measured: Pre-operative baseline, then 3-months and 12-months post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2020
- Study start20 Jan 2020
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vestibular SchwannomaStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cameron Wick, Washington University School of Medicine
- Investigators
- Cameron C Wick, MD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04241679
- Sponsor's protocol ID
- 201910197
- Other IDs
- G190197
- Acronym
- ANTS
- Status last verified
- Apr 2024
- First submitted
- 5 Nov 2019
- Last updated
- 25 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Auditory Nerve Test System for Optimization of Simultaneous Translabyrinthine Vestibular Schwannoma Resection With Cochlear Implantation
- ClinicalTrials.gov ID
- NCT04241679
- Acronym / sponsor ID
- ANTS / 201910197
- Conditions
- Vestibular Schwannoma, Acoustic Neuroma, Sensorineural Hearing Loss, Asymmetric Sensorineural Hearing Loss, Cochlear Nerve Damage, Cochlear Nerve Deafness
- Keywords
- Cochlear implant, Vestibular schwannoma, Acoustic Neuroma, Sensorineural hearing loss, Asymmetric sensorineural hearing loss, Single-sided deafness, Auditory nerve
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 20 Jan 2020 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 27 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single arm study of 10 patients with no serviceable hearing due to small or medium sized vestibular schwannomas undergoing translabyrinthine resection.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Device: Auditory Nerve Test SystemPatients 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. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Auditory Nerve Test SystemThe 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. | Device | Intervention Group |
Primary outcome
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.
3 secondary outcomes
Cochlear Implant Speech Performance
Time frame: 3-months and 12-months after cochlear implant activation
Sound Localization
Time frame: Initial cochlear implant activation, then repeated at 6-months and 12-months after activation.
Quality of Life Following Vestibular Schwannoma Resection
Time frame: Pre-operative baseline, then 3-months and 12-months post-operative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cameron C Wick, MD principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Auditory Nerve Test System in people with Vestibular Schwannoma and Acoustic Neuroma, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Auditory Nerve Electrophysiology (time frame: Intraoperative testing). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2024.