DeafnessNCT05248113
Intraoperative Electrically-evoked ABRs in Patients Undergoing Vestibular Schwannoma Surgery
A study testing Electrical stimulation of cochlear nerve in people with Deafness, run by University of California, Irvine at 1 site in United States.
Trial summary
This is a study of the feasibility of activating the auditory system by an electrode in direct contact with the cochlear nerve. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Deafness
- What is being tested?
- Electrical stimulation of cochlear nerve
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jan 2022to Mar 2024
- 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 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults with the diagnosis of unilateral or bilateral vestibular schwannoma proven on radiographic imaging.
- Only patients with little or no hearing ability undergoing surgical resection of the tumor will be enrolled.
Who cannot join
- Women who are pregnant
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
UC Irvine Health, Pavilion II
Orange, California, 92868
Harrison W Lin, MD, 714-456-5753, harriswl@hs.uci.edu
About this study
This is a study of the feasibility of activating the auditory system by an electrode in direct contact with the cochlear nerve.
Read the detailed description
This is a feasibility study being conducted prior to development of a penetrating cochlear nerve stimulating electrode. Experiments will be conducted in patients who are undergoing surgery for resection of a vestibular schwannoma (VS). In the normal course of such a surgical procedure, the cochlear nerve is exposed and, in many cases, the cochlear nerve is resected or function of the cochlear nerve is otherwise disrupted. Typically, recording electrodes are placed on the scalp for the purpose of recording sound-evoked auditory brainstem responses (ABRs), which serve as a measure of the functional status of the cochlear nerve. In this intraoperative experimental procedure, a conventional bipolar nerve stimulating electrode will be placed in contact with the cochlear nerve and the nerve will be stimulated with electrical pulses. Activation of the auditory system by the electrical pulses will be evaluated by measurement of electrically-evoked ABRs, using the same scalp electrodes that are typically used for measurement of sound-evoked ABRs. The cochlear-nerve stimulating electrode will be in place only during the actual intraoperative test. No device will remain in the patient. The intraoperative experimental procedure is not intended to as a therapeutic measure for the patient's VS.
- Conditions
- Deafness
- Being tested
- Electrical stimulation of cochlear nerve
- Keywords
- vestibular schwannoma, cochlear nerve, auditory prosthesis
- Medical subject headings
- Deafness, Neuroma, Acoustic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electrical stimulation of cochlear nerveDevice
Intraoperative electrical stimulation of the cochlear nerve in patients undergoing surgery for resection of vestibular schwannoma. Activation of the auditory system monitored with scalp recording of auditory brainstem response.
| Study group | Role | What they receive |
|---|---|---|
| Intraoperative electrical stimulation of cochlear nerve | Experimental | Electrical stimulation of the cochlear nerve will be tested intraoperatively in patients undergoing vestibular schwannoma resection. Receives: Device: Electrical stimulation of cochlear nerve |
What is being measured
The primary outcome is the main question the study is designed to answer.
Auditory brainstem response
Electrical potentials recorded with scalp electrodes in response to electrical stimulation of the cochlear nerve
Measured: Recorded immediately during ongoing cochlear-nerve stimulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2022
- Study start25 Jan 2022
- Primary completionMar 2024 (estimated)
- Study completionMar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DeafnessStudies of the same condition, open and under way.
- More trials run by University of California, IrvineThe 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
- Test of feasibility of electrical stimulation of the cochlear nerve with a conventional bipolar nerve stimulator
- Masking
- None (open label)
- Enrolment
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Harrison W Lin, University of California, Irvine
- Investigators
- Harrison M Lin, MD, Principal investigator, University of California, IrvineJohn C Middlebrooks, PhD, Principal investigator, University of California, Irvine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05248113
- Sponsor's protocol ID
- 2017-3885
- Status last verified
- Nov 2022
- First submitted
- 9 Feb 2022
- Last updated
- 1 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- 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 1 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Electrically-evoked ABRs in Patients Undergoing Vestibular Schwannoma Surgery
- ClinicalTrials.gov ID
- NCT05248113
- Acronym / sponsor ID
- 2017-3885
- Conditions
- Deafness
- Keywords
- vestibular schwannoma, cochlear nerve, auditory prosthesis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Study start
- 25 Jan 2022 (actual)
- Primary completion
- Mar 2024 (estimated)
- Study completion
- Mar 2024 (estimated)
- First posted
- 21 Feb 2022 (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.
This is a study of the feasibility of activating the auditory system by an electrode in direct contact with the cochlear nerve.
Detailed description
This is a feasibility study being conducted prior to development of a penetrating cochlear nerve stimulating electrode. Experiments will be conducted in patients who are undergoing surgery for resection of a vestibular schwannoma (VS). In the normal course of such a surgical procedure, the cochlear nerve is exposed and, in many cases, the cochlear nerve is resected or function of the cochlear nerve is otherwise disrupted. Typically, recording electrodes are placed on the scalp for the purpose of recording sound-evoked auditory brainstem responses (ABRs), which serve as a measure of the functional status of the cochlear nerve. In this intraoperative experimental procedure, a conventional bipolar nerve stimulating electrode will be placed in contact with the cochlear nerve and the nerve will be stimulated with electrical pulses. Activation of the auditory system by the electrical pulses will be evaluated by measurement of electrically-evoked ABRs, using the same scalp electrodes that are typically used for measurement of sound-evoked ABRs. The cochlear-nerve stimulating electrode will be in place only during the actual intraoperative test. No device will remain in the patient. The intraoperative experimental procedure is not intended to as a therapeutic measure for the patient's VS.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Test of feasibility of electrical stimulation of the cochlear nerve with a conventional bipolar nerve stimulator
| Arm | Type | Receives |
|---|---|---|
| Intraoperative electrical stimulation of cochlear nerve | Experimental | Device: Electrical stimulation of cochlear nerveElectrical stimulation of the cochlear nerve will be tested intraoperatively in patients undergoing vestibular schwannoma resection. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adults with the diagnosis of unilateral or bilateral vestibular schwannoma proven on radiographic imaging.
- Only patients with little or no hearing ability undergoing surgical resection of the tumor will be enrolled.
Key exclusion criteria (1 listed)
- Women who are pregnant
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 |
|---|---|---|
| Electrical stimulation of cochlear nerveIntraoperative electrical stimulation of the cochlear nerve in patients undergoing surgery for resection of vestibular schwannoma. Activation of the auditory system monitored with scalp recording of auditory brainstem response. | Device | Intraoperative electrical stimulation of cochlear nerve |
Primary outcome
Auditory brainstem response
Time frame: Recorded immediately during ongoing cochlear-nerve stimulation
Electrical potentials recorded with scalp electrodes in response to electrical stimulation of the cochlear nerve
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2022.
- 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.
Harrison M Lin, MD principal investigator
University of California, Irvine
John C Middlebrooks, PhD principal investigator
University of California, Irvine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electrical stimulation of cochlear nerve in people with Deafness, run by University of California, Irvine 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 2 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 1 Dec 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Harrison W Lin, MD (714 456 5753, harriswl@hs.uci.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Auditory brainstem response (time frame: Recorded immediately during ongoing cochlear-nerve stimulation). 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 1 Dec 2022.