Intraoperative Electrically-evoked ABRs in Patients Undergoing Vestibular Schwannoma Surgery

NCT05248113 | Unknown FDA Device

• 1 other identifier: 2017-3885
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

This is a study of the feasibility of activating the auditory system by an electrode in direct contact with the cochlear nerve.

Conditions

Deafness

Keywords

vestibular schwannoma; cochlear nerve; auditory prosthesis

Outcome Measures

Primary Outcomes (1)

• Auditory brainstem response

  Electrical potentials recorded with scalp electrodes in response to electrical stimulation of the cochlear nerve

  Recorded immediately during ongoing cochlear-nerve stimulation

Study Arms (1)

Intraoperative electrical stimulation of cochlear nerve

EXPERIMENTAL

Electrical stimulation of the cochlear nerve will be tested intraoperatively in patients undergoing vestibular schwannoma resection.

Device: Electrical stimulation of cochlear nerve

Interventions

Electrical stimulation of cochlear nerve DEVICE

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.

Intraoperative electrical stimulation of cochlear nerve

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Women who are pregnant

Sponsors & Collaborators

• University of California, Irvine: lead

Study Sites (1)

UC Irvine Health, Pavilion II

Orange, California, 92868, United States

RECRUITING

MeSH Terms

Conditions

Deafness; Neuroma, Acoustic

Condition Hierarchy (Ancestors)

Hearing Loss; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; 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; Vestibulocochlear Nerve Diseases; Retrocochlear Diseases; Otorhinolaryngologic Neoplasms; Cranial Nerve Diseases

Study Officials

• Harrison M Lin, MD

  University of California, Irvine

  PRINCIPAL INVESTIGATOR

• John C Middlebrooks, PhD

  University of California, Irvine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Harrison W Lin, MD

CONTACT

714 456 5753; harriswl@hs.uci.edu

John C Middlebrooks, PhD

CONTACT

949 910 0333; middlebj@hs.uci.edu

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: Associate Professor

Model Details: Test of feasibility of electrical stimulation of the cochlear nerve with a conventional bipolar nerve stimulator

Study Record Dates

• First Submitted: February 9, 2022
• First Posted: February 21, 2022
• Study Start: January 25, 2022
• Primary Completion: March 1, 2024
• Study Completion: March 1, 2024
• Last Updated: December 1, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)