Intraoperative Electrically-evoked ABRs in Patients Undergoing Vestibular Schwannoma Surgery
NCT05248113 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 8
Last updated 2022-12-01
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
Interventions
- DEVICE
-
Electrical stimulation of cochlear nerve
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.
Sponsors & Collaborators
-
University of California, Irvine
lead OTHER
Principal Investigators
-
Harrison M Lin, MD · University of California, Irvine
-
John C Middlebrooks, PhD · University of California, Irvine
Study Design
- Allocation
- NA
- Purpose
- DEVICE_FEASIBILITY
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 99 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-01-25
- Primary Completion
- 2024-03-31
- Completion
- 2024-03-31
- FDA Device
- Yes
Countries
- United States
Study Locations
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