Recruiting

Intraoperative ABRs

Sponsor:

UCLA

Code:

NCT05248113

Conditions

Deafness

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Electrical stimulation of cochlear nerve

Study Details

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

Study ID

NCT05248113

Start date

Jan 25, 2022

Status verified date

Nov, 2022

Completion date

Mar, 2024

Anticipated

Primary completion date

Mar, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Women who are pregnant

Study Design

Enrollment

8 participants

Anticipated

Intervention Model

Single group

Primary purpose

Device Feasibility

Interventions and Outcome Measures

Arms

experimental: Intraoperative electrical stimulation of cochlear nerve

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

Interventions

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.

Primary outcome measure

  • Auditory brainstem response [ Time Frame: Recorded immediately during ongoing cochlear-nerve stimulation ]

Central Contacts and Locations

Central contacts

Harrison W Lin, MD

714 456 5753harriswl@hs.uci.edu

John C Middlebrooks, PhD

949 910 0333middlebj@hs.uci.edu

Locations

UC Irvine Health, Pavilion II

Recruiting

Orange, California, United States, 92868

Contacts

Harrison W Lin, MD

714-456-5753harriswl@hs.uci.edu

More Information

Sponsor

University of California, Irvine

Last update posted

Dec 1, 2022

Last verified

Nov, 2022

Keywords

  • vestibular schwannoma
  • cochlear nerve
  • auditory prosthesis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, Irvine on 2022-12-01.