Extra-cochlear Electrode Placement at the Post-auricular Vagus Nerve in Cochlear Implantation
Single-center Non-inferiority Study of Extra-cochlear Electrode Placement at the Post-auricular Vagus Nerve in Cochlear Implantation
1 other identifier
interventional
12
1 country
1
Brief Summary
This study will evaluate hearing outcomes after cochlear implantation with placement of the ECE1 ground electrode near the post-auricular vagus nerve (Arnold's nerve) to assess non-inferiority with respect to placement under the temporalis muscle.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2025
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 2, 2025
CompletedFirst Posted
Study publicly available on registry
June 10, 2025
CompletedStudy Start
First participant enrolled
October 17, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 1, 2028
May 1, 2026
April 1, 2026
2.7 years
June 2, 2025
April 27, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
AzBio Sentence Recognition Test Score
The AzBio Sentence Recognition Test is a clinical tool used to evaluate a person's ability to understand speech in noisy environments. The total score is the percentage of words correctly understood, ranging from 0-100%.
Up to Year 1 post cochlear implant activation
Study Arms (1)
Patients scheduled for Cochlear Implantation
EXPERIMENTALThe experimental arm will enroll patients over the age of 18 undergoing cochlear implantation involving the placement of ECE1 at the approximate location of Arnold's nerve within the ear canal. In the proposed study, a modification to the surgical approach will be done to place ECE1 near Arnold's nerve, while still using a standard electrode array.
Interventions
Eligible Cochlear Americas devices eligible for inclusion in this study include any Cochlear Americas device that has two ground electrodes.
Implant procedure will be modified to place ground electrode (ECE1) near Arnold's nerve.
Eligibility Criteria
You may qualify if:
- will be undergoing surgery for a cochlear implant from Cochlear Americas
- is willing to participate in the study
You may not qualify if:
- has history of prior ear surgery, congenital ear malformation, or prior cochlear implantation in the ear to be implanted
- pregnant, planning to become pregnant, or breastfeeding patients cannot undergo the standard-of-care implantation procedures required for participation in the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
NYU Langone Health
New York, New York, 10016, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
J. Thomas Roland, Jr., MD
NYU Langone Health
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 2, 2025
First Posted
June 10, 2025
Study Start
October 17, 2025
Primary Completion (Estimated)
July 1, 2028
Study Completion (Estimated)
July 1, 2028
Last Updated
May 1, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
- Access Criteria
- The investigator who proposed to use the data will be granted access upon reasonable request. Requests should be directed to mario.svirsky@nyulangone.org. To gain access, data requestors will need to sign a data access agreement. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's DSSB.
The de-identified participant data from the final research dataset will be shared upon reasonable request beginning 9 to 36 months after publication or as required by a condition of awards or supporting agreements, provided the requesting investigator executes a data use agreement with NYU Langone Health. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's Data Sharing Strategy Board (DSSB). Requests should be directed to: mario.svirsky@nyulangone.org. The protocol and statistical analysis plan will be posted on Clinicaltrials.gov only as required by federal regulation or supporting awards and agreements.