Electrocochleography Function for Monitoring Residual Hearing
ECochG
Evaluation of Intra and Post-operative Electrocochleography for the Monitoring of Residual Hearing
1 other identifier
interventional
20
1 country
1
Brief Summary
This trial is a pilot study to assess the feasibility of using Electrocochleography recorded from a cochlear implant intra-operatively in real time to monitor the progress of its insertion. Correlation between:
- 1.Observed changes in this signal during surgery and residual hearing loss post-operatively and
- 2.Recordings of this signal post-operatively and actual pure tone audiometry results will also be assessed.
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 Jan 2019
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
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 24, 2019
CompletedFirst Submitted
Initial submission to the registry
February 8, 2019
CompletedFirst Posted
Study publicly available on registry
February 20, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2021
CompletedFebruary 20, 2019
February 1, 2019
11 months
February 8, 2019
February 19, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Cochlear Microphonic Amplitude (micro volts) via Electrocochleography during Cochlear Implant Insertion
Cochlear Microphonic amplitude from real time electrocochleography using the apical cochlear implant electrode during implant insertion.
1 Year
Cochlear Microphonic Amplitude (micro volts) via Electrocochleography during post-operative audiological appointments
Cochlear Microphonic amplitude recorded from varying electrodes and at varying frequencies post-insertion during each follow-up appointment for the first year.
1 Year
Secondary Outcomes (1)
ECochG Correlations
1 Year
Study Arms (1)
Pilot Group
OTHERIntra and Post-operative Electrocochleography
Interventions
Electrocochleography measurement Intra-operatively and Post-operatively at follow-up appointments along with correlative measurements (Impedance, eCAP, PTA, Speech)
Eligibility Criteria
You may qualify if:
- Meets normal candidacy requirements for cochlear implantation
- At least 1 year of age at time of consent being given
- Patent cochlea as verified by CT or MRI scan
- No cochlear abnormality that might prevent insertion of the electrode array
- Measurable residual hearing in the ear to be implanted
- No additional complex needs that would prevent study procedures or normal clinical follow-up protocol being followed
- AB Implant selected by patient or MDT
- Written informed consent obtained
You may not qualify if:
- Medically complex cases where minimal duration of surgery is required
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hearing Implant Centre, Guy's and St Thomas' NHS Foundation Trust
London, SE1 7EH, United Kingdom
Related Publications (6)
Dalbert A, Pfiffner F, Hoesli M, Koka K, Veraguth D, Roosli C, Huber A. Assessment of Cochlear Function during Cochlear Implantation by Extra- and Intracochlear Electrocochleography. Front Neurosci. 2018 Jan 26;12:18. doi: 10.3389/fnins.2018.00018. eCollection 2018.
PMID: 29434534BACKGROUNDPienkowski M, Adunka OF, Lichtenhan JT. Editorial: New Advances in Electrocochleography for Clinical and Basic Investigation. Front Neurosci. 2018 May 8;12:310. doi: 10.3389/fnins.2018.00310. eCollection 2018. No abstract available.
PMID: 29867322BACKGROUNDKoka K, Saoji AA, Litvak LM. Electrocochleography in Cochlear Implant Recipients With Residual Hearing: Comparison With Audiometric Thresholds. Ear Hear. 2017 May/Jun;38(3):e161-e167. doi: 10.1097/AUD.0000000000000385.
PMID: 27879487BACKGROUNDO'Connell BP, Holder JT, Dwyer RT, Gifford RH, Noble JH, Bennett ML, Rivas A, Wanna GB, Haynes DS, Labadie RF. Intra- and Postoperative Electrocochleography May Be Predictive of Final Electrode Position and Postoperative Hearing Preservation. Front Neurosci. 2017 May 29;11:291. doi: 10.3389/fnins.2017.00291. eCollection 2017.
PMID: 28611574BACKGROUNDMandala M, Colletti L, Tonoli G, Colletti V. Electrocochleography during cochlear implantation for hearing preservation. Otolaryngol Head Neck Surg. 2012 May;146(5):774-81. doi: 10.1177/0194599811435895. Epub 2012 Jan 30.
PMID: 22291043BACKGROUNDSoulby A, Connor S, Jiang D, Nunn T, Boyle P, Pai I. Establishing Reproducibility and Correlation of Cochlear Microphonic Amplitude to Implant Electrode Position Using Intraoperative Electrocochleography and Postoperative Cone Beam Computed Tomography. Ear Hear. 2021 Sep/Oct;42(5):1263-1275. doi: 10.1097/AUD.0000000000001010.
PMID: 33813521DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Terry B Nunn, MSc
Head of Audiology and Consultant Clinical Scientist
- STUDY CHAIR
Dan Jiang, PhD FRCS
Professor of Otology and Auditory Implantation Surgery.
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
February 8, 2019
First Posted
February 20, 2019
Study Start
January 24, 2019
Primary Completion
January 1, 2020
Study Completion
January 1, 2021
Last Updated
February 20, 2019
Record last verified: 2019-02
Data Sharing
- IPD Sharing
- Will not share