Changes in the Threshold of Electrically Evoked Compound Action Potential in Children Following Cochlear Implantation

Jawaharlal Institute of Postgraduate Medical Education & Research1 site in 1 country44 target enrollmentFebruary 26, 2018

Overview

Brief Summary

After cochlear implantation, cochlear nerve is stimulated by giving a current over the electrodes placed in the cochlea and the current is measured by electrically evoked Compound Action Potential (ECAP).This ECAP is measured intra operatively, after 4 weeks( at switch on), after 3months and 6 months following cochlear implantation.

Detailed Description

After cochlear implantation, cochlear nerve is stimulated by giving a current over the electrodes placed in the cochlea and the current is measured by electrically evoked Compound Action Potential (ECAP).This ECAP is measured intra operatively, 4 weeks(at switch on) and after 3months and 6 months following cochlear implantation. Neural Response Telemetry (NRT) is a quick and non-invasive way of recording ECAP of the peripheral auditory nerves in-situ. It gives clinicians valuable information for programming the T- (Threshold) and C-(Comfort) - levels of the recipient's speech processor map. Intraoperative NRT in conjunction with electrode impedance data can help indicate the integrity of the implanted electrodes and the electrode/auditory nerve interface, confirming that the implant is functioning correctly intraoperatively.

Registry

clinicaltrials.gov

Start Date

February 26, 2018

End Date

December 31, 2019

Last Updated

6 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Jawaharlal Institute of Postgraduate Medical Education & Research

Responsible Party

Principal Investigator

Dr. Aparna Das

JUNIOR RESIDENT

Jawaharlal Institute of Postgraduate Medical Education & Research

Eligibility Criteria

Inclusion Criteria

•All children between 1 and 6 years of age undergoing cochlear implantation in JIPMER during the study period.

Exclusion Criteria

•Incomplete electrode array insertion.

Outcomes

Primary Outcomes

Changes in threshold of ECAP after cochlear implantation.

Time Frame: during implantation, at switch on( 4 weeks), after 3months and 6months.

To evaluate changes in threshold of ECAP during cochlear implantation, at switch on( 4 weeks), after 3 months and 6 months following cochlear implantation.