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

February 20, 2020 updated by: Dr. Aparna Das, Jawaharlal Institute of Postgraduate Medical Education & Research
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
      • Puducherry, India, 605006
        • JIPMER

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 6 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Pediatric patients with bilateral sensorineural hearing loss
One group will be studied: Patients undergoing cochlear implantation surgery between age 1 and 6 years who meet the above inclusion and exclusion criteria seen in JIPMER during the study period.
Device: Cochlear implant
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).

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlate the amplitude of ECAP with T & C levels.
Time Frame: 2 years
Correlating the amplitude of ECAP with threshold and comfortable levels and creating a MAP.
2 years
Correlate amplitude of ECAP with cochlear nerve diameter measured pre-operatively.
Time Frame: 2 mins
By correlating amplitude of ECAP with cochlear nerve diameter we can determine the site to be operated preoperatively.
2 mins

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jawaharlal Institute of Postgraduate Medical Education & Research

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 26, 2018

Primary Completion (ACTUAL)

December 31, 2019

Study Completion (ACTUAL)

December 31, 2019

Study Registration Dates

First Submitted

April 2, 2018

First Submitted That Met QC Criteria

April 15, 2018

First Posted (ACTUAL)

April 18, 2018

Study Record Updates

Last Update Posted (ACTUAL)

February 24, 2020

Last Update Submitted That Met QC Criteria

February 20, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JIP/IEC/2017/0339

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Confidentiality regarding patient's participation in the study will be maintained throughout the study period as well as after completion of the study.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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