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

Primary Purpose

Cochlear Hearing Loss

Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Cochlear implant
Sponsored by
Jawaharlal Institute of Postgraduate Medical Education & Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cochlear Hearing Loss focused on measuring cochlear implant, threshold of electrically evoked compound action potential, neural response telemetry

Eligibility Criteria

1 Year - 6 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • JIPMER

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Pediatric patients with bilateral sensorineural hearing loss

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Correlate the amplitude of ECAP with T & C levels.
Correlating the amplitude of ECAP with threshold and comfortable levels and creating a MAP.
Correlate amplitude of ECAP with cochlear nerve diameter measured pre-operatively.
By correlating amplitude of ECAP with cochlear nerve diameter we can determine the site to be operated preoperatively.

Full Information

First Posted
April 2, 2018
Last Updated
February 20, 2020
Sponsor
Jawaharlal Institute of Postgraduate Medical Education & Research
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1. Study Identification

Unique Protocol Identification Number
NCT03500718
Brief Title
Changes in the Threshold of Electrically Evoked Compound Action Potential in Children Following Cochlear Implantation
Official Title
Changes in the Threshold of Electrically Evoked Compound Action Potential in Children Following Cochlear Implantation
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
February 26, 2018 (Actual)
Primary Completion Date
December 31, 2019 (Actual)
Study Completion Date
December 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Jawaharlal Institute of Postgraduate Medical Education & Research

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cochlear Hearing Loss
Keywords
cochlear implant, threshold of electrically evoked compound action potential, neural response telemetry

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pediatric patients with bilateral sensorineural hearing loss
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Cochlear implant
Intervention 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).
Primary Outcome Measure Information:
Title
Changes in threshold of ECAP after cochlear implantation.
Description
To evaluate changes in threshold of ECAP during cochlear implantation, at switch on( 4 weeks), after 3 months and 6 months following cochlear implantation.
Time Frame
during implantation, at switch on( 4 weeks), after 3months and 6months.
Secondary Outcome Measure Information:
Title
Correlate the amplitude of ECAP with T & C levels.
Description
Correlating the amplitude of ECAP with threshold and comfortable levels and creating a MAP.
Time Frame
2 years
Title
Correlate amplitude of ECAP with cochlear nerve diameter measured pre-operatively.
Description
By correlating amplitude of ECAP with cochlear nerve diameter we can determine the site to be operated preoperatively.
Time Frame
2 mins

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
JIPMER
City
Puducherry
ZIP/Postal Code
605006
Country
India

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing 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.
Citations:
PubMed Identifier
20634770
Citation
Kim JR, Abbas PJ, Brown CJ, Etler CP, O'Brien S, Kim LS. The relationship between electrically evoked compound action potential and speech perception: a study in cochlear implant users with short electrode array. Otol Neurotol. 2010 Sep;31(7):1041-8. doi: 10.1097/MAO.0b013e3181ec1d92.
Results Reference
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PubMed Identifier
27804133
Citation
van Eijl RH, Buitenhuis PJ, Stegeman I, Klis SF, Grolman W. Systematic review of compound action potentials as predictors for cochlear implant performance. Laryngoscope. 2017 Feb;127(2):476-487. doi: 10.1002/lary.26154. Epub 2016 Nov 2.
Results Reference
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Changes in the Threshold of Electrically Evoked Compound Action Potential in Children Following Cochlear Implantation

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