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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Cochlear Hearing Loss

Intervention / Treatment
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* Device: Cochlear implant


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 6 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pediatric patients with bilateral sensorineural hearing loss<br>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<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | By correlating amplitude of ECAP with cochlear nerve diameter we can determine the site to be operated preoperatively. | 2 mins | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cochlear implant, threshold of electrically evoked compound action potential, neural response telemetry