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

Not Applicable

Completed

• Conditions: Cochlear Hearing Loss
• Interventions: Device: Cochlear implant

• Registration Number: NCT03500718
• Lead Sponsor: Jawaharlal Institute of Postgraduate Medical Education & Research

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.

Study Timeline

• Study Start: 2018-02-26
• Study First Submitted: 2018-04-02
• Study First Submitted QC: 2018-04-15
• Study First Posted: 2018-04-18
• Primary Completion: 2019-12-31
• Study Completion: 2019-12-31
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-20
• Last Update Posted: 2020-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pediatric patients with bilateral sensorineural hearing loss	Cochlear implant	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.

Primary Outcome Measures

Name	Time	Method
Changes in threshold of ECAP after cochlear implantation.	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

JIPMER; 🇮🇳 Puducherry, India