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

Jawaharlal Institute of Postgraduate Medical Education & Research

Status: Completed

Conditions: Cochlear Hearing Loss

Treatments: Device: Cochlear implant

Study type: Interventional

Funder types: Other

Identifiers

NCT03500718

JIP/IEC/2017/0339

Details and patient eligibility

About

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.

Full 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.

Enrollment: 44 patients

Sex: All

Ages: 1 to 6 years old

Volunteers: Accepts 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

44 participants in 1 patient group

Pediatric patients with bilateral sensorineural hearing loss

Experimental group

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.

Treatment:

Device: Cochlear implant