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Completed

NCT Number: NCT03500718

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

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.

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Key information

Conditions

Cochlear Hearing Loss Ear Diseases Hearing Disorders Hearing Loss Hearing Loss, Sensorineural Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms

Age range

1 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

JIPMER

Puducherry, 605006, India

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cochlear Implant

Device

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 outcomes

  1. 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.

Secondary outcomes

  1. 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. 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.

Sponsors and collaborators

Lead sponsor

Jawaharlal Institute of Postgraduate Medical Education & Research

Other Gov

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Apr 18, 2018
Registry last updated
Feb 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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