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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03500718
Enrollment
44
Registered
2018-04-18
Start date
2018-02-26
Completion date
2019-12-31
Last updated
2020-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cochlear Hearing Loss

Keywords

cochlear implant, threshold of electrically evoked compound action potential, neural response telemetry

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.

Interventions

DEVICECochlear implant

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).

Sponsors

Jawaharlal Institute of Postgraduate Medical Education & Research
Lead SponsorOTHER_GOV

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
1 Years to 6 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
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

MeasureTime frameDescription
Correlate the amplitude of ECAP with T & C levels.2 yearsCorrelating the amplitude of ECAP with threshold and comfortable levels and creating a MAP.
Correlate amplitude of ECAP with cochlear nerve diameter measured pre-operatively.2 minsBy correlating amplitude of ECAP with cochlear nerve diameter we can determine the site to be operated preoperatively.

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026