Clinical trial NCT03500718: Changes in the Threshold of Electrically Evoked Compound Action Potential in Children Following Cochlear Implantation
Official title: Changes in the Threshold of Electrically Evoked Compound Action Potential in Children Following Cochlear Implantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cochlear Hearing Loss
Keywords: cochlear implant
threshold of electrically evoked compound action potential
neural response telemetry
Lead sponsor: Jawaharlal Institute of Postgraduate Medical Education & Research
Sponsor class: OTHER_GOV
First posted: 2018-04-18
Enrollment: 44
Sex: ALL
Minimum age (years): 1
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Changes in threshold of ECAP after cochlear implantation.
timeFrame: during implantation, at switch on( 4 weeks), after 3months and 6months.
Secondary outcomes:
measure: Correlate the amplitude of ECAP with T & C levels.
timeFrame: 2 years
measure: Correlate amplitude of ECAP with cochlear nerve diameter measured pre-operatively.
timeFrame: 2 mins
Other outcomes:
Locations:
city: Puducherry
country: India
facility: JIPMER
Study officials:
References:
citation: Kim JR, Abbas PJ, Brown CJ, Etler CP, O'Brien S, Kim LS. The relationship between electrically evoked compound action potential and speech perception: a study in cochlear implant users with short electrode array. Otol Neurotol. 2010 Sep;31(7):1041-8. doi: 10.1097/MAO.0b013e3181ec1d92.
citation: van Eijl RH, Buitenhuis PJ, Stegeman I, Klis SF, Grolman W. Systematic review of compound action potentials as predictors for cochlear implant performance. Laryngoscope. 2017 Feb;127(2):476-487. doi: 10.1002/lary.26154. Epub 2016 Nov 2.