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

Cochlear Hearing Loss Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03500718
• Other study ID #: JIP/IEC/2017/0339
• Status: Completed
• Phase: N/A
• Start date: February 26, 2018
• Est. completion date: December 31, 2019

Study information

• Verified date: February 2020
• Source: Jawaharlal Institute of Postgraduate Medical Education & Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Year to 6 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cochlear Hearing Loss
• Hearing Loss
• Hearing Loss, Sensorineural

Intervention

Device:
• Cochlear 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).

Locations

Country	Name	City	State
India	JIPMER	Puducherry

Sponsors (1)

Lead Sponsor	Collaborator
Jawaharlal Institute of Postgraduate Medical Education & Research

Country where clinical trial is conducted

India, 

References & Publications (2)

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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in threshold of ECAP after cochlear implantation.	To evaluate changes in threshold of ECAP during cochlear implantation, at switch on( 4 weeks), after 3 months and 6 months following cochlear implantation.	during implantation, at switch on( 4 weeks), after 3months and 6months.
Secondary	Correlate the amplitude of ECAP with T & C levels.	Correlating the amplitude of ECAP with threshold and comfortable levels and creating a MAP.	2 years
Secondary	Correlate amplitude of ECAP with cochlear nerve diameter measured pre-operatively.	By correlating amplitude of ECAP with cochlear nerve diameter we can determine the site to be operated preoperatively.	2 mins