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

Sponsor
Jawaharlal Institute of Postgraduate Medical Education & Research (Other)
Overall Status
Completed
CT.gov ID
NCT03500718
Collaborator
(none)
44
1
1
22.1
2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Cochlear implant
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
44 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Changes in the Threshold of Electrically Evoked Compound Action Potential in Children Following Cochlear Implantation
Actual Study Start Date :
Feb 26, 2018
Actual Primary Completion Date :
Dec 31, 2019
Actual Study Completion Date :
Dec 31, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: Pediatric patients with bilateral sensorineural hearing loss

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.

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).

Outcome Measures

Primary Outcome Measures

  1. 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 Outcome Measures

  1. Correlate the amplitude of ECAP with T & C levels. [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. [2 mins]

    By correlating amplitude of ECAP with cochlear nerve diameter we can determine the site to be operated preoperatively.

Eligibility Criteria

Criteria

Ages Eligible for Study:
1 Year to 6 Years
Sexes Eligible for Study:
All
Accepts 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 JIPMER Puducherry India 605006

Sponsors and Collaborators

  • Jawaharlal Institute of Postgraduate Medical Education & Research

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Dr. Aparna Das, JUNIOR RESIDENT, Jawaharlal Institute of Postgraduate Medical Education & Research
ClinicalTrials.gov Identifier:
NCT03500718
Other Study ID Numbers:
  • JIP/IEC/2017/0339
First Posted:
Apr 18, 2018
Last Update Posted:
Feb 24, 2020
Last Verified:
Feb 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Dr. Aparna Das, JUNIOR RESIDENT, Jawaharlal Institute of Postgraduate Medical Education & Research
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 24, 2020