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

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ClinicalTrials.gov Identifier: NCT03500718
Recruitment Status : Recruiting
First Posted : April 17, 2018
Last Update Posted : April 17, 2018
Sponsor:
Information provided by (Responsible Party):
Dr. Aparna Das, Jawaharlal Institute of Postgraduate Medical Education & Research

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
Cochlear Hearing Loss Device: Cochlear implant Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 44 participants
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 : February 26, 2018
Estimated Primary Completion Date : November 30, 2019
Estimated Study Completion Date : November 30, 2019

Resource links provided by the National Library of Medicine


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).




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   1 Year to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03500718


Contacts
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Contact: Aparna Das, MS ENT 9940962997 aparnadas97@gmail.com
Contact: Arun Alexander, MS ENT 9443021595 arunalexandercmc@gmail.com

Locations
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India
JIPMER Recruiting
Puducherry, India, 605006
Contact: Aparna Das    9940962997    aparnadas97@gmail.com   
Contact: Arun Alexander    9443021595    arunalexandercmc@gmail.com   
Principal Investigator: Aparna Das         
Sub-Investigator: Arun Alexander         
Sponsors and Collaborators
Jawaharlal Institute of Postgraduate Medical Education & Research

Publications:
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Responsible Party: Dr. Aparna Das, JUNIOR RESIDENT, Jawaharlal Institute of Postgraduate Medical Education & Research
ClinicalTrials.gov Identifier: NCT03500718     History of Changes
Other Study ID Numbers: JIP/IEC/2017/0339
First Posted: April 17, 2018    Key Record Dates
Last Update Posted: April 17, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Confidentiality regarding patient's participation in the study will be maintained throughout the study period as well as after completion of the study.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Dr. Aparna Das, Jawaharlal Institute of Postgraduate Medical Education & Research:
cochlear implant
threshold of electrically evoked compound action potential
neural response telemetry

Additional relevant MeSH terms:
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Hearing Loss
Hearing Loss, Sensorineural
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms