Correlation Between NRT and Radiological Measurements in Detection of Position of the Electrode Inside the Cochlea.

October 9, 2017 updated by: samah hamdy saeed, Assiut University

Correlation Between the Neural Response Telemetry (NRT) and Radiological Measurements in Detection of Position of the Electrode Inside the Cochlea

The study will be conducted as Prospective study including 50 patients (aged <6years ) at Otorhinolaryngology department, Assuit University Hospital (aged <6years ) who will undergo cochlear implantation. All subjects will undergo implantation with Medel sonata flex 28 or standard electrodes with a standard surgical procedure. The standard surgical procedure will include extended end aural approach ,posterior tympanotomy and a round window insertion.The results of immediate postoperative Neural Response Telemetry (NRT) measurements & postoperative CT imaging will be obtained.

Each patient will be subjected to the following scheme:

immediate postoperative Neural Response Telemetry (NRT) measurements
postoperative CT imaging
Data obtained from both measurements will be used to determine the intra cochlear electrode position then both data will be correlated.

Study Overview

Status

Unknown

Conditions

Cochlear Function Disorder

Intervention / Treatment

Device: NRT

Detailed Description

Cochlear implantation (CI) is a worldwide accepted and effective surgical procedure for patients with profound sensory neural hearing loss to gain near normal hearing.1 The position of electrode inside the cochlea affects the outcomes. Full insertion of the CI electrode array and insertion in scala tympani usually has optimal results and better words recognition.2 Translocation of electrode array from scala tympani to scala vestibule or outword migration of electrode array may result in poor response.2 There are many intraoperative and post operative techniques to determine the position of electrode array inside the cochlea, some are radiological as transorbital view plan x-ray or computed tomography or 3D rotational x ray and others are electrophysiological measurements.3 Although the accuracy of the radiological techinques they are time and cost consuming1. The electrically evoked cochlear action potential (ECAP) threshold is dependent on the distance between the electrodes and the spiral ganglion cells. The neural response telemetry-ratio (NRT-ratio) is one of the electrophysiological measurments techniques and it is based on each individual electrode's ECAP threshold and can identify the intracochlear electrode array position 4. According to a study done by Philipp Mittmann in 2015, a NRT-ratio above 1.05 indicates an electrode translocation from scala tympani to scala vestibuli and a NRT-ratio below 1.05 shows correlation to a pure scala tympani placement5, but another study found variation of the NRT-ratio in a group of patients with an electrode placement within scala tympani.6

Study Type

Observational

Enrollment (Anticipated)

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Egypt
- - Assiut, Egypt, Assiut university71515
    - Assiut University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 6 years (Child)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The study will be conducted as Prospective study at Otorhinolaryngology department, Assuit University Hospital .. All subjects will undergo implantation with Medel sonata flex 28 or standard electrodes with a standard surgical procedure. which will include extended end aural approach ,posterior tympanotomy and a round window insertion.The results of immediate postoperative NRT measurements & postoperative CT imaging will be obtained.

Each patient will be subjected to the following scheme:

immediate postoperative NRT measurements
postoperative CT imaging
Data obtained from both measurements will be used to determine the intra cochlear electrode position then both data will be correlated.

Description

Inclusion Criteria:

patients aged < 6years who will undergo cochlear implantation

Exclusion Criteria:

Revision cochlear implantation.
incomplete post-operative electrophysiological measurements.
unfit patients for surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Observational Models: Cohort
Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Value of Neural Response Telemetry (NRT) & Radiological measurments in evaluation of cochlear implant electrode positions Time Frame: Baseline	The study will be conducted as Prospective study including 50 patients (aged <6years ) at Otorhinolaryngology department, Assuit University Hospital (aged <6years ) who will undergo cochlear implantation. All subjects will undergo implantation with Medel sonata flex 28 or standard electrodes with a standard surgical procedure. The standard surgical procedure will include extended end aural approach ,posterior tympanotomy and a round window insertion.The results of immediate postoperative Neural Response Telemetry (NRT) measurements & postoperative CT imaging will be obtained. Each patient will be subjected to the following scheme: immediate postoperative Neural Response Telemetry (NRT) measurements postoperative CT imaging Data obtained from both measurements will be used to determine the intra cochlear electrode position then both data will be correlated.	Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

Study Director: Mohammed Abd El - Aziz, Prof

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

October 30, 2017

Primary Completion (Anticipated)

October 1, 2018

Study Completion (Anticipated)

November 1, 2018

Study Registration Dates

First Submitted

September 8, 2017

First Submitted That Met QC Criteria

October 9, 2017

First Posted (Actual)

October 10, 2017

Study Record Updates

Last Update Posted (Actual)