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

• Conditions: Cochlear Function Disorder

• Registration Number: NCT03306108
• Lead Sponsor: Assiut University

Brief Summary

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.

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 Timeline

• Status Verified: 2017-09
• Study First Submitted: 2017-09-08
• Study First Submitted QC: 2017-10-09
• Last Update Submitted: 2017-10-09
• Study First Posted: 2017-10-10
• Last Update Posted: 2017-10-10
• Study Start: 2017-10-30
• Primary Completion: 2018-10
• Study Completion: 2018-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• patients aged < 6years who will undergo cochlear implantation

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Value of Neural Response Telemetry (NRT) & Radiological measurments in evaluation of cochlear implant electrode positions	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.

Trial Locations

Locations (1)

Assiut University Hospital; 🇪🇬 Assiut, Egypt