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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03306108
Enrollment
50
Registered
2017-10-10
Start date
2017-10-30
Completion date
2018-11-30
Last updated
2017-10-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cochlear Function Disorder

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

Interventions

DEVICENRT

NRTratio is based on each individual electrode's ECAP threshold and can identify the intracochlear electrode array position in perimodiolar electrodes. The NRT-ratio showed a good reliability for the determination of the intracochlear electrode array position compared to the radiologic control intraoperatively Calculation of the NRT-ratio is done by dividing the arithmetic average of the t-NRT values from the apical electrodes 16 to 18 divided by the arithmetic average of the basal t-NRT from electrodes 5 to 7. With a NRT-ratio above 1.05, a high chance of a scalar change was rather likely, and a NRT-ratio below 1.05 was associated with a high chance of an electrode array position within the scala tympani.

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
2 Years to 6 Years
Healthy volunteers
Yes

Inclusion criteria

* patients aged \< 6years who will undergo cochlear implantation

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Value of Neural Response Telemetry (NRT) & Radiological measurments in evaluation of cochlear implant electrode positionsBaselineThe 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.

Countries

Egypt

Contacts

Primary ContactSamah Hamdy, residant
Samahhamdy92@gmail.com01067989166
Backup ContactMuhammad Modather, Dr
MuhammadModather@yahoo.com01061577266

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026