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

NCT03306108 | Unknown

• 1 other identifier: NRT in Cochlear implantation
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Cochlear Function Disorder

Outcome Measures

Primary Outcomes (1)

• Value of Neural Response Telemetry (NRT) & Radiological measurments in evaluation of cochlear implant electrode positions

  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

Interventions

NRT DEVICE

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.

Eligibility Criteria

• Age: 2 Years - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut University Hospital

Asyut, Assiut University71515, Egypt

Location

Related Publications (3)

• Mittmann P, Todt I, Ernst A, Rademacher G, Mutze S, Goricke S, Schlamann M, Lang S, Arweiler-Harbeck D, Christov F. Radiological and NRT-Ratio-Based Estimation of Slim Straight Cochlear Implant Electrode Positions: A Multicenter Study. Ann Otol Rhinol Laryngol. 2017 Jan;126(1):73-78. doi: 10.1177/0003489416675355. Epub 2016 Oct 25.

  PMID: 27780910 BACKGROUND

• Mittmann P, Todt I, Ernst A, Rademacher G, Mutze S, Goricke S, Schlamann M, Ramalingam R, Lang S, Christov F, Arweiler-Harbeck D. Electrophysiological detection of scalar changing perimodiolar cochlear electrode arrays: a long term follow-up study. Eur Arch Otorhinolaryngol. 2016 Dec;273(12):4251-4256. doi: 10.1007/s00405-016-4175-2. Epub 2016 Jun 28.

  PMID: 27351885 BACKGROUND

• Lathuilliere M, Merklen F, Piron JP, Sicard M, Villemus F, Menjot de Champfleur N, Venail F, Uziel A, Mondain M. Cone-beam computed tomography in children with cochlear implants: The effect of electrode array position on ECAP. Int J Pediatr Otorhinolaryngol. 2017 Jan;92:27-31. doi: 10.1016/j.ijporl.2016.10.033. Epub 2016 Oct 31.

  PMID: 28012529 BACKGROUND

Study Officials

• Mohammed Abd El - Aziz, Prof

  STUDY DIRECTOR

Central Study Contacts

Samah Hamdy, residant

CONTACT

01067989166; Samahhamdy92@gmail.com

Muhammad Modather, Dr

CONTACT

01061577266; MuhammadModather@yahoo.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: September 8, 2017
• First Posted: October 10, 2017
• Study Start: October 30, 2017
• Primary Completion: October 1, 2018
• Study Completion: November 1, 2018
• Last Updated: October 10, 2017

Record last verified: 2017-09

Locations

EG (1)