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Cochlear Function DisorderNCT03306108

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

An observational study of Cochlear Function Disorder, run by Assiut University at 1 site in Egypt.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 2 to 6 yearsHealthy volunteers can take part
Conditions the study is for
Cochlear Function Disorder
What is being tested?
NRT
Type of treatment
Medical device
How many people
50 participants
Where
1 siteEgypt
Study dates
30 Oct 2017to Nov 2018
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 2 to 6 years
  • All sexes
  • Healthy volunteers accepted
  • Child

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.

Who may be able to join

  • patients aged < 6years who will undergo cochlear implantation

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Samah Hamdy, residant contact

01067989166

Samahhamdy92@gmail.com

Muhammad Modather, Dr contact

01061577266

MuhammadModather@yahoo.com

Egypt1 site

  • Assiut University Hospital

    Asyut, Assiut University71515

Other trials in Egypt

About this study

Official title: 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.
Read the 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

Being tested
NRT

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NRTDevice

    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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Oct 2017
  2. Study start30 Oct 2017 (estimated)
  3. Primary completionOct 2018 (estimated)
  4. Study completionNov 2018 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03306108
Sponsor's protocol ID
NRT in Cochlear implantation
Status last verified
Sep 2017
First submitted
8 Sep 2017
Last updated
10 Oct 2017
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 27780910

  • 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.

    PubMed 27351885

  • 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.

    PubMed 28012529

Questions about this trial

What is this clinical trial studying?

An observational study of Cochlear Function Disorder, run by Assiut University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 10 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Samah Hamdy, residant (01067989166, Samahhamdy92@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Value of Neural Response Telemetry (NRT) & Radiological measurments in evaluation of cochlear implant electrode positions (time frame: Baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03306108, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2017.

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