Assessment of the AB HiFocusTM Mid Scala Electrode Movement Using Cone Beam Imaging Following Cochlea Implantation (ABMS1)

One of the contributing factors to the variability in outcomes amongst Cochlear Implant (CI) recipients was reported to be the placement of the electrode array in the scala tympani. It seems that the correct placement of the electrode initially into the scala tympani and subsequent avoidance of dislocation into the scala vestibuli as the insertion progresses, is a key factor in achieving good speech perception outcomes. Another important aspect related to the performance is the achievement of consistent electrical coverage with the electrode. Data reported for electrodes of different manufacturers give depths ranging from 240 - 600 degrees showing the considerable variation across subjects. The HiFocus mid scala electrode was developed to cover one and a quarter turn and with the pre-curved design to be less susceptible to variations in individual cochlea dimensions and insertion techniques. A further mechanical feature of the pre-curved design is the avoidance of forces against the cochlear lateral wall and associated lower susceptibility of the electrode for moving out of the cochlea following insertion. Recently, a cone beam CT (CBCT) technique is being explored in the field of ENT with the potential to overcome some of the issues associated with the conventional CT techniques such as scattering, radiation and low isometric resolution. Images with comparable details to those of e.g. micro CTs are possible with much lower radiation dose. Modern imaging software i.e. 3D Slicer (www.slicer.org) may be used for 3D reconstruction, post processing and Brainsfit for registration. Registration is the alignment of two scans in the same coordinate system. This enables the identification of differences between two images recorded at time x and y. Once accurately superimposed any difference between the two images may be identified with an accuracy of 0.2 mm. Using these methods, one can assess the stability and the position of the electrode in the cochlea.

Objective: The primary objectives of this study are to evaluate the feasibility of using cone beam CT technique in combination with (high resolution) MRI to identify electrode movements following cochlear implant surgery and identify the inter-scalar position of the HFms electrode. The secondary objective is to quantify the average insertion depth and variations of the HFms electrode

Study Overview

• Status: Unknown
• Conditions: Cochlear Implantation; Cone-Beam Computed Tomography
• Intervention / Treatment: Radiation: Cone Beam Computed Tomography (CBCT); Device: Magnetic Resonance Imaging (MRI)

• Study Type: Interventional
• Enrollment (Anticipated): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Limburg
    • Maastricht, Limburg, Netherlands, 6202 AZ
      • Recruiting
      • Maastricht University Medical Center
      • Contact: Marc van Hoof, MD; Phone Number: +31433876543; Email: marc.hoofvan@mumc.nl
      • Contact: Guido Dees, MD MSc; Phone Number: +31433876543; Email: guido.dees@mumc.nl
      • Principal Investigator: Marc van Hoof, MD
      • Sub-Investigator: Guido Dees, MD MSc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Adults 18y or older meeting the conventional Dutch CI criteria
• The patient will receives the HiFocus Mid Scala electrode
• No cochlear or neural abnormalities that could compromise the placement of the electrode as assessed by the CI surgeon

Exclusion Criteria:

• Physical or non-physical contraindications for MRI or CT imaging
• No additional disabilities that may prevent active participation and testing as per protocol

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Intervention; All participants in the study will receive one pre-operative MRI, prior to cochlear implantation, and two cone-beam computed tomography scans, after cochlear implantation	Radiation: Cone Beam Computed Tomography (CBCT); Two postoperative CBCT scans, the first one on the day after cochlear implantation and the second after 3 months.; Device: Magnetic Resonance Imaging (MRI); One pre-operative (before cochlear implantation) MRI scan of the cochlea.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
movement of the electrode post-operatively in millimetres	3 months

Collaborators and Investigators

• Sponsor: Maastricht University Medical Center
• Collaborators: Advanced Bionics
• Investigators: Principal Investigator: Robert Stokroos, MD PhD, Maastricht University Medical Center

Study record dates

Study Major Dates

• Study Start: September 1, 2013
• Primary Completion (Anticipated): September 1, 2014
• Study Completion (Anticipated): September 1, 2014

Study Registration Dates

• First Submitted: September 9, 2013
• First Submitted That Met QC Criteria: September 11, 2013
• First Posted (Estimate): September 12, 2013

Study Record Updates

• Last Update Posted (Estimate): September 12, 2013
• Last Update Submitted That Met QC Criteria: September 11, 2013
• Last Verified: September 1, 2013

More Information

Terms related to this study

• Other Study ID Numbers: NL44381.068.13/METC 13-1-054