Cochlear Implantation Clinical Trial
— ABMS1Official title:
Assessment of the AB HiFocusTM Mid Scala Electrode Movement Using Cone Beam Imaging Following Cochlea Implantation
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
Status | Recruiting |
Enrollment | 14 |
Est. completion date | September 2014 |
Est. primary completion date | September 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Country | Name | City | State |
---|---|---|---|
Netherlands | Maastricht University Medical Center | Maastricht | Limburg |
Lead Sponsor | Collaborator |
---|---|
Maastricht University Medical Center | Advanced Bionics |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | movement of the electrode post-operatively in millimetres | 3 months | No |
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