Auditory Brainstem Implantation in Young Children (NCT01904448) | Clinical Trial Compass
CompletedNot Applicable
Auditory Brainstem Implantation in Young Children
United States5 participantsStarted 2012-09
Plain-language summary
To purpose of this feasibility study is to demonstrate the safety and efficacy of the Nucleus 24 Multichannel Auditory Brainstem Implant (ABI, Cochlear Corp, Sydney, AUS) in children without the diagnosis of neurofibromatosis type II (NFII) that have either experienced failed cochlear implantation (CI) or have been unable to receive a CI secondary to cochlear or cochlear nerve disorders. These conditions can include: developmental or acquired cochlear nerve deficiency (CND), cochlear aplasia (Michel), post-meningitic cochlear ossification or cochlear malformation.
This study proposes to implant up to 10 young children (\<5 yrs. of age) with the Nucleus 24 Multichannel ABI (Sydney, AUS) in an attempt to demonstrate safety of the surgical procedure, tolerance of device stimulation, and the potential for auditory benefit beyond that experienced with their CI. This study will provide the preliminary experience for a larger scale clinical trial.
Aim 1: Demonstrate the safety of ABI surgery in children. Aim 2: Demonstrate the development of sound awareness and improved speech understanding among children implanted with the ABI when compared to their baseline skills. Aim 3: Demonstrate the development of oral language skills following the use of the ABI that were not evident prior to its use.
Who can participate
Age range18 Months – 17 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Pre-linguistic hearing loss (birth-5 yrs.; age at ABI 18 months-5yrs) with both:
* MRI +/- CT evidence of one of the following: Cochlear nerve deficiency, Cochlear aplasia or severe hypoplasia, Severe inner ear malformation, Post-meningitis ossification
* When a cochlea is present or patent, lack of significant benefit from CI despite consistent use (\>6 mo.)
* Post-linguistic hearing loss (\<18 yrs. of age) with both:
* Loss or lack of benefit from appropriate CI without the possibility for revision or contralateral implantation. Examples might include: Post-meningitis ossification, Bilateral temporal bone fractures with cochlear nerve avulsion, Failed revision CI without benefit
* Previously developed open set speech perception and auditory-oral language skills
* No medical contraindications
* Willing to receive the appropriate meningitis vaccinations
* No or limited cognitive/developmental delays which would be expected to interfere with the child's ability to cooperate in testing and/or programming of the device, in developing speech and oral language, or which would make an implant and subsequent emphasis on aural/oral communication not in the child's best interest
* Strong family support including language proficiency of the parent(s) in the child's primary mode of communication as well as written and spoken English.
* Reasonable expectations from parents including a thorough understanding:
* of potential benefits and limitations of ABI
* of …