Auditory Brainstem Implant (ABI) in Pediatric Non-Neurofibromatosis Type 2 Subjects

Stopped early · Not applicable

Conditions studied: Bilateral Hearing Loss for Causes Other Than Tumors

In brief

The purpose of this research study is to determine whether Auditory Brainstem Implant (ABI) can improve hearing in children who are deaf and cannot receive a cochlear implants.

Key facts

Study ID: NCT01864291
Run by: Massachusetts Eye and Ear Infirmary
People needed: 9
Starts: 2013-05-01
Expected to finish: 2019-04-25
Last updated by the study team: 2020-06-02

Who can join

Age: 2 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Pre-linguistic hearing loss (birth-5 yrs.; age at ABI implantation 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 with a normally appearing cochlear nerve, lack of significant benefit from CI despite consistent use (>6 mo.)
No or limited speech perception ability (limited to pattern perception on closed set testing materials using the CI)
Lack of progress in auditory skills development
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 parental role in rehabilitation
that the child may not develop spoken language as a primary communication mode or even sufficient spoken language to make significant academic progress in an aural/oral environment
Involvement in an educational program that emphasizes development of auditory skills with or without the use of supplementary visual communication.
Able to comply with study requirements including travel to investigation sites and clinic visits.

You may not qualify if…

Pre- or post-linguistic child currently making significant progress with CI - This will be considered if a child is progressing along the expected speech reception hierarchy (SRI-Q) as detailed by Wang et al (50). Even for the very young children (18 months of age with 6 months of use), nearly all children with a good auditory signal from their CI will have reached ceiling effects on the IT-MAIS and have pattern perception beyond chance using the ESP (50). Moreover, there will evidence of improvement in these metrics over time.
MRI evidence of one of the following:
normal cochlea and cochlear nerves or NF2
brainstem or cortical anomaly that makes implantation unfeasible
Clear surgical reason for poor CI performance that can be remediated with revision CI or contralateral surgery rather than ABI.
Intractable seizures or progressive, deteriorating neurological disorder
Unable to participate in behavioral testing and mapping with their CI. If this appears to be an age effect, ABI will be delayed until we can be assured that the child will be able to participate, as reliable objective measures of mapping are currently not available for mapping these devices.
Lack of potential for spoken language development. This will be considered the case when evidence of the following exist:
Severe psychomotor retardation, autism, cerebral palsy, or developmental delays beyond speech that would preclude usage of the device and oral educational development. Autism is a special case where there is the potential for delayed presentation. When early signs are considered present, we will request a comprehensive developmental assessment for further evaluation prior to considering routine evaluation.
Unable to tolerate general anesthesia (cardiac, pulmonary, bleeding diathesis, etc.).
Need for brainstem irradiation
Unrealistic expectations on the part of the subject/family regarding the possible benefits, risks and limitations that are inherent to the procedure and prosthetic device.
Unwilling to sign the informed consent.
Unwilling to make necessary follow-up appointments.

Where it is running

Massachusetts Eye and Ear Infirmary — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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