Auditory Brainstem Implant (ABI) in Pediatric Non-Neurofibromatosis Type 2 Subjects (NCT01864291) | Clinical Trial Compass
TerminatedNot Applicable
Auditory Brainstem Implant (ABI) in Pediatric Non-Neurofibromatosis Type 2 Subjects
Stopped: Closed by IRB
United States9 participantsStarted 2013-05
Plain-language summary
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.
Who can participate
Age range18 Months – 17 Years
SexALL
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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 implantation 18 months-5yrs) with both:
✓. MRI +/- CT evidence of one of the following:
✓. When a cochlea is present or patent with a normally appearing cochlear nerve, 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:
✓. Previously developed open set speech perception and auditory-oral language skills
✓. No medical contraindications
✓. Willing to receive the appropriate meningitis vaccinations
Exclusion criteria
✕. 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:
✕
What they're measuring
1
Number of Participants With Major or Minor ABI Complications
. 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:
✕. Unable to tolerate general anesthesia (cardiac, pulmonary, bleeding diathesis, etc.).