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New treatment option for Hearing Loss, Bilateral (Causes Other Than Tumors)
Official title Auditory Brainstem Implant (ABI) in Children With No Cochleae or Auditory Nerves
ClinicalTrials.gov ID: NCT02310399
What this study is testing
- What it's testing
- This study is a feasibility study of the Nucleus 24 ABI in children without NF2. It will be conducted as a repeated-measures, single subject experiment in order to accommodate the known variability in cochlear implant clinical results.
- This is a blinded study.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 21
You may be able to join if
- Group 1: Prelinguistic hearing loss (birth-5 years; age at implantation of ABI 18 months-5 years)
- 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
You likely can't join if
- For both Groups 1 and 2:
- Pre- or post-linguistic child currently making significant progress with CI Even for the very young children (18 months of age with 6 months of use)...
- 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.
See the full eligibility criteria
- Group 1: Prelinguistic hearing loss (birth-5 years; age at implantation of ABI 18 months-5 years)
- 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.)
- 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 Group 2: Post-linguistic hearing loss (\<21 yrs. of age)
- Post-linguistic hearing loss (\<21 yrs. of age) with:
- 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.
- Strong family support
- Reasonable expectations from parents/guardians 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 a rehabilitation 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.
- Informed consent for the procedure from the child's parents/legal guardian.
- For both Groups 1 and 2:
- Pre- or post-linguistic child currently making significant progress with CI 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...
- 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
- Patients with evidence of Chiari malformation, hydrocephalus, spina bifid a
- Patients with any foreseeable need for a future MRI scan
- 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...
- 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 inherent to the procedure and ABI device.
- Unwilling to sign the informed consent.
- Unwilling to make necessary follow-up appointments.
The study team makes the final eligibility decision.
Where it's taking place
- New York, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 months to 21 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New York, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.