RECRUITING

Auditory Brainstem Implant (ABI) in Children With No Cochleae or Auditory Nerves

Conditions

Hearing Loss, Bilateral (Causes Other Than Tumors)Auditory Brainstem Implant Deafness Hearing Loss ABI

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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. Data obtained in the course of this study will be compared with the existing published outcome data from children with normal hearing and with cochlear implants (CIs). These comparisons may provide additional useful information about the progress of ABI subjects' performance over time. Also, this may allow the results of the current study to be utilized to design future pivotal studies of the device in the pediatric population.

Official Title

Auditory Brainstem Implant (ABI) in Children With No Cochleae or Auditory Nerves

Quick Facts

Study Start:2014-05

Study Completion:2027-05-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT02310399

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Months to 21 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT

Inclusion Criteria	Exclusion Criteria
* 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 * 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.	* 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 show 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 * 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 measures of mapping are currently not available for mapping these devices. * 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.

Inclusion Criteria

Exclusion Criteria

* 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
* 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.

* 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 show 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
* 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 measures of mapping are currently not available for mapping these devices.
* 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.

Contacts and Locations

Study Contact

Susan B Waltzman, PhD

CONTACT

212-263-8803

susan.waltzman@nyumc.org

Kristin Montella

CONTACT

2122638182

km302@nyumc.org

Principal Investigator

John T. Roland, Jr., MD

PRINCIPAL_INVESTIGATOR

NYU Langone Health

Study Locations (Sites)

NYU Cochlear Implant Center

New York, New York, 10016

United States

Collaborators and Investigators

Sponsor: NYU Langone Health

John T. Roland, Jr., MD, PRINCIPAL_INVESTIGATOR, NYU Langone Health

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2014-05

Study Completion Date2027-05-01

Study Record Updates

Study Start Date2014-05

Study Completion Date2027-05-01

Terms related to this study

Keywords Provided by Researchers

Auditory Brainstem Implant
Deafness
Hearing Loss
ABI

Additional Relevant MeSH Terms

Hearing Loss, Bilateral (Causes Other Than Tumors)