Auditory Brainstem Implantation in Young Children

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by University of North Carolina, Chapel Hill
Sponsor:
Information provided by (Responsible Party):
Craig A. Buchman, MD, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT01904448
First received: July 3, 2013
Last updated: April 5, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Developmental Cochlear Nerve Deficiency
Acquired Cochlear Nerve Deficiency
Cochlear Aplasia
Post-meningitis Cochlear Ossification
Cochlear Malformation
Device: Auditory Brainstem Implantation in Children
Phase 0

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Early Feasibility Study of the Safety and Efficacy of the Nucleus 24 Auditory Brainstem Implant in Children With Cochlear or Cochlear Nerve Disorders Not Resulting From Neurofibromatosis Type II

Resource links provided by NLM:


Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • Safety and Complications [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    Complications and related outcomes will be tracked and recorded. These include bleeding, infection, neural injury, cerebrospinal fluid leakage, brain bleeding or bruising, stroke, death. Also, complications and sequelae related to the device such as non-auditory stimulation and device failure will be tracked.


Secondary Outcome Measures:
  • Speech Perception [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    • Detection audiogram, aided and unaided individual ears
    • IT-MAIS or MAIS
    • LING 6 sound test
    • ESP Low Verbal or Standard- MLV @ 50dB HL
    • PB-k words and phonemes- MLV @ 50dB HL
    • MLNT- recorded @ 60dB SPL, If >50% then
    • LNT- recorded @ 60dB SPL, If >80%, then
    • CNC- 50 words @ 60dB SPL
    • HINT-C- 2 lists of 10 @ 60dB SPL


Other Outcome Measures:
  • Speech Production and Language [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    MacArthur-Bates Communicative Development Inventories (CDIs) Pre-School Language Scale, Fourth Edition (PLS-5) The Oral and Written Language Scales (OWLS) Goldman-Fristoe Test of Articulation.


Estimated Enrollment: 10
Study Start Date: September 2012
Estimated Study Completion Date: April 2023
Estimated Primary Completion Date: April 2023 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Auditory Brainstem Implant
single-arm study of auditory brainstem implantation in children
Device: Auditory Brainstem Implantation in Children

  Eligibility

Ages Eligible for Study:   18 Months to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 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.
  • Informed consent for the procedure from the child's parents/legal guardian.

Exclusion Criteria:

  • Pre- or post-linguistic child currently making significant progress with CI
  • MRI evidence of one of the following:

    • normal cochlea and cochlear nerves or NFII
    • 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, our group routinely requests a comprehensive developmental assessment for further evaluation prior to considering routine evaluation. A specialized group is readily available at our institution for such an 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01904448

Contacts
Contact: Craig A Buchman, MD 919 966-6484 buchman@med.unc.edu
Contact: Holly FB Teagle, AuD 919 419-1449 holly_teagle@med.unc.edu

Locations
United States, North Carolina
University of North Carolina at Chapel Hill Recruiting
Chapel Hill, North Carolina, United States, 27599-7600
Contact: Craig A Buchman, MD    919-966-6484    buchman@med.unc.edu   
Contact: Holly FB Teagle, AuD    919 419-1449    holly_teagle@med.unc.edu   
Principal Investigator: Craig A Buchman, MD         
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Investigators
Principal Investigator: Craig A Buchman, MD University of North Carolina, Chapel Hill
  More Information

No publications provided

Responsible Party: Craig A. Buchman, MD, Professor and Vice Chair for Clinical Affairs, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT01904448     History of Changes
Other Study ID Numbers: 12-0664, IDE# G120019/S001
Study First Received: July 3, 2013
Last Updated: April 5, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by University of North Carolina, Chapel Hill:
pediatric
profound hearing loss
auditory brainstem implant
cochlear implant
developmental or acquired cochlear nerve deficiency (CND)
cochlear aplasia (Michel)
post-meningitis cochlear ossification
cochlear malformation
CND

Additional relevant MeSH terms:
Meningitis
Congenital Abnormalities
Central Nervous System Infections
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on September 18, 2014