Auditory Brainstem Implantation in Young Children
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.
Developmental Cochlear Nerve Deficiency
Acquired Cochlear Nerve Deficiency
Post-meningitis Cochlear Ossification
Device: Auditory Brainstem Implantation in Children
|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|
- 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.
- 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
- 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.
|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)|
Experimental: Auditory Brainstem Implant
single-arm study of auditory brainstem implantation in children
|Device: Auditory Brainstem Implantation in Children|
|Contact: Craig A Buchman, MD||919 firstname.lastname@example.org|
|Contact: Holly FB Teagle, AuD||919 email@example.com|
|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 firstname.lastname@example.org|
|Contact: Holly FB Teagle, AuD 919 419-1449 email@example.com|
|Principal Investigator: Craig A Buchman, MD|
|Principal Investigator:||Craig A Buchman, MD||University of North Carolina, Chapel Hill|