Auditory Brainstem Implantation in Young Children
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|ClinicalTrials.gov Identifier: NCT01904448|
Recruitment Status : Suspended (Primary surgeon has left UNC)
First Posted : July 22, 2013
Last Update Posted : April 20, 2017
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 or disease||Intervention/treatment||Phase|
|Developmental Cochlear Nerve Deficiency Acquired Cochlear Nerve Deficiency Cochlear Aplasia Post-meningitis Cochlear Ossification Cochlear Malformation||Device: Auditory Brainstem Implantation in Children||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||5 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Device Feasibility|
|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|
|Study Start Date :||September 2012|
|Estimated Primary Completion Date :||October 2017|
|Estimated Study Completion Date :||December 2017|
Experimental: Auditory Brainstem Implant
single-arm study of auditory brainstem implantation in children
|Device: Auditory Brainstem Implantation in Children|
- Safety and Complications [ Time Frame: 3 years ]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 ]
- 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 ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01904448
|United States, North Carolina|
|University of North Carolina at Chapel Hill|
|Chapel Hill, North Carolina, United States, 27599-7600|
|Study Chair:||Craig A Buchman, MD||University of North Carolina, Chapel Hill|