Clinical trial NCT02102256: A Safety Study of the Auditory Brainstem Implant for Pediatric Profoundly Deaf Patients
Official title: A Feasibility Study of the Placement, Use, and Safety of the Nucleus 24 Auditory Brainstem Implant in Non-Neurofibromatosis Type 2 (NF2) Pediatric Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Profound Bilateral Deafness Due to
Bilateral Cochlear Aplasia
Bilateral Cochlear Nerve Deficiency
Bilateral Cochlear Ossification Secondary to Meningitis
Keywords: deafness
congenital
pediatric
device
Lead sponsor: University of Southern California
Sponsor class: OTHER
Collaborators: name: Keck School of Medicine of USC
name: Children's Hospital Los Angeles
name: Huntington Medical Research Institutes
First posted: 2014-04-02
Enrollment: 10
Sex: ALL
Minimum age (years): 2
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Current treatment options for bilateral profoundly deaf children, diagnosed with inner ear anatomical abnormalities, are limited and, in the case of absent cochleas, non-existent. An auditory brainstem implant (ABI) places an electrode close to the auditory nucleus in the brainstem. Children aged 2 - 5 who are not candidates for a cochlear implant, or who did not demonstrate benefit from a cochlear implant, will be implanted with an ABI and followed for 1 year for safety and a total of 3 years for preliminary efficacy. This is a feasibility study to determine the safety of the ABI.


Eligibility criteria: Inclusion Criteria:

* Bilateral profound deafness due to cochlear aplasia, cochlear nerve deficiency, or ossification secondary to meningitis
* If previously received a cochlear implant, must demonstrate lack of benefit from that device

Exclusion Criteria:

* Medical contraindication to craniotomy/intracranial surgery
* Severe cognitive or developmental delays

Primary outcomes:
measure: Primary endpoint
timeFrame: 12-months post-device activation
Secondary outcomes:
measure: Secondary endpoint: Preliminary efficacy
timeFrame: 3 years post-device activation
measure: Unexpected Serious Adverse Events
timeFrame: 12-months post-activation
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Keck School of Medicine of USC
state: California
city: Los Angeles
country: United States
facility: Children's Hospital Los Angeles
state: California
Study officials:
affiliation: Keck School of Medicine of USC
name: Laurie S. Eisenberg, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Huntington Medical Research Institute
name: Eric Wilkinson, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Eisenberg LS, Hammes Ganguly D, Martinez AS, Fisher LM, Winter ME, Glater JL, Schrader DK, Loggins J, Wilkinson EP; Los Angeles Pediatric ABI Team. Early Communication Development of Children with Auditory Brainstem Implants. J Deaf Stud Deaf Educ. 2018 Jul 1;23(3):249-260. doi: 10.1093/deafed/eny010.
citation: Wilkinson EP, Eisenberg LS, Krieger MD, Schwartz MS, Winter M, Glater JL, Martinez AS, Fisher LM, Shannon RV; Los Angeles Pediatric ABI Team. Initial Results of a Safety and Feasibility Study of Auditory Brainstem Implantation in Congenitally Deaf Children. Otol Neurotol. 2017 Feb;38(2):212-220. doi: 10.1097/MAO.0000000000001287.