Feasibility Study of Auditory Brainstem Implant in Young Children
A Feasibility Study of the Placement, Use, and Safety of the Nucleus 24 Auditory Brainstem Implant in Non-Neurofibromatosis Type 2 (NF2) Pediatric Patients
1 other identifier
interventional
N/A
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Oct 2013
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 24, 2013
CompletedFirst Posted
Study publicly available on registry
May 9, 2013
CompletedStudy Start
First participant enrolled
October 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2017
CompletedMarch 18, 2015
October 1, 2013
1.9 years
April 24, 2013
March 17, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Number of Serious Adverse Events
Count of the number of expected serious adverse events must not exceed that known to occur in pediatric retrosigmoid craniotomy and Count of the number of unexpected serious adverse events must not exceed 2 in the first 5 children.
12-month post-activation
Secondary Outcomes (1)
Access to sound at a level (dB) and within the frequency range (500-4000 Hz), known to be associated with speech
3 years post-activation
Study Arms (1)
Device implantation
EXPERIMENTALImplantation of device
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Medical contraindication to craniotomy/intracranial surgery
- Severe cognitive or developmental delays
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- House Research Institutelead
- House Clinic, Inc.collaborator
- Children's Hospital Los Angelescollaborator
Study Sites (1)
House Research Institute CARE Center
Los Angeles, California, 90057, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Eric Wilkinson, MD
House Research Institute
- PRINCIPAL INVESTIGATOR
Laurie Eisenberg, PhD
House Research Institute
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 24, 2013
First Posted
May 9, 2013
Study Start
October 1, 2013
Primary Completion
September 1, 2015
Study Completion
September 1, 2017
Last Updated
March 18, 2015
Record last verified: 2013-10