Back to resultsA Safety Study of the Auditory Brainstem Implant for Pediatric Profoundly Deaf Patients
Primary Purpose
Profound Bilateral Deafness Due to, Bilateral Cochlear Aplasia, Bilateral Cochlear Nerve Deficiency
Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Auditory Brainstem Implant
Sponsored by
About this trial
This is an interventional treatment trial for Profound Bilateral Deafness Due to focused on measuring deafness, congenital, pediatric, device
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
Sites / Locations
- Keck School of Medicine of USC
- Children's Hospital Los Angeles
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Experimental
Arm Description
Device Implantation
Outcomes
Primary Outcome Measures
Primary endpoint
Serious adverse event (count) per subject. Count of expected serious adverse events per subject.
Secondary Outcome Measures
Secondary endpoint: Preliminary efficacy
Access to sound at a level (dB) and with the frequency range (500-4000Hz), known to be associated with speech.
Unexpected Serious Adverse Events
Unexpected adverse events (count).
Full Information
NCT ID
NCT02102256
First Posted
March 19, 2014
Last Updated
February 13, 2019
Sponsor
Laurie Eisenberg
Collaborators
Keck School of Medicine of USC, Children's Hospital Los Angeles, Huntington Medical Research Institutes
1. Study Identification
Unique Protocol Identification Number
NCT02102256
Brief Title
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
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Unknown status
Study Start Date
March 2014 (undefined)
Primary Completion Date
January 2019 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Laurie Eisenberg
Collaborators
Keck School of Medicine of USC, Children's Hospital Los Angeles, Huntington Medical Research Institutes
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Profound Bilateral Deafness Due to, Bilateral Cochlear Aplasia, Bilateral Cochlear Nerve Deficiency, Bilateral Cochlear Ossification Secondary to Meningitis
Keywords
deafness, congenital, pediatric, device
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental
Arm Type
Experimental
Arm Description
Device Implantation
Intervention Type
Device
Intervention Name(s)
Auditory Brainstem Implant
Other Intervention Name(s)
Cochlear Corporation Nucleus 24
Primary Outcome Measure Information:
Title
Primary endpoint
Description
Serious adverse event (count) per subject. Count of expected serious adverse events per subject.
Time Frame
12-months post-device activation
Secondary Outcome Measure Information:
Title
Secondary endpoint: Preliminary efficacy
Description
Access to sound at a level (dB) and with the frequency range (500-4000Hz), known to be associated with speech.
Time Frame
3 years post-device activation
Title
Unexpected Serious Adverse Events
Description
Unexpected adverse events (count).
Time Frame
12-months post-activation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laurie S. Eisenberg, PhD
Organizational Affiliation
Keck School of Medicine of USC
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Eric Wilkinson, MD
Organizational Affiliation
Huntington Medical Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Keck School of Medicine of USC
City
Los Angeles
State/Province
California
ZIP/Postal Code
90008
Country
United States
Facility Name
Children's Hospital Los Angeles
City
Los Angeles
State/Province
California
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
29718280
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.
Results Reference
derived
PubMed Identifier
27898605
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.
Results Reference
derived
Learn more about this trial
A Safety Study of the Auditory Brainstem Implant for Pediatric Profoundly Deaf Patients
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