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A Safety Study of the Auditory Brainstem Implant for Pediatric Profoundly Deaf Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02102256
Recruitment Status : Unknown
Verified February 2019 by Laurie Eisenberg, University of Southern California.
Recruitment status was:  Active, not recruiting
First Posted : April 2, 2014
Last Update Posted : February 15, 2019
Sponsor:
Collaborators:
Keck School of Medicine of USC
Children's Hospital Los Angeles
Huntington Medical Research Institutes
Information provided by (Responsible Party):
Laurie Eisenberg, University of Southern California

Study Description
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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.

Condition or disease Intervention/treatment Phase
Profound Bilateral Deafness Due to Bilateral Cochlear Aplasia Bilateral Cochlear Nerve Deficiency Bilateral Cochlear Ossification Secondary to Meningitis Device: Auditory Brainstem Implant Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : March 2014
Actual Primary Completion Date : January 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Experimental
Device Implantation
 Device: Auditory Brainstem Implant
Other Name: Cochlear Corporation Nucleus 24


Outcome Measures
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Primary Outcome Measures :
  1. Primary endpoint [ Time Frame: 12-months post-device activation ]
    Serious adverse event (count) per subject. Count of expected serious adverse events per subject.


Secondary Outcome Measures :
  1. Secondary endpoint: Preliminary efficacy [ Time Frame: 3 years post-device activation ]
    Access to sound at a level (dB) and with the frequency range (500-4000Hz), known to be associated with speech.

  2. Unexpected Serious Adverse Events [ Time Frame: 12-months post-activation ]
    Unexpected adverse events (count).


Eligibility Criteria
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Ages Eligible for Study:   2 Years to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

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): NCT02102256


Locations
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United States, California
Keck School of Medicine of USC
Los Angeles, California, United States, 90008
Children's Hospital Los Angeles
Los Angeles, California, United States
Sponsors and Collaborators
Laurie Eisenberg
Keck School of Medicine of USC
Children's Hospital Los Angeles
Huntington Medical Research Institutes
Investigators
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Principal Investigator: Laurie S. Eisenberg, PhD Keck School of Medicine of USC
Principal Investigator: Eric Wilkinson, MD Huntington Medical Research Institute
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Laurie Eisenberg, Professor of Research Otolaryngology, University of Southern California
ClinicalTrials.gov Identifier: NCT02102256    
Other Study ID Numbers: KSOM-ABI 001
First Posted: April 2, 2014    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019
Keywords provided by Laurie Eisenberg, University of Southern California:
deafness
congenital
pediatric
device
Additional relevant MeSH terms:
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Deafness
Hearing Loss
Hearing Loss, Bilateral
Meningitis
Central Nervous System Diseases
Nervous System Diseases
 Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations