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

February 13, 2019 updated by: Laurie Eisenberg

A Feasibility Study of the Placement, Use, and Safety of the Nucleus 24 Auditory Brainstem Implant in Non-Neurofibromatosis Type 2 (NF2) Pediatric Patients

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

10

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States
        • Children's Hospital Los Angeles
      • Los Angeles, California, United States, 90008
        • Keck School of Medicine of USC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 6 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental
Device Implantation
Device: Auditory Brainstem Implant
Other Names:
  • Cochlear Corporation Nucleus 24

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 years post-device activation
Unexpected Serious Adverse Events
Time Frame: 12-months post-activation
Unexpected adverse events (count).
12-months post-activation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Laurie Eisenberg

Collaborators

Children's Hospital Los Angeles
Huntington Medical Research Institutes
Keck School of Medicine of USC

Investigators

  • Principal Investigator: Laurie S. Eisenberg, PhD, Keck School of Medicine of USC
  • Principal Investigator: Eric Wilkinson, MD, Huntington Medical Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2014

Primary Completion (Actual)

January 1, 2019

Study Registration Dates

First Submitted

March 19, 2014

First Submitted That Met QC Criteria

March 28, 2014

First Posted (Estimate)

April 2, 2014

Study Record Updates

Last Update Posted (Actual)

February 15, 2019

Last Update Submitted That Met QC Criteria

February 13, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KSOM-ABI 001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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