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Feasibility Study of Auditory Brainstem Implant in Young Children

This study has been withdrawn prior to enrollment.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01850225
First Posted: May 9, 2013
Last Update Posted: March 18, 2015
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.
Collaborators:
House Clinic, Inc.
Children's Hospital Los Angeles
Information provided by (Responsible Party):
House Research Institute
  Purpose
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 Intervention Phase
Bilateral Cochlear Aplasia Bilateral Cochlear Nerve Deficiency Bilateral Cochlear Ossification Secondary to Meningitis Device: Auditory brainstem implant Phase 1

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by House Research Institute:

Primary Outcome Measures:
  • Number of Serious Adverse Events [ Time Frame: 12-month post-activation ]
    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.


Secondary Outcome Measures:
  • Access to sound at a level (dB) and within the frequency range (500-4000 Hz), known to be associated with speech [ Time Frame: 3 years post-activation ]
    ability to detect sounds


Enrollment: 0
Study Start Date: October 2013
Estimated Study Completion Date: September 2017
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Device implantation
Implantation of device
Device: Auditory brainstem implant
Other Name: Cochlear Corporation Nucleus 24

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 5 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
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): NCT01850225


Locations
United States, California
House Research Institute CARE Center
Los Angeles, California, United States, 90057
Sponsors and Collaborators
House Research Institute
House Clinic, Inc.
Children's Hospital Los Angeles
Investigators
Principal Investigator: Eric Wilkinson, MD House Research Institute
Principal Investigator: Laurie Eisenberg, PhD House Research Institute
  More Information

Responsible Party: House Research Institute
ClinicalTrials.gov Identifier: NCT01850225     History of Changes
Other Study ID Numbers: Ped ABI
First Submitted: April 24, 2013
First Posted: May 9, 2013
Last Update Posted: March 18, 2015
Last Verified: October 2013

Additional relevant MeSH terms:
Meningitis
Central Nervous System Diseases
Nervous System Diseases