Feasibility Study of Auditory Brainstem Implant in Young Children

This study has been withdrawn prior to enrollment.
Sponsor:
Collaborators:
House Clinic
Children's Hospital Los Angeles
Information provided by (Responsible Party):
House Research Institute
ClinicalTrials.gov Identifier:
NCT01850225
First received: April 24, 2013
Last updated: April 10, 2014
Last verified: October 2013
  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: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    ability to detect sounds


Estimated Enrollment: 10
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

Ages Eligible for Study:   2 Years to 5 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01850225

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

No publications provided

Responsible Party: House Research Institute
ClinicalTrials.gov Identifier: NCT01850225     History of Changes
Other Study ID Numbers: Ped ABI
Study First Received: April 24, 2013
Last Updated: April 10, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on April 16, 2014