Feasibility Study of Auditory Brainstem Implant in Young Children

Bilateral Cochlear Aplasia Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01850225
• Other study ID #: Ped ABI
• Status: Withdrawn
• Phase: Phase 1
• First received: April 24, 2013
• Last updated: March 17, 2015
• Start date: October 2013
• Est. completion date: September 2017

Study information

• Verified date: October 2013
• Source: House Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2017
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 5 Years

Eligibility

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 Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bilateral Cochlear Aplasia
• Bilateral Cochlear Nerve Deficiency
• Bilateral Cochlear Ossification Secondary to Meningitis

Intervention

Device:
• Auditory brainstem implant

Locations

Country	Name	City	State
United States	House Research Institute CARE Center	Los Angeles	California

Sponsors (3)

Lead Sponsor	Collaborator
House Research Institute	Children's Hospital Los Angeles, House Clinic, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Serious Adverse Events	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.	12-month post-activation	Yes
Secondary	Access to sound at a level (dB) and within the frequency range (500-4000 Hz), known to be associated with speech	ability to detect sounds	3 years post-activation	No