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

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: Active, not recruiting

Administrative data

• NCT number: NCT02102256
• Other study ID #: KSOM-ABI 001
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: March 2014

Study information

• Verified date: February 2019
• Source: University of Southern California
• Contact: n/a
• Is FDA regulated: No
• 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: Active, not recruiting
• Enrollment: 10
• Est. primary completion date: January 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 6 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

Related Conditions & MeSH terms

• Bilateral Cochlear Aplasia
• Bilateral Cochlear Nerve Deficiency
• Bilateral Cochlear Ossification Secondary to Meningitis
• Deafness
• Hearing Loss
• Meningitis
• Profound Bilateral Deafness Due to

Intervention

Device:
• Auditory Brainstem Implant

Locations

Country	Name	City	State
United States	Children's Hospital Los Angeles	Los Angeles	California
United States	Keck School of Medicine of USC	Los Angeles	California

Sponsors (4)

Lead Sponsor	Collaborator
Laurie Eisenberg	Children's Hospital Los Angeles, Huntington Medical Research Institutes, Keck School of Medicine of USC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary endpoint	Serious adverse event (count) per subject. Count of expected serious adverse events per subject.	12-months post-device activation
Secondary	Secondary endpoint: Preliminary efficacy	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
Secondary	Unexpected Serious Adverse Events	Unexpected adverse events (count).	12-months post-activation