Feasibility Study of Auditory Brainstem Implant in Young Children

Phase 1

Withdrawn

• Conditions: Bilateral Cochlear Aplasia; Bilateral Cochlear Nerve Deficiency; Bilateral Cochlear Ossification Secondary to Meningitis
• Interventions: Device: Auditory brainstem implant

• Registration Number: NCT01850225
• Lead Sponsor: House Research Institute

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-04-24
• Study First Submitted QC: 2013-05-08
• Study First Posted: 2013-05-09
• Status Verified: 2013-10
• Study Start: 2013-10
• Last Update Submitted: 2015-03-17
• Last Update Posted: 2015-03-18
• Primary Completion: 2015-09
• Study Completion: 2017-09

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Device implantation	Auditory brainstem implant	Implantation of device

Primary Outcome Measures

Name	Time	Method
Number of Serious Adverse Events	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

Name	Time	Method
Access to sound at a level (dB) and within the frequency range (500-4000 Hz), known to be associated with speech	3 years post-activation	ability to detect sounds

Trial Locations

Locations (1)

House Research Institute CARE Center; 🇺🇸 Los Angeles, California, United States