search
Back to results

Feasibility Study of Auditory Brainstem Implant in Young Children

Primary Purpose

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

Status
Withdrawn
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Auditory brainstem implant
Sponsored by
House Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bilateral Cochlear Aplasia

Eligibility Criteria

2 Years - 5 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • House Research Institute CARE Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Device implantation

Arm Description

Implantation of device

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
April 24, 2013
Last Updated
March 17, 2015
Sponsor
House Research Institute
Collaborators
House Clinic, Inc., Children's Hospital Los Angeles
search

1. Study Identification

Unique Protocol Identification Number
NCT01850225
Brief Title
Feasibility Study of Auditory Brainstem Implant in Young Children
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2013
Overall Recruitment Status
Withdrawn
Study Start Date
October 2013 (undefined)
Primary Completion Date
September 2015 (Anticipated)
Study Completion Date
September 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
House Research Institute
Collaborators
House Clinic, Inc., Children's Hospital Los Angeles

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bilateral Cochlear Aplasia, Bilateral Cochlear Nerve Deficiency, Bilateral Cochlear Ossification Secondary to Meningitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Device implantation
Arm Type
Experimental
Arm Description
Implantation of device
Intervention Type
Device
Intervention Name(s)
Auditory brainstem implant
Other Intervention Name(s)
Cochlear Corporation Nucleus 24
Primary Outcome Measure Information:
Title
Number of Serious Adverse Events
Description
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.
Time Frame
12-month post-activation
Secondary Outcome Measure Information:
Title
Access to sound at a level (dB) and within the frequency range (500-4000 Hz), known to be associated with speech
Description
ability to detect sounds
Time Frame
3 years post-activation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric Wilkinson, MD
Organizational Affiliation
House Research Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Laurie Eisenberg, PhD
Organizational Affiliation
House Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
House Research Institute CARE Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90057
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Feasibility Study of Auditory Brainstem Implant in Young Children

We'll reach out to this number within 24 hrs