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An Implant for Hearing Loss Due to Removal of Neurofibromatosis 2 Tumors

Primary Purpose

Neurofibromatosis 2

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Penetrating auditory brainstem implant
Sponsored by
FDA Office of Orphan Products Development
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neurofibromatosis 2 focused on measuring Electric Stimulation, Implants, Artificial, Brainstem, Electrodes, Speech Perception

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria: Diagnosis of neurofibromatosis type 2 Speak English as a primary language Exclusion criteria: Physical, psychological, or medical conditions that contraindicate the surgical procedure

Sites / Locations

  • House Ear Institute
  • Huntington Medical Research Institutes
  • Cochlear Corporation

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
January 30, 2002
Last Updated
March 24, 2015
Sponsor
FDA Office of Orphan Products Development
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1. Study Identification

Unique Protocol Identification Number
NCT00030043
Brief Title
An Implant for Hearing Loss Due to Removal of Neurofibromatosis 2 Tumors
Official Title
Penetrating Auditory Brainstem Implant for Neurofibromatosis 2
Study Type
Interventional

2. Study Status

Record Verification Date
January 2002
Overall Recruitment Status
Completed
Study Start Date
September 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2003 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
FDA Office of Orphan Products Development

4. Oversight

5. Study Description

Brief Summary
This is a study to gather some information on the safety and efficacy of the penetrating auditory brainstem implant (PABI) in patients with neurofibromatosis type 2.
Detailed Description
Neurofibromatosis Type 2 (NF2) is characterized by multiple tumors of the cranial and spinal nerves, and, in particular, by bilateral acoustic tumors. Surgical resection of these tumors generally results in the transection of the VIIIth nerve, destruction of the cochlea and auditory nerve, and total hearing loss. Due to the loss of the auditory nerve, these patients are not candidates for cochlear implantation. The Auditory Brainstem Implant (ABI) provides the only available intervention to restore some auditory sensation to these patients. An ABI is an implantable prosthesis that produces sound sensation by electrical stimulation of the ascending auditory pathway at the level of the cochlear nucleus. The PABI may be placed surgically during tumor resection. Efficacy will be assessed using psychophysical and standard speech reception measures.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neurofibromatosis 2
Keywords
Electric Stimulation, Implants, Artificial, Brainstem, Electrodes, Speech Perception

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10 (false)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
Penetrating auditory brainstem implant

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: Diagnosis of neurofibromatosis type 2 Speak English as a primary language Exclusion criteria: Physical, psychological, or medical conditions that contraindicate the surgical procedure
Facility Information:
Facility Name
House Ear Institute
City
Los Angeles
State/Province
California
ZIP/Postal Code
90057
Country
United States
Facility Name
Huntington Medical Research Institutes
City
Pasadena
State/Province
California
Country
United States
Facility Name
Cochlear Corporation
City
Englewood
State/Province
Colorado
Country
United States

12. IPD Sharing Statement

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An Implant for Hearing Loss Due to Removal of Neurofibromatosis 2 Tumors

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