Back to resultsAn 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
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
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
NCT ID
NCT00030043
First Posted
January 30, 2002
Last Updated
March 24, 2015
Sponsor
FDA Office of Orphan Products Development
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
Learn more about this trial
An Implant for Hearing Loss Due to Removal of Neurofibromatosis 2 Tumors
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