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

This study has been completed.

Sponsored by: FDA Office of Orphan Products Development
Information provided by: FDA Office of Orphan Products Development
ClinicalTrials.gov Identifier: NCT00030043
  Purpose

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.


Condition Intervention Phase
Neurofibromatosis 2
Device: Penetrating auditory brainstem implant
Phase I

Genetics Home Reference related topics:   familial encephalopathy with neuroserpin inclusion bodies    neurofibromatosis type 2    nonsyndromic deafness   

MedlinePlus related topics:   Cancer    Neurofibromatosis   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Non-Randomized, Open Label, Uncontrolled, Safety/Efficacy Study
Official Title:   Penetrating Auditory Brainstem Implant for Neurofibromatosis 2

Further study details as provided by FDA Office of Orphan Products Development:

Estimated Enrollment:   10
Study Start Date:   September 2001
Estimated Study Completion Date:   August 2003

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.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00030043

Locations
United States, California
House Ear Institute    
      Los Angeles, California, United States, 90057
Huntington Medical Research Institutes    
      Pasadena, California, United States
United States, Colorado
Cochlear Corporation    
      Englewood, Colorado, United States

Sponsors and Collaborators
  More Information


Study ID Numbers:   FD-R-001969-01
First Received:   January 30, 2002
Last Updated:   January 31, 2006
ClinicalTrials.gov Identifier:   NCT00030043
Health Authority:   United States: Federal Government

Keywords provided by FDA Office of Orphan Products Development:
Electric Stimulation  
Implants, Artificial  
Brainstem  
Electrodes  
Speech Perception  

Study placed in the following topic categories:
Vestibulocochlear Nerve Diseases
Otorhinolaryngologic Neoplasms
Otorhinolaryngologic Diseases
Neuroma, Acoustic
Neurilemmoma
Neurodegenerative Diseases
Ear Diseases
Neurofibromatosis type 2
Neurofibromatosis 2
Neuroendocrine Tumors
Neuroectodermal Tumors
Deafness
Heredodegenerative Disorders, Nervous System
Neoplastic Syndromes, Hereditary
Genetic Diseases, Inborn
Neurofibroma
Neoplasms, Germ Cell and Embryonal
Neurofibromatoses
Neuroepithelioma
Hearing Loss
Neuroma
Nerve Sheath Neoplasms
Nervous System Neoplasms
Neurocutaneous Syndromes

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Nervous System Diseases
Retrocochlear Diseases
Neoplasms, Nerve Tissue
Cranial Nerve Neoplasms
Cranial Nerve Diseases

ClinicalTrials.gov processed this record on December 03, 2008




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