An Implant for Hearing Loss Due to Removal of Neurofibromatosis 2 Tumors - Full Text View

Sponsor:	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 1

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Masking: Open Label Primary Purpose: Treatment
Official Title:	Penetrating Auditory Brainstem Implant for Neurofibromatosis 2

Resource links provided by NLM:

Genetics Home Reference related topics: neurofibromatosis type 2 nonsyndromic deafness Help Me Understand Genetics

MedlinePlus related topics: Cancer Neurofibromatosis

U.S. FDA Resources

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

FDA Office of Orphan Products Development

More Information

No publications provided

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

Keywords provided by FDA Office of Orphan Products Development:

Electric Stimulation
Implants, Artificial
Brainstem
Electrodes
Speech Perception

Additional relevant MeSH terms:

Neurofibromatosis 2
Neurofibromatoses
Neuroma, Acoustic
Neurilemmoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neurofibroma
Nerve Sheath Neoplasms
Neoplasms, Nerve Tissue
Neuroma
Nervous System Neoplasms

Neoplasms by Site
Neoplastic Syndromes, Hereditary
Vestibulocochlear Nerve Diseases
Retrocochlear Diseases
Ear Diseases
Otorhinolaryngologic Diseases
Otorhinolaryngologic Neoplasms
Cranial Nerve Neoplasms
Cranial Nerve Diseases
Nervous System Diseases
Neurocutaneous Syndromes
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn

ClinicalTrials.gov processed this record on May 21, 2012