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

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

FDA Office of Orphan Products Development

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

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