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| 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 |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Safety/Efficacy Study |
| Official Title: | Penetrating Auditory Brainstem Implant for Neurofibromatosis 2 |
| Estimated Enrollment: | 10 |
| Study Start Date: | September 2001 |
| Estimated Study Completion Date: | August 2003 |
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 |
Inclusion criteria:
Exclusion criteria:
Contacts and 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 | |
More Information
| Study ID Numbers: | FD-R-001969-01 |
| Study First Received: | January 30, 2002 |
| Last Updated: | January 31, 2006 |
| ClinicalTrials.gov Identifier: | NCT00030043 History of Changes |
| Health Authority: | United States: Federal Government |
|
Electric Stimulation Implants, Artificial Brainstem Electrodes Speech Perception |
|
Vestibulocochlear Nerve Diseases Otorhinolaryngologic Neoplasms Neuroma, Acoustic Retrocochlear Diseases Neurodegenerative Diseases Ear Diseases Neurofibromatosis 1 Neurofibromatosis 2 Deafness Heredodegenerative Disorders, Nervous System Neurofibromatosis Type 1 Neurofibroma Neuromuscular Diseases Neurofibromatosis Type 2 Neoplasms, Germ Cell and Embryonal |
Neuroepithelioma Hearing Loss Nervous System Neoplasms Neurocutaneous Syndromes Otorhinolaryngologic Diseases Neurilemmoma Neuroendocrine Tumors Neuroectodermal Tumors Neoplastic Syndromes, Hereditary Genetic Diseases, Inborn Peripheral Nervous System Diseases Neurofibromatoses Neuroma Nerve Sheath Neoplasms |
|
Vestibulocochlear Nerve Diseases Otorhinolaryngologic Neoplasms Neuroma, Acoustic Retrocochlear Diseases Neoplasms, Nerve Tissue Cranial Nerve Neoplasms Neurodegenerative Diseases Ear Diseases Neurofibromatosis 1 Neurofibromatosis 2 Heredodegenerative Disorders, Nervous System Neoplasms by Site Neurofibroma Neuromuscular Diseases Neoplasms, Germ Cell and Embryonal |
Nervous System Neoplasms Neurocutaneous Syndromes Otorhinolaryngologic Diseases Neoplasms by Histologic Type Nervous System Diseases Neurilemmoma Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms Neoplastic Syndromes, Hereditary Genetic Diseases, Inborn Peripheral Nervous System Diseases Neurofibromatoses Cranial Nerve Diseases Neuroma |
