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| Sponsors and Collaborators: |
FDA Office of Orphan Products Development Cochlear |
|---|---|
| Information provided by: | FDA Office of Orphan Products Development |
| ClinicalTrials.gov Identifier: | NCT00004437 |
Purpose
OBJECTIVES: I. Define the tonotopocity of multichannel brain stem stimulation and use this information to better program the auditory brain stem implant for an individual. II. Optimize device fitting by combining monopolar and bipolar stimulation, and individual psychoacoustic channels for each patient, to increase the number of usable information channels for each patient and reduce or eliminate undesirable side effects.
III. Evaluate performance and learning effects using optimized fitting procedures.
| Condition | Intervention | Phase |
|---|---|---|
|
Neurofibromatosis 2 |
Device: Multichannel Auditory Brain Stem Implant |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Study Start Date: | October 1999 |
| Estimated Study Completion Date: | October 2000 |
PROTOCOL OUTLINE: Patients undergo surgery to remove the first side or second side tumor, during which the multichannel auditory brain stem implant is implanted. Initial stimulation is conducted 4-6 weeks after surgery. Patients are followed every 3 months for the first year, then annually thereafter.
Eligibility| Ages Eligible for Study: | 12 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics-- Confirmed diagnosis of neurofibromatosis type 2 Scheduled to undergo first side or second side tumor removal First side implantation performed only on patients with onset of symptoms prior to age 40 --Prior/Concurrent Therapy-- If a nonfunctional auditory brain stem implant (ABI) is present (implanted during the removal of a first side tumor), a multichannel ABI may be implanted during the removal of a second side tumor --Patient Characteristics-- English is the primary language
Contacts and Locations More Information
| Study ID Numbers: | 199/13400, CC-FDR001283 |
| Study First Received: | October 18, 1999 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00004437 History of Changes |
| Health Authority: | United States: Federal Government |
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acoustic neuroma genetic diseases and dysmorphic syndromes hearing loss |
neurofibromatosis neurologic and psychiatric disorders rare disease |
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Vestibulocochlear Nerve Diseases Otorhinolaryngologic Neoplasms Neuroma, Acoustic Retrocochlear Diseases Neurodegenerative Diseases Ear Diseases Neurofibromatosis 1 Acoustic Neuroma Neurofibromatosis 2 Deafness Heredodegenerative Disorders, Nervous System Neurofibromatosis Type 1 Neurofibroma Neuromuscular Diseases Neurofibromatosis Type 2 |
Mental Disorders Neoplasms, Germ Cell and Embryonal Neuroepithelioma Hearing Loss Nervous System Neoplasms Neurocutaneous Syndromes Otorhinolaryngologic Diseases Rare Diseases Neurilemmoma Neuroendocrine Tumors Neuroectodermal Tumors Neoplastic Syndromes, Hereditary Genetic Diseases, Inborn Peripheral Nervous System Diseases Neurofibromatoses |
|
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 |
