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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 |
| Genetics Home Reference related topics: | familial encephalopathy with neuroserpin inclusion bodies neurofibromatosis type 2 nonsyndromic deafness |
| MedlinePlus related topics: | Hearing Disorders and Deafness Neurofibromatosis |
| 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 |
| First Received: | October 18, 1999 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00004437 |
| Health Authority: | United States: Federal Government |
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