A Phase 2 interventional study of Multichannel Auditory Brain Stem Implant in Neurofibromatosis 2, sponsored by FDA Office of Orphan Products Development. Completed. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2015-03-25.
Sponsored by FDA Office of Orphan Products Development · Phase 2, Interventional, and Treatment
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.
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.
186 studies on the registry are indexed under Neurofibromatoses; 24 are open to participants now.
Browse Neurofibromatoses studies →FDA Office of Orphan Products Development is the lead sponsor of 31 studies on the registry; none are open to participants now.
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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
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This study is completed, as verified in Jan 2001. You cannot join it, but the record below documents what was studied.
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FDA Office of Orphan Products Development