Phase 2
12 Years
N/A
12 Years
N/A
Not Enrolling
Both
Neurofibromatosis 2
Both
Neurofibromatosis 2
Trial Information
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.
Inclusion Criteria
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
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
Steven J. Staller
Investigator Role:
Study Chair
Investigator Affiliation:
Cochlear
Authority:
United States: Federal Government
Study ID:
199/13400
NCT ID:
NCT00004437
Start Date:
October 1999
Completion Date:
October 2000
Related Keywords:
- Neurofibromatosis 2
- acoustic neuroma
- genetic diseases and dysmorphic syndromes
- hearing loss
- neurofibromatosis
- neurologic and psychiatric disorders
- rare disease
- Neurofibromatoses
- Neurofibromatosis 1
- Osteitis Fibrosa Cystica
- Neurofibromatosis 2
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