Phase II Study of the Multichannel Auditory Brain Stem Implant for Deafness Following Surgery for Neurofibromatosis 2

Sponsor

FDA Office of Orphan Products Development (U.S. Fed)

Overall Status

Completed

CT.gov ID

NCT00004437

Collaborator

Cochlear (Industry)

Duration (Months)

Study Details

Study Description

Brief Summary

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.

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.
Evaluate performance and learning effects using optimized fitting procedures.

Condition or Disease	Intervention/Treatment	Phase
Neurofibromatosis 2	Device: Multichannel Auditory Brain Stem Implant	Phase 2

Detailed Description

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.

Study Design

Study Type:

Interventional

Primary Purpose:

Treatment

Study Start Date :

Oct 1, 1999

Study Completion Date :

Oct 1, 2000

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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