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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00004437

Enrollment

Unknown

Registered

1999-10-19

Start date

1999-10-31

Completion date

2000-10-31

Last updated

2015-03-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neurofibromatosis 2

Keywords

acoustic neuroma, genetic diseases and dysmorphic syndromes, hearing loss, neurofibromatosis, neurologic and psychiatric disorders, rare disease

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. 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.

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.

Interventions

DEVICEMultichannel Auditory Brain Stem Implant

Study design

Primary purpose

TREATMENT

Eligibility

Sex/Gender

ALL

Age

12 Years to No maximum

Healthy volunteers

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026