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

Neurofibromatosis 2 Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00004437
• Other study ID #: 199/13400
• Secondary ID: CC-FDR001283
• Status: Completed
• Phase: Phase 2
• First received: October 18, 1999
• Last updated: March 24, 2015
• Start date: October 1999
• Est. completion date: October 2000

Study information

• Verified date: January 2001
• Source: FDA Office of Orphan Products Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: October 2000
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years and older

Eligibility

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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neurofibroma
• Neurofibromatoses
• Neurofibromatosis 2

Intervention

Device:
• Multichannel Auditory Brain Stem Implant

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
FDA Office of Orphan Products Development	Cochlear