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

Tracking Information

First Received Date ^ICMJE

October 18, 1999

Last Updated Date

June 23, 2005

Start Date ^ICMJE

October 1999

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00004437 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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.

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment

Condition ^ICMJE

Neurofibromatosis 2

Intervention ^ICMJE

Device: Multichannel Auditory Brain Stem Implant

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

October 2000

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

12 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Administrative Information

NCT ID ^ICMJE

NCT00004437

Responsible Party

Study ID Numbers ^ICMJE

199/13400, CC-FDR001283

Study Sponsor ^ICMJE

FDA Office of Orphan Products Development

Collaborators ^ICMJE

Cochlear

Investigators ^ICMJE

Study Chair:

Steven J. Staller

Cochlear

Information Provided By

FDA Office of Orphan Products Development

Verification Date

January 2001

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP