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

This study has been completed.
Sponsor:
Collaborator:
Cochlear
Information provided by:
FDA Office of Orphan Products Development
ClinicalTrials.gov Identifier:
NCT00004437
First received: October 18, 1999
Last updated: June 23, 2005
Last verified: January 2001
History of Changes
  Purpose

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.


Condition Intervention Phase
Neurofibromatosis 2
 Device: Multichannel Auditory Brain Stem Implant
 Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by FDA Office of Orphan Products Development:

Study Start Date: October 1999
Estimated Study Completion Date: October 2000
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.

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004437

Sponsors and Collaborators
FDA Office of Orphan Products Development
Cochlear
Investigators
Study Chair: Steven J. Staller Cochlear
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00004437     History of Changes
Other Study ID Numbers: 199/13400, CC-FDR001283
Study First Received: October 18, 1999
Last Updated: June 23, 2005
Health Authority: United States: Federal Government

Keywords provided by FDA Office of Orphan Products Development:
acoustic neuroma
genetic diseases and dysmorphic syndromes
hearing loss
 neurofibromatosis
neurologic and psychiatric disorders
rare disease

Additional relevant MeSH terms:
Neurofibromatosis 2
Neurofibromatoses
Neuroma, Acoustic
Neurilemmoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neurofibroma
Nerve Sheath Neoplasms
Neoplasms, Nerve Tissue
Neuroma
Nervous System Neoplasms
 Neoplasms by Site
Neoplastic Syndromes, Hereditary
Vestibulocochlear Nerve Diseases
Retrocochlear Diseases
Ear Diseases
Otorhinolaryngologic Diseases
Otorhinolaryngologic Neoplasms
Cranial Nerve Neoplasms
Cranial Nerve Diseases
Nervous System Diseases
Neurocutaneous Syndromes
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn

ClinicalTrials.gov processed this record on May 16, 2013