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
  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:


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
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
Neurofibromatosis 1
Osteitis Fibrosa Cystica
Neurofibroma
Nerve Sheath Neoplasms
Neoplasms, Nerve Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplastic Syndromes, Hereditary
Neurocutaneous Syndromes
Nervous System Diseases
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn
Peripheral Nervous System Diseases
Neuromuscular Diseases
Bone Diseases, Endocrine
Bone Diseases
Musculoskeletal Diseases
Neuroma, Acoustic
Neurilemmoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neuroma
Nervous System Neoplasms
Neoplasms by Site
Vestibulocochlear Nerve Diseases
Retrocochlear Diseases

ClinicalTrials.gov processed this record on April 17, 2014