Completed

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

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What is being tested

Multichannel Auditory Brain Stem Implant

Device
Who is being recruted

Vestibulocochlear Nerve Diseases+37

+ Cranial Nerve Diseases

+ Cranial Nerve Neoplasms

Over 12 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: October 1999
See protocol details

Summary

Principal SponsorFDA Office of Orphan Products Development
Last updated: March 25, 2015
Sourced from a government-validated database.Claim as a partner

Study start date: October 1, 1999

Actual date on which the first participant was enrolled.

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.

NCT00004437
Principal SponsorFDA Office of Orphan Products Development
Last updated: March 25, 2015
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 12 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Vestibulocochlear Nerve DiseasesCranial Nerve DiseasesCranial Nerve NeoplasmsEar DiseasesHearing DisordersCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesNeoplasmsNeoplasms by Histologic TypeNeoplasms by SiteNeoplasms, Germ Cell and EmbryonalNeoplasms, Nerve TissueNeoplastic Syndromes, HereditaryNervous System DiseasesNervous System NeoplasmsNeurilemmomaNeurofibromaNeuromaOtorhinolaryngologic DiseasesOtorhinolaryngologic NeoplasmsPathologic ProcessesPeripheral Nervous System NeoplasmsRetrocochlear DiseasesSensation DisordersSigns and SymptomsPathological Conditions, Signs and SymptomsNeuroectodermal TumorsNerve Sheath NeoplasmsNeuroendocrine TumorsNeurodegenerative DiseasesHeredodegenerative Disorders, Nervous SystemNeurocutaneous SyndromesDisease AttributesMental DisordersNeurologic ManifestationsNeuroma, AcousticNeurofibromatosis 2NeurofibromatosesGenetic Diseases, InbornHearing LossRare Diseases

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

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
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CompletedNo study centers