Know Cancer

or
forgot password

Penetrating Auditory Brainstem Implant for Neurofibromatosis 2


Phase 1
18 Years
N/A
Not Enrolling
Both
Neurofibromatosis 2

Thank you

Trial Information

Penetrating Auditory Brainstem Implant for Neurofibromatosis 2


Neurofibromatosis Type 2 (NF2) is characterized by multiple tumors of the cranial and spinal
nerves, and, in particular, by bilateral acoustic tumors. Surgical resection of these tumors
generally results in the transection of the VIIIth nerve, destruction of the cochlea and
auditory nerve, and total hearing loss. Due to the loss of the auditory nerve, these
patients are not candidates for cochlear implantation. The Auditory Brainstem Implant (ABI)
provides the only available intervention to restore some auditory sensation to these
patients. An ABI is an implantable prosthesis that produces sound sensation by electrical
stimulation of the ascending auditory pathway at the level of the cochlear nucleus.

The PABI may be placed surgically during tumor resection. Efficacy will be assessed using
psychophysical and standard speech reception measures.

Inclusion Criteria


Inclusion criteria:

- Diagnosis of neurofibromatosis type 2

- Speak English as a primary language

Exclusion criteria:

- Physical, psychological, or medical conditions that contraindicate the surgical
procedure

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Masking: Open Label, Primary Purpose: Treatment

Authority:

United States: Federal Government

Study ID:

FD-R-001969-01

NCT ID:

NCT00030043

Start Date:

September 2001

Completion Date:

August 2003

Related Keywords:

  • Neurofibromatosis 2
  • Electric Stimulation
  • Implants, Artificial
  • Brainstem
  • Electrodes
  • Speech Perception
  • Neurofibromatoses
  • Neurofibromatosis 1
  • Osteitis Fibrosa Cystica
  • Neurofibromatosis 2

Name

Location

House Ear InstituteLos Angeles, California  90057-9927
Huntington Medical Research InstitutesPasadena, California  
Cochlear CorporationEnglewood, Colorado