Vestibular implantation and inner ear preservatio
Not Applicable
Completed
- Conditions
- <p>bilateral vestibulopathy</p>10022396
- Registration Number
- NL-OMON22960
- Lead Sponsor
- Academic hospital Maastricht (azM), The Netherlands
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 10
Inclusion Criteria
- Having a disease that requires destructive surgery of the labyrinth
- Having residual hearing that can be monitored using Auditory Brainstem Response (ABR)
Exclusion Criteria
- Mentally incapacitated patients
- Carrier of any other implanted electronic device (e.g. pace-maker)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>1. Assessment of preserved auditory function when the membranous labyrinth is kept intact.<br /><br>2. Assessment of preserved auditory function after the membranous labyrinth is perforated with an electrode, which closes the opening directly.<br /><br>3. Assessment of preserved auditory function after electrode manipulation.<br /><br>4. Assessment of preserved auditory function after vestibular implantation, i.e. opening of the whole labyrinth and leakage of endolymph.</p><br>
- Secondary Outcome Measures
Name Time Method <p>5. Assessment of preserved vestibular function for different electrode positions with an electrode inside the semicircular canals.<br /><br>6. Assessment of damage on tissue and cellular level with histopathological examination of labyrinths.</p><br>