Monitoring of auditory and vestibular function during destructive labyrinth surgery

Completed

Conditions: balance disorder
bilateral vestibular loss
10022396

Registration Number: NL-OMON55774

Lead Sponsor: Medisch Universitair Ziekenhuis Maastricht

Brief Summary: Trial is onging in other countries

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 22

Inclusion Criteria

- Patient has a disease that requires destructive surgery of the labyrinth
- Patient has residual hearing that can be monitored using BERA
- Patient is older than 18 years
- Patient gives informed consent

Exclusion Criteria

- Patient is mentally incapacitated
- Patient is carrier of any other implanted electronic device (e.g. pace-maker)
- Patient has an enlarged vestibular aqueduct on routinely made preoperative
CT-scan

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>1. Assessment of preserved auditory function when the membranous labyrinth is<br /><br>kept intact<br /><br>2. Assessment of preserved auditory function after the membranous labyrinth is<br /><br>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</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>5. Assessment of preserved vestibular function with an electrode inside the<br /><br>semicircular canals<br /><br>6. Assessment of damage on tissue and cellular level with histopathological<br /><br>examination of labyrinths after vestibular implantation</p><br>