Implantation of a vestibular prosthesis

Completed

• Conditions: 10009720; balance disorder; bilateral vestibular loss; 10022396

• Registration Number: NL-OMON41428
• Lead Sponsor: Medisch Universitair Ziekenhuis Maastricht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 11 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 7

Inclusion Criteria

More than 18 years old
Symptomatic bilateral loss of vestibular function
A severe perceptive hearing loss in at least one ear
Giving informed consent

Exclusion Criteria

Incapacitated patients
Carrier of any other implanted electronic device (e.g. pace-maker)
Contra-indication for general anesthesia

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>1. The gain, phase and direction of VOR will be measured and adjusted<br /><br>accordingly, with use of electronystagmography and video-nystagmography in<br /><br>function of frequency and amplitude of electric stimulation in the conditions<br /><br>mentioned below:<br /><br>-- Patients with different vestibular loss etiology<br /><br>-- Stimulation of the superior, lateral and posterior ampullary nerve<br /><br>-- Using a long-term implanted vestibular prosthesis<br /><br>2. Performance in balance tests (routine ENG-examination)<br /><br>3. Questionnaires about subjective parameters<br /><br>4. Audiometric results pre- and postoperatively (including audiometric results<br /><br>during activation of the implant) </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Assessment of the subjective patient*s feeling during adjustment of settings</p><br>