Implantation of a vestibular prosthesis.
- Conditions
- cochlear implant, vestibular implant, vestibular prosthesis, bilateral vestibular areflexia, cochleair implant, vestibulair implantaat, vestibulaire prothese, bilateraal vestibulair functieverlies
- Registration Number
- NL-OMON22853
- Lead Sponsor
- Maastricht University Medical Centre (MUMC+)
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 5
Inclusion Criteria
1. Since vestibular surgery still has a risk of deafening the patients, the selected patients are >18 years old, have a bilateral loss of vestibular function with disabling symptoms and have a severe perceptive hearing loss in at least one ear (in other words: they are already deaf in the tested ear);
2. Giving informed consent.
Exclusion Criteria
1. Incapacitated patients;
2. 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 1. The gain, phase and direction of VOR will be measured and adjusted accordingly, with use of electronystagmography and video-nystagmography in function of frequency and amplitude of electric stimulation in the conditions mentioned below:<br /><br>A. Patients with different vestibular loss etiology;<br /><br>B. Stimulation of the superior, lateral and posterior ampullary nerve;<br /><br>C. 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 during activation of the implant).
- Secondary Outcome Measures
Name Time Method Assessment of the subjective patient’s feeling during adjustment of settings.