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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
NameTimeMethod
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
NameTimeMethod
Assessment of the subjective patient’s feeling during adjustment of settings.
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