By sufficient electrical stimulation of the ampullary nerves, a congruent vestibulo-ocular reflex will occur.
ID
Bron
Verkorte titel
Aandoening
Vestibular prosthesis
Vestibulaire prothese
Vestibular implant
Vestibulair implantaat
Bilateral vestibular loss
Bilateraal vestibulair functieverlies
Cochlear implant
Cochleair implantaat
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
The gain, phase and direction of VOR will be measured with electronystagmography and video-nystagmography in function of frequency and amplitude of electric stimulation in the conditions mentioned below:<br>
1. Patients with different vestibular loss etiology;<br>
2. Stimulation of the lateral ampullary nerve and posterior ampullary nerve;<br>
3. Under general and local anesthesia.
Achtergrond van het onderzoek
We try to determine the best stimulation profile and surgical technique which lead to an optimal response (congruent vestibulo-ocular reflex) when stimulating the ampullary nerve. This is a main step in developing the vestibular implant.
Doel van het onderzoek
By sufficient electrical stimulation of the ampullary nerves, a congruent vestibulo-ocular reflex will occur.
Onderzoeksopzet
Apart from extra vestibular tests and questionnaires in order to confirm the bilateral vestibular loss and disability, the procedure during cochlear surgery is the only intervention where all the data is collected.
Onderzoeksproduct en/of interventie
The intervention only takes 20 minutes and is performed during surgery for cochlear implantation.
The beginning of the procedure will be done under local anesthesia. The posterior ampullary nerve and the lateral ampullary nerves (parts of the vestibular nerve) will be exposed with the approache described by Guyot et al. The electric stimulation of the nerve will be done following the established profile (pulsatile stimulation, different stimuli patterns), eyes movement will be registered with electronystagmography and video-nystagmography (routinely used). Then general anesthesia will be induced. A last electric stimulation following the established profile will be done. Then cochlear implantation will be performed as usual.
There is no control group.
Publiek
Raymond Berg, van de
Maastricht 6202 AZ
The Netherlands
+31 (0)43 3875400
rayvandeberg@hotmail.com
Wetenschappelijk
Raymond Berg, van de
Maastricht 6202 AZ
The Netherlands
+31 (0)43 3875400
rayvandeberg@hotmail.com
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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 and are selected for cochlear implant surgery (in other words: they are already deaf);
2. Giving informed consent.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
Patients should be able to undergo balance tests and electric stimulation of the ampullary nerves should not interfere with other electric devises. Therefore, the exclusion criteria are:
1. Incapacitated patients;
2. Carrier of any other implanted electronic device (e.g. pace-maker).
Opzet
Deelname
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| Register | ID |
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