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ID
Source
Brief title
Health condition
Vestibular prosthesis
Vestibulaire prothese
Vestibular implant
Vestibulair implantaat
Bilateral vestibular loss
Bilateraal vestibulair functieverlies
Cochlear implant
Cochleair implantaat
Sponsors and support
Intervention
Outcome measures
Primary outcome
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:
1. Patients with different vestibular loss etiology;
2. Stimulation of the lateral ampullary nerve and posterior ampullary nerve;
3. Under general and local anesthesia.
Secondary outcome
Assessment of the subjective feelings during stimulaton of the ampullary nerves in local anesthesia, like vertigo or nausea.
Background summary
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.
Study objective
By sufficient electrical stimulation of the ampullary nerves, a congruent vestibulo-ocular reflex will occur.
Study design
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.
Intervention
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.
Raymond Berg, van de
Maastricht 6202 AZ
The Netherlands
+31 (0)43 3875400
rayvandeberg@hotmail.com
Raymond Berg, van de
Maastricht 6202 AZ
The Netherlands
+31 (0)43 3875400
rayvandeberg@hotmail.com
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 and are selected for cochlear implant surgery (in other words: they are already deaf);
2. Giving informed consent.
Exclusion criteria
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).
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL2185 |
| NTR-old | NTR2310 |
| CCMO | NL31405.068.10 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |