|- candidate number||8037|
|- NTR Number||NTR2310|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||1-mei-2010|
|- Secondary IDs||NL31405.068.10 METC CCMO|
|- Public Title||Electric stimulation of the ampullary nerves.|
|- Scientific Title||Electric stimulation of the ampullary nerves in patients with complete bilateral vestibular loss.|
|- hypothesis||By sufficient electrical stimulation of the ampullary nerves, a congruent vestibulo-ocular reflex will occur.|
|- Healt Condition(s) or Problem(s) studied||Cochlear implant , Bilateral vestibular loss, Vestibular prothesis, Vestibular implant|
|- 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).
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||Single arm|
|- planned startdate ||1-jun-2010|
|- planned closingdate||1-jun-2011|
|- Target number of participants||20|
|- Interventions||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.
|- 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.|
|- Timepoints||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.|
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES||AIOS Raymond Berg, van de|
|- CONTACT for SCIENTIFIC QUERIES||AIOS Raymond Berg, van de|
|- Sponsor/Initiator ||Maastricht University Medical Center (MUMC+)|
(Source(s) of Monetary or Material Support)
|Maastricht University Medical Center (MUMC+)|
|- Brief 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.|
|- Main changes (audit trail)|
|- RECORD||1-mei-2010 - 10-jun-2010|