|- candidate number||9420|
|- NTR Number||NTR2890|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||10-mei-2011|
|- Secondary IDs||NL36777.068.11 CCMO|
|- Public Title||Implantation of a vestibular prosthesis.|
|- Scientific Title||Implantation of a vestibular prosthesis.|
|- hypothesis||1. By implanting a vestibular prosthesis which provides sufficient electrical stimulation of the ampullary nerves, a congruent vestibulo-ocular reflex (VOR) will occur;|
2. The parameters of the VOR can be modified by adjusting the settings of the vestibular implant;
3. Using the vestibular implant will lead to improvement of objective and subjective vestibular parameters.
|- Healt Condition(s) or Problem(s) studied||Vestibular prothesis, Cochlear implant, Vestibular implant, Bilateral vestibular areflexia|
|- 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);
3. Contra-indication for general anesthesia.
|- mec approval received||no|
|- multicenter trial||no|
|- Type||Single arm|
|- planned startdate ||1-jul-2011|
|- planned closingdate||1-jul-2012|
|- Target number of participants||5|
|- Interventions||1. To implant a functional vestibular prosthesis using the ampullar “V”-approach, as developed in our own clinic.|
2. To investigate protocols for adjusting the vestibular implant (VI) to required settings, regarding:
A. Modulation sensitivity;
B. Baseline firing rate and current;
C. VOR-axis, using precompensation.
3. To investigate the benefit of the vestibular implant regarding:
A. Objective parameters (balance test results);
B. Subjective parameters (quality of life, etc.).
4. To investigate interference with hearing during vestibular stimulation;
5. To investigate adaptation of the brain to the vestibular implant.
|- Primary outcome||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:|
A. Patients with different vestibular loss etiology;
B. Stimulation of the superior, lateral and posterior ampullary nerve;
C. Using a long-term implanted vestibular prosthesis.
2. Performance in balance tests (routine ENG-examination);
3. Questionnaires about subjective parameters;
4. Audiometric results pre- and postoperatively (including audiometric results during activation of the implant).
|- Secondary outcome||Assessment of the subjective patient’s feeling during adjustment of settings.|
|- Timepoints||After vestibular examinations pre-operatively, implantation and follow-up will take one year.|
|- 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||A vestibular prosthesis will be implanted and adjusted, until desired responses from the vestibular system are obtained. This is a main step in developing the vestibular implant.|
|- Main changes (audit trail)|
|- RECORD||10-mei-2011 - 18-mei-2011|