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Implantation of a vestibular prosthesis.


- candidate number9420
- NTR NumberNTR2890
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR10-mei-2011
- Secondary IDsNL36777.068.11 CCMO
- Public TitleImplantation of a vestibular prosthesis.
- Scientific TitleImplantation of a vestibular prosthesis.
- ACRONYMVI
- hypothesis1. 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) studiedVestibular prothesis, Cochlear implant, Vestibular implant, Bilateral vestibular areflexia
- Inclusion criteria1. 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 criteria1. Incapacitated patients;
2. Carrier of any other implanted electronic device (e.g. pace-maker);
3. Contra-indication for general anesthesia.
- mec approval receivedno
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-jul-2011
- planned closingdate1-jul-2012
- Target number of participants5
- Interventions1. 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 outcome1. 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 outcomeAssessment of the subjective patient’s feeling during adjustment of settings.
- TimepointsAfter vestibular examinations pre-operatively, implantation and follow-up will take one year.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIESAIOS Raymond Berg, van de
- CONTACT for SCIENTIFIC QUERIESAIOS Raymond Berg, van de
- Sponsor/Initiator Maastricht University Medical Center (MUMC+)
- Funding
(Source(s) of Monetary or Material Support)
Maastricht University Medical Center (MUMC+)
- PublicationsN/A
- Brief summaryA 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)
- RECORD10-mei-2011 - 18-mei-2011


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