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…
ID
Bron
Verkorte titel
Aandoening
cochlear implant, vestibular implant, vestibular prosthesis, bilateral vestibular areflexia, cochleair implant, vestibulair implantaat, vestibulaire prothese, bilateraal vestibulair functieverlies
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
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:<br>
A. Patients with different vestibular loss etiology;<br>
B. Stimulation of the superior, lateral and posterior ampullary nerve;<br>
C. Using a long-term implanted vestibular prosthesis.<br>
2. Performance in balance tests (routine ENG-examination);<br>
3. Questionnaires about subjective parameters;<br>
4. Audiometric results pre- and postoperatively (including audiometric results during activation of the implant).
Achtergrond van het onderzoek
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.
Doel van het onderzoek
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.
Onderzoeksopzet
After vestibular examinations pre-operatively, implantation and follow-up will take one year.
Onderzoeksproduct en/of interventie
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.
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 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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. Incapacitated patients;
2. Carrier of any other implanted electronic device (e.g. pace-maker);
3. Contra-indication for general anesthesia.
Opzet
Deelname
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL2751 |
| NTR-old | NTR2890 |
| CCMO | NL36777.068.11 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |
| OMON | NL-OMON41428 |