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ID
Source
Brief title
Health condition
cochlear implant, vestibular implant, vestibular prosthesis, bilateral vestibular areflexia, cochleair implant, vestibulair implantaat, vestibulaire prothese, bilateraal vestibulair functieverlies
Sponsors and support
Intervention
Outcome measures
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.
Background 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.
Study objective
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.
Study design
After vestibular examinations pre-operatively, implantation and follow-up will take one year.
Intervention
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.
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 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.
Design
Recruitment
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL2751 |
| NTR-old | NTR2890 |
| CCMO | NL36777.068.11 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |
| OMON | NL-OMON41428 |