Implantation of a vestibular prosthesis.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON22853

Enrollment

Registered

2011-05-10

Start date

2011-07-01

Completion date

Unknown

Last updated

2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

cochlear implant, vestibular implant, vestibular prosthesis, bilateral vestibular areflexia, cochleair implant, vestibulair implantaat, vestibulaire prothese, bilateraal vestibulair functieverlies

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 set

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.

Eligibility

Inclusion criteria

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

Exclusion criteria: 1. Incapacitated patients; 2. Carrier of any other implanted electronic device (e.g. pace-maker); 3. Contra-indication for general anesthesia.

Design outcomes

Primary

Measure	Time frame
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).	—

Measure

Time frame

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

Measure	Time frame
Assessment of the subjective patient’s feeling during adjustment of settings.	—

Contacts

Public ContactRaymond Berg, van de

Postbus 5800

rayvandeberg@hotmail.com+31 (0)43 3875400

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)