No phaseActive, not recruiting
VertiGO! - Get up and GO! With the Vestibular Implant
- Sponsor
- Maastricht University Medical Center (Academic or other)
- Enrolment
- 13 planned
- Conditions
- Bilateral Vestibular Loss
- Interventions
- Cochlear Vestibular Implant (CVI) - in-hosptial; Cochlear Vestibular Implant (CVI) - home-use (preference)
- Ages
- adults, older adults
- Registry
- NCT04918745
Full record on ClinicalTrials.gov
From the registry
In the VertiGO! trial 13 participants with bilateral vestibulopathy (BV) and severe sensory neural hearing loss in the ear to be implanted will receive a combined cochlear (CI) and vestibular implant (VI), capable of stimulating both the cochlear and vestibular nerves (CVI). The participants will firstly make use of this combined stimulation during 3 weeks of prolonged use under direct supervision in a hospital environment. Following this, participants will make use of combined stimulation in a real-life environment (e.g., outside of the hospital setting) for 15 months under indirect supervision. This trial will serve as a proof-of-concept for restoring vestibular function in patients with BV, an as-of-yet untreatable disorder causing severe impairment and discomfort. The aims of this trial are to investigate efficacy and safety of prolonged vestibular stimulation, to identify the influence of different stimulation algorithms, to assess the feasibility of the combined VI/CI device, to develop a VI rehabilitation program and to further build on the fundamental knowledge of vestibular…
Primary outcomes
- Safety of vestibular stimulation via the CVI
- The feasibility of vestibular stimulation improving Dynamic Visual Acuity during walking
- The feasibility of vestibular stimulation improving Dynamic Visual Acuity during passive head movements
- The feasibility of vestibular stimulation restoring the high-frequency vestibulo-ocular reflex
History
Study completion expected
Primary completion expected
Last registry update
Started
Registered