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VertiGO! - Get up and GO! With the Vestibular Implant

StatusActive, Not Recruiting
PhaseNot applicable
Started
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Record History

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  1. Interventions modified
    • Eligibility criteria expanded, about 158 words
    • Secondary endpoints: details revised at 11 of 11 entries
    • Publications: details revised at 30 of 30 entries
  2. Primary completion date: Dec 2024 to Jun 30, 2027v7 Show 5 more changesShow less
    • Primary endpoints: 13 to 14
    • Study completion date: Jun 2027 to Jun 30, 2029
    • Study description expanded, about 227 words
    • Collaborators: 5 to 6
    • Study arms: 6 to 12
  3. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised
    v6
  4. Primary completion date: Dec 2023 to Dec 2024v5
  5. Enrollment target: 8 to 13
    • Study description expanded, about 2 words
    v4
Show 2 earlier versionsHide 2 earlier versions
  1. Re-verified, no change to tracked fieldsv3
  2. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jun 2021 to Jul 1, 2021
    • Site details revised
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 organ stimulation while also taking into account the patient perspective.
Trial Details
NCT Number NCT04918745
Lead Sponsor Maastricht University Medical Center
Collaborators: University Hospital, Geneva, MED-EL Elektromedizinische Geräte GesmbH, Health Holland, Heinsius-Houbolt Fund, Radboud University Medical Center, Stichting de Weijerhorst
Conditions
(from sponsor)		 Bilateral Vestibular Loss
Related terms Bilateral Vestibulopathy
Enrollment 13 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov