Condition or disease | Intervention/treatment | Phase |
---|---|---|
Bilateral Vestibular Loss | Device: Cochlear Vestibular Implant (CVI) | Not Applicable |
The vestibular sensory organ is essential for balance and image stabilization. Patients with severe function loss of both vestibular organs present themselves with serious day-to-day disabilities such as strong balance disturbances, higher risk of falling, visual symptoms (oscillopsia) and a loss of autonomy. Up until now no effective treatment is available for these patients to restore vestibular function. In the past years experimental electric stimulation of the vestibular nerve in humans by means of a VI has shown to be able to partly restore balance and gaze functionality in test situations.
To evaluate combined prolonged stimulation of both the vestibular organ and the cochlea, participants will be implanted with a CVI. This modified CI also consists of 3 vestibular electrodes, each placed in individual electrode leads for insertion into the three semicircular canals. Therefore the CVI is capable of stimulating both the cochlear and vestibular nerves. Hearing rehabilitation with the CI part of the device will follow the standard clinical protocol, with the participant using a standard CI processor. Functionality of prolonged combined vestibular and cochlear stimulation will be assessed using a research processor during 3 weeks (3x4 days, +- 8 hours a day) of prolonged stimulation under supervision in the safety of a hospital environment.
During each identical period of 4 days a different stimulation algorithm will be used for vestibular stimulation, with the order being randomized and single-blinded. The stimulation algorithms which will be used are constant un-modulated stimulation, modulated stimulation based on angular head movement and modulated stimulation based on linear head movement. Alongside the 3 weeks of prolonged stimulation, the participant will make yearly visits to our clinic up to 5 years after implantation for evaluation of long-term response to acute vestibular stimulation and general CI performance.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 8 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Intervention Model Description: | Controlled clinical trial with a randomized single-blind 3-treatment 3-period crossover design |
Masking: | Single (Participant) |
Primary Purpose: | Device Feasibility |
Official Title: | VertiGO! - Get up and GO! With the Vestibular Implant |
Actual Study Start Date : | July 1, 2021 |
Estimated Primary Completion Date : | December 2023 |
Estimated Study Completion Date : | June 2027 |
Arm | Intervention/treatment |
---|---|
ABC
A = Unmodulated B = Angular modulation C = Linear modulation |
Device: Cochlear Vestibular Implant (CVI)
The Cochlear Vestibular Implant (CVI) is a modified cochlear implant (CI) which also incorporates a vestibular component (VI) in order to restore both hearing and vestibular function. Three vestibular stimulation algorithms will be compared in a randomized order (3 treatments x 3 periods, = 6 arms). These stimulation algorithms are:
|
ACB
A = Unmodulated C = Linear modulation B = Angular modulation |
Device: Cochlear Vestibular Implant (CVI)
The Cochlear Vestibular Implant (CVI) is a modified cochlear implant (CI) which also incorporates a vestibular component (VI) in order to restore both hearing and vestibular function. Three vestibular stimulation algorithms will be compared in a randomized order (3 treatments x 3 periods, = 6 arms). These stimulation algorithms are:
|
BAC
B = Angular modulation A = Unmodulated C = Linear modulation |
Device: Cochlear Vestibular Implant (CVI)
The Cochlear Vestibular Implant (CVI) is a modified cochlear implant (CI) which also incorporates a vestibular component (VI) in order to restore both hearing and vestibular function. Three vestibular stimulation algorithms will be compared in a randomized order (3 treatments x 3 periods, = 6 arms). These stimulation algorithms are:
|
BCA
B = Angular modulation C = Linear modulation A = Unmodulated |
Device: Cochlear Vestibular Implant (CVI)
The Cochlear Vestibular Implant (CVI) is a modified cochlear implant (CI) which also incorporates a vestibular component (VI) in order to restore both hearing and vestibular function. Three vestibular stimulation algorithms will be compared in a randomized order (3 treatments x 3 periods, = 6 arms). These stimulation algorithms are:
|
CAB
C = Linear modulation A = Unmodulated B = Angular modulation |
Device: Cochlear Vestibular Implant (CVI)
The Cochlear Vestibular Implant (CVI) is a modified cochlear implant (CI) which also incorporates a vestibular component (VI) in order to restore both hearing and vestibular function. Three vestibular stimulation algorithms will be compared in a randomized order (3 treatments x 3 periods, = 6 arms). These stimulation algorithms are:
|
CBA
C = Linear modulation B = Angular modulation A = Unmodulated |
Device: Cochlear Vestibular Implant (CVI)
The Cochlear Vestibular Implant (CVI) is a modified cochlear implant (CI) which also incorporates a vestibular component (VI) in order to restore both hearing and vestibular function. Three vestibular stimulation algorithms will be compared in a randomized order (3 treatments x 3 periods, = 6 arms). These stimulation algorithms are:
|
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion criteria:
Reduced or absent bilateral VOR function based on at least one of the tests below meeting criteria A, with the other tests meeting criteria B:
Criteria A: Caloric response: Each side ≤6°/sec, vHIT gain: Bilateral horizontal SCC ≤ 0.6 AND Bilateral vertical SCC <0.7, Rotatory chair gain: ≤ 0.1 (0.1 Hz)
Criteria B: Caloric response: Each side <10°/sec, vHIT gain: 2 Bilateral SCC <0.7, Rotatory chair gain: ≤ 0.2 (0.1 Hz)
Remark: Patients who qualify to receive a regular CI as part of standard clinical care will have a preferential position to be included in the trial.
Exclusion Criteria:
Contact: Raymond van de Berg, MD, PhD | +31 43 387 54 00 | contact@vestibularimplant.com | |
Contact: Elke MJ Devocht, MSc | +31 43 387 54 00 | contact@vestibularimplant.com |
Netherlands | |
Maastricht UMC+ | Recruiting |
Maastricht, Limburg, Netherlands, 6229 HX | |
Contact: Raymond van de Berg, MD, PhD +31 43 387 54 00 contact@vestibularimplant.com | |
Contact: Elke MJ Devocht, PhD +31 43 387 54 00 contact@vestibularimplant.com |
Principal Investigator: | Raymond van de Berg, MD, PhD | Maastricht UMC |
Tracking Information | |||||||||||||||||
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First Submitted Date ICMJE | April 28, 2021 | ||||||||||||||||
First Posted Date ICMJE | June 9, 2021 | ||||||||||||||||
Last Update Posted Date | July 27, 2021 | ||||||||||||||||
Actual Study Start Date ICMJE | July 1, 2021 | ||||||||||||||||
Estimated Primary Completion Date | December 2023 (Final data collection date for primary outcome measure) | ||||||||||||||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||||||||||||||
Change History | |||||||||||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||||||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||||||||||
Descriptive Information | |||||||||||||||||
Brief Title ICMJE | VertiGO! - Get up and GO! With the Vestibular Implant | ||||||||||||||||
Official Title ICMJE | VertiGO! - Get up and GO! With the Vestibular Implant | ||||||||||||||||
Brief Summary | In the VertiGO! trial 8 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 make use of this combined stimulation during 3 weeks of prolonged use under supervision in a hospital environment. 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. | ||||||||||||||||
Detailed Description |
The vestibular sensory organ is essential for balance and image stabilization. Patients with severe function loss of both vestibular organs present themselves with serious day-to-day disabilities such as strong balance disturbances, higher risk of falling, visual symptoms (oscillopsia) and a loss of autonomy. Up until now no effective treatment is available for these patients to restore vestibular function. In the past years experimental electric stimulation of the vestibular nerve in humans by means of a VI has shown to be able to partly restore balance and gaze functionality in test situations. To evaluate combined prolonged stimulation of both the vestibular organ and the cochlea, participants will be implanted with a CVI. This modified CI also consists of 3 vestibular electrodes, each placed in individual electrode leads for insertion into the three semicircular canals. Therefore the CVI is capable of stimulating both the cochlear and vestibular nerves. Hearing rehabilitation with the CI part of the device will follow the standard clinical protocol, with the participant using a standard CI processor. Functionality of prolonged combined vestibular and cochlear stimulation will be assessed using a research processor during 3 weeks (3x4 days, +- 8 hours a day) of prolonged stimulation under supervision in the safety of a hospital environment. During each identical period of 4 days a different stimulation algorithm will be used for vestibular stimulation, with the order being randomized and single-blinded. The stimulation algorithms which will be used are constant un-modulated stimulation, modulated stimulation based on angular head movement and modulated stimulation based on linear head movement. Alongside the 3 weeks of prolonged stimulation, the participant will make yearly visits to our clinic up to 5 years after implantation for evaluation of long-term response to acute vestibular stimulation and general CI performance. |
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Study Type ICMJE | Interventional | ||||||||||||||||
Study Phase ICMJE | Not Applicable | ||||||||||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Intervention Model Description: Controlled clinical trial with a randomized single-blind 3-treatment 3-period crossover design Masking: Single (Participant)Primary Purpose: Device Feasibility |
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Condition ICMJE | Bilateral Vestibular Loss | ||||||||||||||||
Intervention ICMJE | Device: Cochlear Vestibular Implant (CVI)
The Cochlear Vestibular Implant (CVI) is a modified cochlear implant (CI) which also incorporates a vestibular component (VI) in order to restore both hearing and vestibular function. Three vestibular stimulation algorithms will be compared in a randomized order (3 treatments x 3 periods, = 6 arms). These stimulation algorithms are:
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Study Arms ICMJE |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||||||||||
Recruitment Status ICMJE | Recruiting | ||||||||||||||||
Estimated Enrollment ICMJE |
8 | ||||||||||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||||||||||
Estimated Study Completion Date ICMJE | June 2027 | ||||||||||||||||
Estimated Primary Completion Date | December 2023 (Final data collection date for primary outcome measure) | ||||||||||||||||
Eligibility Criteria ICMJE |
Inclusion criteria:
Remark: Patients who qualify to receive a regular CI as part of standard clinical care will have a preferential position to be included in the trial. Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||||||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | Netherlands | ||||||||||||||||
Removed Location Countries | |||||||||||||||||
Administrative Information | |||||||||||||||||
NCT Number ICMJE | NCT04918745 | ||||||||||||||||
Other Study ID Numbers ICMJE | NL73492.068.20 METC20-087 ( Other Identifier: METC azM/UM ) |
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Has Data Monitoring Committee | Yes | ||||||||||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Maastricht University Medical Center | ||||||||||||||||
Study Sponsor ICMJE | Maastricht University Medical Center | ||||||||||||||||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | Maastricht University Medical Center | ||||||||||||||||
Verification Date | May 2021 | ||||||||||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |