Bilateral Vestibular LossNCT04918745
VertiGO! - Get up and GO! With the Vestibular Implant
A study testing Cochlear Vestibular Implant (CVI) - in-hosptial and Cochlear Vestibular Implant (CVI) - home-use (preference) in people with Bilateral Vestibular Loss, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bilateral Vestibular Loss
- What is being tested?
- Cochlear Vestibular Implant (CVI) - in-hosptial and Cochlear Vestibular Implant (CVI) - home-use (preference)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Jul 2021to 30 Jun 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic vestibular syndrome being presented by disabling symptoms of postural imbalance and/or impaired image stabilization (e.g. oscillopsia)
- 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)
- Onset of bilateral vestibular loss after the age of 2
- Vestibular dysfunction from a peripheral origin or idiopathic BV
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- Patent vestibular end-organ (judged by CT)
- Vestibular function and symptoms have not recovered beyond inclusion criteria within 6 months from onset of symptoms including a 3 month rehabilitation program off vestibular suppressant medications
- Meeting CI-candidacy in ear to implant with CVI
- Agreed to receive a MED-EL CVI implant with MED-EL sound processor
- Capacitated adults ≥ 18 years
- Proficient speaker of the Dutch language
- No contra-indications for CVI surgery
- Active participation in the trial related procedures such as regular testing, the VI fitting period, the baseline testing day and three weeks of intensive VI rehabilitation and testing in the study center (MUMC+) including an exercise regimen
- Agreed not to swim or to use or operate vehicles, heavy machinery, powered tools or other devices that could pose a threat to the participant, to others, or to property throughout the period of VI activation and until at least 1 day after VI deactivation
- 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.
- Remark: In extreme circumstances, if an acute emergency case arises and it is determined that immediate intervention is required, the patient may be included. This exception is justified by a 'now-or-never' principle. Delaying implantation would likely result in irreversible progression of the condition, rendering the organ no longer viable/ patent. These patients will not have the opportunity to be placed on a waiting list or undergo surgery at a later stage. In past cases of this nature, the DSMB has been assembled to provide an objective review on whether the patient should be included. From VertiGO! Protocol version 4.8 onwards, all future cases of this nature will be filed to the METC committee prior to inclusion, with a request for urgent feedback based on the pressing nature of the case.
Who cannot join
- Signs of central vestibular/cochlear dysfunction or structural vestibular/cochlear nerve pathology (judged by physical examination / MRI)
- Clear signs of structural nerve pathology or indications of improperly functioning vestibular/cochlear nerves
- Requirement for electric-acoustic activation of the CI part (e.g. "hybrid" processor) prior to completion of the prolonged VI stimulation period
- Having received a cochlear implant earlier on the side to implant (e.g. explantation/reimplantation)
- Having received a cochlear implant from another brand than MED-EL in the other ear (bilateral implantation with different brands is not supported)
- Unwillingness to stop the use of antihistamines which might suppress VOR responses (e.g. cinnarizine) in the period of 1 month before until after each measurement point.
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- Pre-lingual onset of bilateral profound deafness (< 4 years of age)
- Active participation in another prospective clinical trial
- Pregnancy or having plans to become pregnant at the time of imaging or during the VI trial
- Orthopedic, ocular, neurologic or other non-vestibular pathologic conditions of sufficient severity to confound vestibular function tests used in the study
- Current psychological or psychiatric disorders that could significantly interfere with the use or evaluation of VI stimulation
- Physical or non-physical contraindications for MRI or CT imaging prior to surgery
- Making chronic use of psychiatric medication which suppresses VOR responses (e.g. SSRI's, benzodiazepines)
- Significant dental problems which prohibit the stable use of a 'bite bar' (used as calibration reference for the gyroscope functionality of the CVI)
- Any medical condition, judged by the research team, that is likely to interfere with a study candidate's participation in the study
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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 first be assessed using a research processor during 3 weeks (3x4 days, +- 8 hours a day) of prolonged stimulation under direct supervision in the safety of a hospital environment. This is considered the in-hospital part. Following this, a modified research processor will be used during 15 months (13 visits, half and full day) of prolonged stimulation in real-life situations under indirect supervision. This is considered the home-use part of the trial.
During the in-hospital part, 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 (1) baseline stimulation without motion modulation, (2) baseline stimulation with motion modulation, and (3) reduced baseline stimulation with motion modulation.
During the home-use part, the efficacy and safety of prolonged VI stimulation will be evaluated in a home environment using pre-post intervention evaluation. During this part, the stimulation status will alternate between VI-ON and VI-OFF, depending on the phase. The stimulation algorithm will be optimized per patients to best evaluate VI efficacy (optimization phase). Furthermore, safety and efficacy will be further elucidated by maintaining consistent prolonged VI stimulation (persistency phase), using a consistent algorithm with minimal adjustments. Following this, a resting period of at least four weeks (washout phase) will commence, where no VI stimulation will be used. This will allow for comparison between vestibular stimulation (VI-ON) versus without stimulation (VI-OFF), which aligns with the primary comparison used during the in-hospital period. In addition, this phase aims to minimize carry-over effect, ensure adequate resolution of aftereffects and evaluation of changes to quality of life. Finally, evaluation of single blinded preference between stimulation statuses will be assessed (preference phase). Patients will have the option to continue using vestibular stimulation after the preference phase for as long as the trial continues (resume phase).
Alongside the periods 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.
- Conditions
- Bilateral Vestibular Loss
- Being tested
- Cochlear Vestibular Implant (CVI) - in-hosptial, Cochlear Vestibular Implant (CVI) - home-use (preference)
- Keywords
- Vestibular Implant, Cochlear vestibular implant, Bilateral vestibulopathy, Bilateral vestibular hypofunction, Bilateral vestibular loss, Cochlear implant
- Medical subject headings
- Bilateral Vestibulopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cochlear Vestibular Implant (CVI) - in-hosptialDevice
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.
During the in-hospital part, three vestibular stimulation algorithms will be compared in a randomized order (3 treatments x 3 periods, = 6 arms). These stimulation algorithms are:
- A - Baseline stimulation, no modulation stimulation
- B - Baseline stimulation, modulated stimulation
- C - Reduced baseline stimulation, modulated stimulation
Cochlear Vestibular Implant (CVI) - home-use (preference)Device
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. During the home-use part, a preference phase will be included to assess the effects of a "control". Participants will receive two research processors, each with a different vestibular stimulation mode. These modes will be randomized over a 4-week period, each appearing twice (2 treatments appearing twice each x 4 weeks = 6 arms). These stimulation modes are:
- 1: Stimulation Mode 1
- 2: Stimulation Mode 2
| Study group | Role | What they receive |
|---|---|---|
| ABC | Other | In-hospital part
A = Baseline stimulation, no modulation
B = Baseline stimulation, modulation stimulation
C = Reduced baseline stimulation, modulation stimulation Receives: Device: Cochlear Vestibular Implant (CVI) - in-hosptial |
| ACB | Other | In-hospital part
A = Baseline stimulation, no modulation
C = Reduced baseline stimulation, modulation stimulation
B = Baseline stimulation, modulation stimulation Receives: Device: Cochlear Vestibular Implant (CVI) - in-hosptial |
| BAC | Other | In-hospital part
B = Baseline stimulation, modulation stimulation
A = Baseline stimulation, no modulation
C = Reduced baseline stimulation, modulation stimulation Receives: Device: Cochlear Vestibular Implant (CVI) - in-hosptial |
| BCA | Other | In-hospital part
B = Baseline stimulation, modulation stimulation
C = Reduced baseline stimulation, modulation stimulation
A = Baseline stimulation, no modulation Receives: Device: Cochlear Vestibular Implant (CVI) - in-hosptial |
| CAB | Other | In-hospital part
C = Reduced baseline stimulation, modulation stimulation
A = Baseline stimulation, no modulation
B = Baseline stimulation, modulation stimulation Receives: Device: Cochlear Vestibular Implant (CVI) - in-hosptial |
| CBA | Other | In-hospital part
C = Reduced baseline stimulation, modulation stimulation
B = Baseline stimulation, modulation stimulation
A = Baseline stimulation, no modulation Receives: Device: Cochlear Vestibular Implant (CVI) - in-hosptial |
| 1122 | Other | Home-use part, preference phase
1. - Stimulation Mode 1,
2. - Stimulation Mode 2 Receives: Device: Cochlear Vestibular Implant (CVI) - home-use (preference) |
| 1212 | Other | Home-use part, preference phase
1. - Stimulation Mode 1,
2. - Stimulation Mode 2 Receives: Device: Cochlear Vestibular Implant (CVI) - home-use (preference) |
| 1221 | Other | Home-use part, preference phase
1. - Stimulation Mode 1,
2. - Stimulation Mode 2 Receives: Device: Cochlear Vestibular Implant (CVI) - home-use (preference) |
| 2211 | Other | Home-use part, preference phase
1. - Stimulation Mode 1,
2. - Stimulation Mode 2 Receives: Device: Cochlear Vestibular Implant (CVI) - home-use (preference) |
| 2121 | Other | Home-use part, preference phase
1. - Stimulation Mode 1,
2. - Stimulation Mode 2 Receives: Device: Cochlear Vestibular Implant (CVI) - home-use (preference) |
| 2112 | Other | Home-use part, preference phase
1. - Stimulation Mode 1,
2. - Stimulation Mode 2 Receives: Device: Cochlear Vestibular Implant (CVI) - home-use (preference) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of vestibular stimulation via the CVI
Amount of (S)AE's after implantation to determine safety of the device
Measured: Through full trial period, or up to 5 years postoperatively
The feasibility of vestibular stimulation improving Dynamic Visual Acuity during walking
Quantifying vestibulo-ocular reflex restoration on a functional level by evaluating the capacity of vestibular stimulation (via the CVI) to improve dynamic visual acuity while walking. Adaptation to stimulation will be evaluated through each 4-day stimulation period during the in-hospital part (with each stimulation algorithm being evaluated separately) and during each hospital visit during the home-use part.
Measured: Through all stimulation periods, within 5 years after implantation
The feasibility of vestibular stimulation improving Dynamic Visual Acuity during passive head movements
Quantifying vestibulo-ocular reflex restoration on a functional level by evaluating the capacity of vestibular stimulation (via the CVI) to improve dynamic visual acuity during fast passive head movements measured with the functional Head Impulse Test. Adaptation to stimulation will be evaluated through each 4-day stimulation period during the in-hospital part (with each stimulation algorithm being evaluated separately) and during each hospital visit during the home-use part.
Measured: Through each 4-day VI stimulation period during the in-hospital part, throughout selective moments out of 13 total visits (15 months) during the home-use part
The feasibility of vestibular stimulation restoring the high-frequency vestibulo-ocular reflex
Evaluating the capacity of vestibular stimulation (via the CVI) to increase vestibulo-ocular reflex gain during fast passive head movements in the LHRH, RALP and LARP planes measured with the video Head Impulse Test. Adaptation to stimulation will be evaluated through each 4-day stimulation period during the in-hospital part (with each stimulation algorithm being evaluated separately) and during each hospital visit during the home-use part.
Measured: Through each 4-day VI stimulation period during the in-hospital part, throughout selective moments out of 13 total visits (15 months) during the home-use part
The feasibility of vestibular stimulation restoring the low-frequency vestibulo-ocular reflex
Evaluating the capacity of vestibular stimulation (via the CVI) to increase vestibulo-ocular reflex gain during slow, passive, full body rotations measured with the Torsion Swing test. Adaptation to stimulation will be evaluated through each 4-day stimulation period during the in-hospital part (with each stimulation algorithm being evaluated separately) and during selective hospital visits during the home-use part.
Measured: Through each 4-day VI stimulation period during the in-hospital part, throughout selective moments out of 13 total visits (15 months) during the home-use part
The feasibility of vestibular stimulation improving the self-movement perception in dark
Evaluating whether vestibular stimulation (via the CVI) can improve self-motion perception measured by controlled motion stimuli delivered by a moving platform. Adaptation to stimulation will be evaluated through each 4-day stimulation period with each stimulation algorithm being evaluated separately (during the in-hospital part only) and during select hospital visits during the home-use part.
Measured: Through each 4-day VI stimulation period, within 2 years after implantation, as well as at select moments out of 13 total visits (15 months) during the home-use part
The feasibility of vestibular stimulation improving gait stability and balance based on motion capture data on a treadmill
Evaluating the influence of vestibular stimulation (via the CVI) on walking patterns and stability based on motion capture data. Adaptation to stimulation will be evaluated through each 4-day stimulation period during the in-hospital part (with each stimulation algorithm being evaluated separately) and during selective hospital visits during the home-use part.
Measured: Through each 4-day VI stimulation period during the in-hospital part, throughout selective moments out of 13 total visits (15 months) during the home-use part
The feasibility of vestibular stimulation improving gait stability and balance based on motion capture data overground
Evaluating the influence of vestibular stimulation (via the CVI) on walking patterns and stability based on motion capture data. Adaptation to stimulation will be evaluated during selective hospital visits during the home-use part of the trial.
Measured: Throughout selective moments out of 13 total visits (15 months) during the home-use part, within 5 years after implantation
The feasibility of vestibular stimulation improving balance based on clinical evaluation
Clinical evaluation of the influence of vestibular stimulation (via the CVI) on balance measured with the MiniBESTest. Adaptation to stimulation will be evaluated through each 4-day stimulation period during the in-hospital part (with each stimulation algorithm being evaluated separately) and during selective hospital visits during the home-use part.
Measured: Through each 4-day VI stimulation period during the in-hospital part, throughout selective moments out of 13 total visits (15 months) during the home-use part
Speech perception with CVI in quiet without simultaneous vestibular stimulation
Evaluating hearing performance with the CVI based on speech perception in quiet measured with an aided consonant-nucleus-consonant word test, without simultaneous vestibular stimulation
Measured: Through the full trial period, until 5 years after implantation
Interaction between vestibular and cochlear stimulation on speech perception in quiet
Evaluating hearing performance with the CVI based on speech perception in quiet while simultaneously providing vestibular stimulation, measured with an aided consonant-nucleus-consonant word test. The influence of vestibular stimulation will be evaluated during the in-hospital part and home-use part of the trial.
Measured: Through each 4-day VI stimulation period during the in-hospital part, throughout selective moments out of 13 total visits (15 months) during the home-use part
Speech perception with CVI in noise without simultaneous vestibular stimulation
Evaluating hearing performance with the CVI based on speech perception in noise measured with a sentence speech In noise test, without simultaneous vestibular stimulation
Measured: Through the full trial period, until 5 years after implantation
Change in otolith function due to CVI implantation
Evaluating the influence of CVI implantation on otolith function based on cVEMP and oVEMP responses post-operatively, comparing with the pre-operative situation.
Measured: preoperatively and 1 month postoperatively
Vestibular and cochlear electrode location
Evaluating the location and potential migration of the vestibular and cochlear electrodes of the CVI with cone-beam CT scans- of the mastoid.
Measured: Through the full trial period, until 5 years after implantation
Secondary outcomes (11)
Characterization of study population on perceived dizziness
Characterizing the study population based on their perceived dizziness and the related handicap measured with the Dizziness Handicap Inventory.
Measured: Measured pre-operatively, directly before the start of the in-hospital VI stimulation period, as well as at predefined time points during the home-use period (incl. before home-use, 3-weeks, 3-months, 9-months, and after home-use)
Characterization of study population on perceived risk of falling
Characterizing the study population based on their perceived risk of falling measured with the Falls Efficacy Scale-International
Measured: Measured pre-operatively, directly before the start of the in-hospital VI stimulation period, as well as at predefined time points during the home-use period (incl. before home-use, 3-months, 9-months, and after home-use)
Characterization of study population on perceived severity of oscillopsia
Characterizing the study population based on their perceived severity of oscillopsia measured with the Oscillopsia Severity Questionnaire
Measured: Measured pre-operatively, directly before the start of the in-hospital VI stimulation period, as well as at predefined time points during the home-use period (incl. before home-use, 3-months, 9-months, and after home-use)
Subjective hearing performance of the CVI
Evaluating the subjective hearing performance of the CVI measured with the Speech and Spatial Qualities of hearing scale-12
Measured: Yearly evaluation through the full trial period, until 5 years after implantation, as well as at predefined time points during the home-use period (incl. before home-use, 3-months, 9-months, and after home-use)
Effect of CVI implantation on tinnitus burden
Evaluating the influence of CVI implantation on the subjective severity and burden of tinnitus measured with the Tinnitus Questionnaire
Measured: Pre-operatively and 1 month postoperatively, as well as at predefined time points during the home-use period (incl. before home-use, 3-months, 9-months, and after home-use)
Characterization of study population on perceived health-related quality of life
Characterizing the study population based on their perceived health-related quality of life measured with the Health Utility Index - 3
Measured: Measured pre-operatively, directly before the start of the in-hospital VI stimulation period, as well as at predefined time points during the home-use period (incl. before home-use, 3-months, 9-months, and after home-use)
Evaluating the influence of receiving and using a CVI on quality of life
Evaluating the influence of the different stages of receiving and using a CVI on quality of life measured with the EuroQOL 5 Dimensional questionnaire. Aimed at separating CI-only use and full CVI use throughout the trial to get an accurate assessment of the influence vestibulo-cochlear electrical stimulation (via the CVI) can have on quality of life
Measured: Measured directly before the start of the in-hospital VI stimulation period, as well as at predefined time points during the home-use period (incl. before home-use, 3-months, 9-months, and after home-use), until 5 years after implantation
Evaluating the influence of receiving and using a CVI on capabilities in life
Evaluating the influence of the different stages of receiving and using a CVI on capabilities in life measured with the ICEPOP Capability measure for adults. Aimed at separating CI-only use and full CVI use throughout the trial to get an accurate assessment of the influence vestibulo-cochlear electrical stimulation (via the CVI) can have on quality of life.
Measured: Measured directly before the start of the in-hospital VI stimulation period, as well as at predefined time points during the home-use period (incl. before home-use, 3-months, 9-months, and after home-use), until 5 years after implantation
Evaluating the influence of receiving and using a CVI on anxiety and depression
Evaluating the influence of the different stages of receiving and using a CVI on anxiety and depression measured with the Hospital Anxiety and Depression Scale. Aimed at separating CI-only use and full CVI use throughout the trial to get an accurate assessment of the influence vestibulo-cochlear electrical stimulation (via the CVI) can have on these aspects.
Measured: Measured directly before the start of the in-hospital VI stimulation period, as well as at predefined time points during the home-use period (incl. before home-use, 3-months, 9-months, and after home-use), until 5 years after implantation
Evaluating the daily experience with vestibular stimulation
A self-developed visual-analog scale-based list of questions for evaluating the participant's experience with the CVI on a daily basis during the prolonged stimulation period.
Measured: Through each 4-day VI stimulation period during the in-hospital part, as well as at predefined time points during the home-use period (incl. daily for the first 6 weeks of home-use).
Characterizing the participant's experience with vestibular stimulation
Semi-standardized interviews for in-depth qualitative analysis of the participant's experience with receiving vestibular stimulation (via the CVI)
Measured: Through each 4-day VI stimulation period during the in-hospital part, as well as at predefined time points during the home-use period (incl. before home-use, 3-months, 9-months, and after home-use)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2021
- Study start1 Jul 2021
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (30)Papers the sponsor has linked to this study.
- Other trials for Bilateral Vestibular LossStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Controlled clinical trial with a randomized single-blind 3-treatment 3-period crossover design during the in-hospital part. Following prolonged stimulation during the home-use part (persistency phase), there will be a short cross-over period of two treatments modes (preference phase), single-blinded, over four periods (4 weeks cross over design).
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 13 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Geneva, MED-EL Elektromedizinische Geräte GmbH, Health Holland, Heinsius-Houbolt Fund, Radboud University Medical Center, Stichting de Weijerhorst
- Responsible party
- Sponsor
- Investigators
- Raymond van de Berg, MD, PhD, Principal investigator, Maastricht UMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04918745
- Sponsor's protocol ID
- NL73492.068.20
- Other IDs
- METC20-087
- Status last verified
- Oct 2026
- First submitted
- 28 Apr 2021
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Pseudonymized data will be shared via scientific publications in open source, peer-reviewed journals. Pseudonymized data will also be available upon request (see below).
Publications
Wall C 3rd, Kos MI, Guyot JP. Eye movements in response to electric stimulation of the human posterior ampullary nerve. Ann Otol Rhinol Laryngol. 2007 May;116(5):369-74. doi: 10.1177/000348940711600509.
PubMed 17561766van de Berg R, Guinand N, Stokroos RJ, Guyot JP, Kingma H. The vestibular implant: quo vadis? Front Neurol. 2011 Aug 11;2:47. doi: 10.3389/fneur.2011.00047. eCollection 2011.
PubMed 21991260Guyot JP, Sigrist A, Pelizzone M, Kos MI. Adaptation to steady-state electrical stimulation of the vestibular system in humans. Ann Otol Rhinol Laryngol. 2011 Mar;120(3):143-9. doi: 10.1177/000348941112000301.
PubMed 21510138van de Berg R, Guinand N, Guyot JP, Kingma H, Stokroos RJ. The modified ampullar approach for vestibular implant surgery: feasibility and its first application in a human with a long-term vestibular loss. Front Neurol. 2012 Feb 20;3:18. doi: 10.3389/fneur.2012.00018. eCollection 2012.
PubMed 22363317Perez Fornos A, Guinand N, van de Berg R, Stokroos R, Micera S, Kingma H, Pelizzone M, Guyot JP. Artificial balance: restoration of the vestibulo-ocular reflex in humans with a prototype vestibular neuroprosthesis. Front Neurol. 2014 Apr 29;5:66. doi: 10.3389/fneur.2014.00066. eCollection 2014.
PubMed 24808890Nguyen TA, Ranieri M, DiGiovanna J, Peter O, Genovese V, Perez Fornos A, Micera S. A real-time research platform to study vestibular implants with gyroscopic inputs in vestibular deficient subjects. IEEE Trans Biomed Circuits Syst. 2014 Aug;8(4):474-84. doi: 10.1109/TBCAS.2013.2290089.
PubMed 25073124Pelizzone M, Fornos AP, Guinand N, van de Berg R, Kos I, Stokroos R, Kingma H, Guyot JP. First functional rehabilitation via vestibular implants. Cochlear Implants Int. 2014 May;15 Suppl 1:S62-4. doi: 10.1179/1467010014Z.000000000165. No abstract available.
PubMed 24869447van de Berg R, van Tilburg M, Kingma H. Bilateral Vestibular Hypofunction: Challenges in Establishing the Diagnosis in Adults. ORL J Otorhinolaryngol Relat Spec. 2015;77(4):197-218. doi: 10.1159/000433549. Epub 2015 Sep 15.
PubMed 26366566van de Berg R, Guinand N, Nguyen TA, Ranieri M, Cavuscens S, Guyot JP, Stokroos R, Kingma H, Perez-Fornos A. The vestibular implant: frequency-dependency of the electrically evoked vestibulo-ocular reflex in humans. Front Syst Neurosci. 2015 Jan 20;8:255. doi: 10.3389/fnsys.2014.00255. eCollection 2014.
PubMed 25653601Guinand N, van de Berg R, Cavuscens S, Stokroos RJ, Ranieri M, Pelizzone M, Kingma H, Guyot JP, Perez-Fornos A. Vestibular Implants: 8 Years of Experience with Electrical Stimulation of the Vestibular Nerve in 11 Patients with Bilateral Vestibular Loss. ORL J Otorhinolaryngol Relat Spec. 2015;77(4):227-240. doi: 10.1159/000433554. Epub 2015 Sep 15.
PubMed 26367113Guinand N, van de Berg R, Ranieri M, Cavuscens S, DiGiovanna J, Nguyen TA, Micera S, Stokroos R, Kingma H, Guyot JP, Perez Fornos A. Vestibular implants: Hope for improving the quality of life of patients with bilateral vestibular loss. Annu Int Conf IEEE Eng Med Biol Soc. 2015;2015:7192-5. doi: 10.1109/EMBC.2015.7320051.
PubMed 26737951Nguyen TA, DiGiovanna J, Cavuscens S, Ranieri M, Guinand N, van de Berg R, Carpaneto J, Kingma H, Guyot JP, Micera S, Fornos AP. Characterization of pulse amplitude and pulse rate modulation for a human vestibular implant during acute electrical stimulation. J Neural Eng. 2016 Aug;13(4):046023. doi: 10.1088/1741-2560/13/4/046023. Epub 2016 Jul 11.
PubMed 27396631DiGiovanna J, Nguyen TA, Guinand N, Perez-Fornos A, Micera S. Neural Network Model of Vestibular Nuclei Reaction to Onset of Vestibular Prosthetic Stimulation. Front Bioeng Biotechnol. 2016 Apr 20;4:34. doi: 10.3389/fbioe.2016.00034. eCollection 2016.
PubMed 27148528Guyot JP, Perez Fornos A, Guinand N, van de Berg R, Stokroos R, Kingma H. Vestibular assistance systems: promises and challenges. J Neurol. 2016 Apr;263 Suppl 1:S30-5. doi: 10.1007/s00415-015-7922-1. Epub 2016 Apr 15.
PubMed 27083882Guinand N, Van de Berg R, Cavuscens S, Stokroos R, Ranieri M, Pelizzone M, Kingma H, Guyot JP, Perez Fornos A. Restoring Visual Acuity in Dynamic Conditions with a Vestibular Implant. Front Neurosci. 2016 Dec 22;10:577. doi: 10.3389/fnins.2016.00577. eCollection 2016.
PubMed 28066163
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VertiGO! - Get up and GO! With the Vestibular Implant
- ClinicalTrials.gov ID
- NCT04918745
- Acronym / sponsor ID
- NL73492.068.20
- Conditions
- Bilateral Vestibular Loss
- Keywords
- Vestibular Implant, Cochlear vestibular implant, Bilateral vestibulopathy, Bilateral vestibular hypofunction, Bilateral vestibular loss, Cochlear implant
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 13 participants (estimated)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- University Hospital, Geneva, MED-EL Elektromedizinische Geräte GmbH, Health Holland, Heinsius-Houbolt Fund, Radboud University Medical Center, Stichting de Weijerhorst
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2029 (estimated)
- First posted
- 9 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 first be assessed using a research processor during 3 weeks (3x4 days, +- 8 hours a day) of prolonged stimulation under direct supervision in the safety of a hospital environment. This is considered the in-hospital part. Following this, a modified research processor will be used during 15 months (13 visits, half and full day) of prolonged stimulation in real-life situations under indirect supervision. This is considered the home-use part of the trial.
During the in-hospital part, 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 (1) baseline stimulation without motion modulation, (2) baseline stimulation with motion modulation, and (3) reduced baseline stimulation with motion modulation.
During the home-use part, the efficacy and safety of prolonged VI stimulation will be evaluated in a home environment using pre-post intervention evaluation. During this part, the stimulation status will alternate between VI-ON and VI-OFF, depending on the phase. The stimulation algorithm will be optimized per patients to best evaluate VI efficacy (optimization phase). Furthermore, safety and efficacy will be further elucidated by maintaining consistent prolonged VI stimulation (persistency phase), using a consistent algorithm with minimal adjustments. Following this, a resting period of at least four weeks (washout phase) will commence, where no VI stimulation will be used. This will allow for comparison between vestibular stimulation (VI-ON) versus without stimulation (VI-OFF), which aligns with the primary comparison used during the in-hospital period. In addition, this phase aims to minimize carry-over effect, ensure adequate resolution of aftereffects and evaluation of changes to quality of life. Finally, evaluation of single blinded preference between stimulation statuses will be assessed (preference phase). Patients will have the option to continue using vestibular stimulation after the preference phase for as long as the trial continues (resume phase).
Alongside the periods 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 design
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 12
- Model description
- Controlled clinical trial with a randomized single-blind 3-treatment 3-period crossover design during the in-hospital part. Following prolonged stimulation during the home-use part (persistency phase), there will be a short cross-over period of two treatments modes (preference phase), single-blinded, over four periods (4 weeks cross over design).
| Arm | Type | Receives |
|---|---|---|
| ABC | Other | Device: Cochlear Vestibular Implant (CVI) - in-hosptialIn-hospital part A = Baseline stimulation, no modulation B = Baseline stimulation, modulation stimulation C = Reduced baseline stimulation, modulation stimulation |
| ACB | Other | Device: Cochlear Vestibular Implant (CVI) - in-hosptialIn-hospital part A = Baseline stimulation, no modulation C = Reduced baseline stimulation, modulation stimulation B = Baseline stimulation, modulation stimulation |
| BAC | Other | Device: Cochlear Vestibular Implant (CVI) - in-hosptialIn-hospital part B = Baseline stimulation, modulation stimulation A = Baseline stimulation, no modulation C = Reduced baseline stimulation, modulation stimulation |
| BCA | Other | Device: Cochlear Vestibular Implant (CVI) - in-hosptialIn-hospital part B = Baseline stimulation, modulation stimulation C = Reduced baseline stimulation, modulation stimulation A = Baseline stimulation, no modulation |
| CAB | Other | Device: Cochlear Vestibular Implant (CVI) - in-hosptialIn-hospital part C = Reduced baseline stimulation, modulation stimulation A = Baseline stimulation, no modulation B = Baseline stimulation, modulation stimulation |
| CBA | Other | Device: Cochlear Vestibular Implant (CVI) - in-hosptialIn-hospital part C = Reduced baseline stimulation, modulation stimulation B = Baseline stimulation, modulation stimulation A = Baseline stimulation, no modulation |
| 1122 | Other | Device: Cochlear Vestibular Implant (CVI) - home-use (preference)Home-use part, preference phase 1. - Stimulation Mode 1, 2. - Stimulation Mode 2 |
| 1212 | Other | Device: Cochlear Vestibular Implant (CVI) - home-use (preference)Home-use part, preference phase 1. - Stimulation Mode 1, 2. - Stimulation Mode 2 |
| 1221 | Other | Device: Cochlear Vestibular Implant (CVI) - home-use (preference)Home-use part, preference phase 1. - Stimulation Mode 1, 2. - Stimulation Mode 2 |
| 2211 | Other | Device: Cochlear Vestibular Implant (CVI) - home-use (preference)Home-use part, preference phase 1. - Stimulation Mode 1, 2. - Stimulation Mode 2 |
| 2121 | Other | Device: Cochlear Vestibular Implant (CVI) - home-use (preference)Home-use part, preference phase 1. - Stimulation Mode 1, 2. - Stimulation Mode 2 |
| 2112 | Other | Device: Cochlear Vestibular Implant (CVI) - home-use (preference)Home-use part, preference phase 1. - Stimulation Mode 1, 2. - Stimulation Mode 2 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Chronic vestibular syndrome being presented by disabling symptoms of postural imbalance and/or impaired image stabilization (e.g. oscillopsia)
- 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)
- Onset of bilateral vestibular loss after the age of 2
Key exclusion criteria (15 listed)
- Signs of central vestibular/cochlear dysfunction or structural vestibular/cochlear nerve pathology (judged by physical examination / MRI)
- Clear signs of structural nerve pathology or indications of improperly functioning vestibular/cochlear nerves
- Requirement for electric-acoustic activation of the CI part (e.g. "hybrid" processor) prior to completion of the prolonged VI stimulation period
- Having received a cochlear implant earlier on the side to implant (e.g. explantation/reimplantation)
- Having received a cochlear implant from another brand than MED-EL in the other ear (bilateral implantation with different brands is not supported)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cochlear Vestibular Implant (CVI) - in-hosptialThe 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. During the in-hospital part, three vestibular stimulation algorithms will be compared in a randomized order (3 treatments x 3 periods, = 6 arms). These stimulation algorithms are: * A - Baseline stimulation, no modulation stimulation * B - Baseline stimulation, modulated stimulation * C - Reduced baseline stimulation, modulated stimulation | Device | ABC, ACB, BAC, BCA, CAB, CBA |
| Cochlear Vestibular Implant (CVI) - home-use (preference)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. During the home-use part, a preference phase will be included to assess the effects of a "control". Participants will receive two research processors, each with a different vestibular stimulation mode. These modes will be randomized over a 4-week period, each appearing twice (2 treatments appearing twice each x 4 weeks = 6 arms). These stimulation modes are: * 1: Stimulation Mode 1 * 2: Stimulation Mode 2 | Device | 1122, 1212, 1221, 2112, 2121, 2211 |
Primary outcome
Safety of vestibular stimulation via the CVI
Time frame: Through full trial period, or up to 5 years postoperatively
Amount of (S)AE's after implantation to determine safety of the device
The feasibility of vestibular stimulation improving Dynamic Visual Acuity during walking
Time frame: Through all stimulation periods, within 5 years after implantation
Quantifying vestibulo-ocular reflex restoration on a functional level by evaluating the capacity of vestibular stimulation (via the CVI) to improve dynamic visual acuity while walking. Adaptation to stimulation will be evaluated through each 4-day stimulation period during the in-hospital part (with each stimulation algorithm being evaluated separately) and during each hospital visit during the home-use part.
The feasibility of vestibular stimulation improving Dynamic Visual Acuity during passive head movements
Time frame: Through each 4-day VI stimulation period during the in-hospital part, throughout selective moments out of 13 total visits (15 months) during the home-use part
Quantifying vestibulo-ocular reflex restoration on a functional level by evaluating the capacity of vestibular stimulation (via the CVI) to improve dynamic visual acuity during fast passive head movements measured with the functional Head Impulse Test. Adaptation to stimulation will be evaluated through each 4-day stimulation period during the in-hospital part (with each stimulation algorithm being evaluated separately) and during each hospital visit during the home-use part.
The feasibility of vestibular stimulation restoring the high-frequency vestibulo-ocular reflex
Time frame: Through each 4-day VI stimulation period during the in-hospital part, throughout selective moments out of 13 total visits (15 months) during the home-use part
Evaluating the capacity of vestibular stimulation (via the CVI) to increase vestibulo-ocular reflex gain during fast passive head movements in the LHRH, RALP and LARP planes measured with the video Head Impulse Test. Adaptation to stimulation will be evaluated through each 4-day stimulation period during the in-hospital part (with each stimulation algorithm being evaluated separately) and during each hospital visit during the home-use part.
The feasibility of vestibular stimulation restoring the low-frequency vestibulo-ocular reflex
Time frame: Through each 4-day VI stimulation period during the in-hospital part, throughout selective moments out of 13 total visits (15 months) during the home-use part
Evaluating the capacity of vestibular stimulation (via the CVI) to increase vestibulo-ocular reflex gain during slow, passive, full body rotations measured with the Torsion Swing test. Adaptation to stimulation will be evaluated through each 4-day stimulation period during the in-hospital part (with each stimulation algorithm being evaluated separately) and during selective hospital visits during the home-use part.
The feasibility of vestibular stimulation improving the self-movement perception in dark
Time frame: Through each 4-day VI stimulation period, within 2 years after implantation, as well as at select moments out of 13 total visits (15 months) during the home-use part
Evaluating whether vestibular stimulation (via the CVI) can improve self-motion perception measured by controlled motion stimuli delivered by a moving platform. Adaptation to stimulation will be evaluated through each 4-day stimulation period with each stimulation algorithm being evaluated separately (during the in-hospital part only) and during select hospital visits during the home-use part.
The feasibility of vestibular stimulation improving gait stability and balance based on motion capture data on a treadmill
Time frame: Through each 4-day VI stimulation period during the in-hospital part, throughout selective moments out of 13 total visits (15 months) during the home-use part
Evaluating the influence of vestibular stimulation (via the CVI) on walking patterns and stability based on motion capture data. Adaptation to stimulation will be evaluated through each 4-day stimulation period during the in-hospital part (with each stimulation algorithm being evaluated separately) and during selective hospital visits during the home-use part.
The feasibility of vestibular stimulation improving gait stability and balance based on motion capture data overground
Time frame: Throughout selective moments out of 13 total visits (15 months) during the home-use part, within 5 years after implantation
Evaluating the influence of vestibular stimulation (via the CVI) on walking patterns and stability based on motion capture data. Adaptation to stimulation will be evaluated during selective hospital visits during the home-use part of the trial.
The feasibility of vestibular stimulation improving balance based on clinical evaluation
Time frame: Through each 4-day VI stimulation period during the in-hospital part, throughout selective moments out of 13 total visits (15 months) during the home-use part
Clinical evaluation of the influence of vestibular stimulation (via the CVI) on balance measured with the MiniBESTest. Adaptation to stimulation will be evaluated through each 4-day stimulation period during the in-hospital part (with each stimulation algorithm being evaluated separately) and during selective hospital visits during the home-use part.
Speech perception with CVI in quiet without simultaneous vestibular stimulation
Time frame: Through the full trial period, until 5 years after implantation
Evaluating hearing performance with the CVI based on speech perception in quiet measured with an aided consonant-nucleus-consonant word test, without simultaneous vestibular stimulation
Interaction between vestibular and cochlear stimulation on speech perception in quiet
Time frame: Through each 4-day VI stimulation period during the in-hospital part, throughout selective moments out of 13 total visits (15 months) during the home-use part
Evaluating hearing performance with the CVI based on speech perception in quiet while simultaneously providing vestibular stimulation, measured with an aided consonant-nucleus-consonant word test. The influence of vestibular stimulation will be evaluated during the in-hospital part and home-use part of the trial.
Speech perception with CVI in noise without simultaneous vestibular stimulation
Time frame: Through the full trial period, until 5 years after implantation
Evaluating hearing performance with the CVI based on speech perception in noise measured with a sentence speech In noise test, without simultaneous vestibular stimulation
Change in otolith function due to CVI implantation
Time frame: preoperatively and 1 month postoperatively
Evaluating the influence of CVI implantation on otolith function based on cVEMP and oVEMP responses post-operatively, comparing with the pre-operative situation.
Vestibular and cochlear electrode location
Time frame: Through the full trial period, until 5 years after implantation
Evaluating the location and potential migration of the vestibular and cochlear electrodes of the CVI with cone-beam CT scans- of the mastoid.
11 secondary outcomes
Characterization of study population on perceived dizziness
Time frame: Measured pre-operatively, directly before the start of the in-hospital VI stimulation period, as well as at predefined time points during the home-use period (incl. before home-use, 3-weeks, 3-months, 9-months, and after home-use)
Characterization of study population on perceived risk of falling
Time frame: Measured pre-operatively, directly before the start of the in-hospital VI stimulation period, as well as at predefined time points during the home-use period (incl. before home-use, 3-months, 9-months, and after home-use)
Characterization of study population on perceived severity of oscillopsia
Time frame: Measured pre-operatively, directly before the start of the in-hospital VI stimulation period, as well as at predefined time points during the home-use period (incl. before home-use, 3-months, 9-months, and after home-use)
Subjective hearing performance of the CVI
Time frame: Yearly evaluation through the full trial period, until 5 years after implantation, as well as at predefined time points during the home-use period (incl. before home-use, 3-months, 9-months, and after home-use)
Effect of CVI implantation on tinnitus burden
Time frame: Pre-operatively and 1 month postoperatively, as well as at predefined time points during the home-use period (incl. before home-use, 3-months, 9-months, and after home-use)
Characterization of study population on perceived health-related quality of life
Time frame: Measured pre-operatively, directly before the start of the in-hospital VI stimulation period, as well as at predefined time points during the home-use period (incl. before home-use, 3-months, 9-months, and after home-use)
Evaluating the influence of receiving and using a CVI on quality of life
Time frame: Measured directly before the start of the in-hospital VI stimulation period, as well as at predefined time points during the home-use period (incl. before home-use, 3-months, 9-months, and after home-use), until 5 years after implantation
Evaluating the influence of receiving and using a CVI on capabilities in life
Time frame: Measured directly before the start of the in-hospital VI stimulation period, as well as at predefined time points during the home-use period (incl. before home-use, 3-months, 9-months, and after home-use), until 5 years after implantation
Evaluating the influence of receiving and using a CVI on anxiety and depression
Time frame: Measured directly before the start of the in-hospital VI stimulation period, as well as at predefined time points during the home-use period (incl. before home-use, 3-months, 9-months, and after home-use), until 5 years after implantation
Evaluating the daily experience with vestibular stimulation
Time frame: Through each 4-day VI stimulation period during the in-hospital part, as well as at predefined time points during the home-use period (incl. daily for the first 6 weeks of home-use).
Characterizing the participant's experience with vestibular stimulation
Time frame: Through each 4-day VI stimulation period during the in-hospital part, as well as at predefined time points during the home-use period (incl. before home-use, 3-months, 9-months, and after home-use)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Background: PubMed 17561766Wall C 3rd, Kos MI, Guyot JP. Eye movements in response to electric stimulation of the human posterior ampullary nerve. Ann Otol Rhinol Laryngol. 2007 May;116(5):369-74. doi: 10.1177/000348940711600509.
- Background: PubMed 21991260van de Berg R, Guinand N, Stokroos RJ, Guyot JP, Kingma H. The vestibular implant: quo vadis? Front Neurol. 2011 Aug 11;2:47. doi: 10.3389/fneur.2011.00047. eCollection 2011.
- Background: PubMed 21510138Guyot JP, Sigrist A, Pelizzone M, Kos MI. Adaptation to steady-state electrical stimulation of the vestibular system in humans. Ann Otol Rhinol Laryngol. 2011 Mar;120(3):143-9. doi: 10.1177/000348941112000301.
- Background: PubMed 22363317van de Berg R, Guinand N, Guyot JP, Kingma H, Stokroos RJ. The modified ampullar approach for vestibular implant surgery: feasibility and its first application in a human with a long-term vestibular loss. Front Neurol. 2012 Feb 20;3:18. doi: 10.3389/fneur.2012.00018. eCollection 2012.
- Background: PubMed 24808890Perez Fornos A, Guinand N, van de Berg R, Stokroos R, Micera S, Kingma H, Pelizzone M, Guyot JP. Artificial balance: restoration of the vestibulo-ocular reflex in humans with a prototype vestibular neuroprosthesis. Front Neurol. 2014 Apr 29;5:66. doi: 10.3389/fneur.2014.00066. eCollection 2014.
- Background: PubMed 25073124Nguyen TA, Ranieri M, DiGiovanna J, Peter O, Genovese V, Perez Fornos A, Micera S. A real-time research platform to study vestibular implants with gyroscopic inputs in vestibular deficient subjects. IEEE Trans Biomed Circuits Syst. 2014 Aug;8(4):474-84. doi: 10.1109/TBCAS.2013.2290089.
- Background: PubMed 24869447Pelizzone M, Fornos AP, Guinand N, van de Berg R, Kos I, Stokroos R, Kingma H, Guyot JP. First functional rehabilitation via vestibular implants. Cochlear Implants Int. 2014 May;15 Suppl 1:S62-4. doi: 10.1179/1467010014Z.000000000165. No abstract available.
- Background: PubMed 26366566van de Berg R, van Tilburg M, Kingma H. Bilateral Vestibular Hypofunction: Challenges in Establishing the Diagnosis in Adults. ORL J Otorhinolaryngol Relat Spec. 2015;77(4):197-218. doi: 10.1159/000433549. Epub 2015 Sep 15.
- Background: PubMed 25653601van de Berg R, Guinand N, Nguyen TA, Ranieri M, Cavuscens S, Guyot JP, Stokroos R, Kingma H, Perez-Fornos A. The vestibular implant: frequency-dependency of the electrically evoked vestibulo-ocular reflex in humans. Front Syst Neurosci. 2015 Jan 20;8:255. doi: 10.3389/fnsys.2014.00255. eCollection 2014.
- Background: PubMed 26367113Guinand N, van de Berg R, Cavuscens S, Stokroos RJ, Ranieri M, Pelizzone M, Kingma H, Guyot JP, Perez-Fornos A. Vestibular Implants: 8 Years of Experience with Electrical Stimulation of the Vestibular Nerve in 11 Patients with Bilateral Vestibular Loss. ORL J Otorhinolaryngol Relat Spec. 2015;77(4):227-240. doi: 10.1159/000433554. Epub 2015 Sep 15.
- Background: PubMed 26737951Guinand N, van de Berg R, Ranieri M, Cavuscens S, DiGiovanna J, Nguyen TA, Micera S, Stokroos R, Kingma H, Guyot JP, Perez Fornos A. Vestibular implants: Hope for improving the quality of life of patients with bilateral vestibular loss. Annu Int Conf IEEE Eng Med Biol Soc. 2015;2015:7192-5. doi: 10.1109/EMBC.2015.7320051.
- Background: PubMed 27396631Nguyen TA, DiGiovanna J, Cavuscens S, Ranieri M, Guinand N, van de Berg R, Carpaneto J, Kingma H, Guyot JP, Micera S, Fornos AP. Characterization of pulse amplitude and pulse rate modulation for a human vestibular implant during acute electrical stimulation. J Neural Eng. 2016 Aug;13(4):046023. doi: 10.1088/1741-2560/13/4/046023. Epub 2016 Jul 11.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Pseudonymized data will be shared via scientific publications in open source, peer-reviewed journals. Pseudonymized data will also be available upon request (see below).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raymond van de Berg, MD, PhD principal investigator
Maastricht UMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cochlear Vestibular Implant (CVI) - in-hosptial and Cochlear Vestibular Implant (CVI) - home-use (preference) in people with Bilateral Vestibular Loss, run by Maastricht University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of vestibular stimulation via the CVI (time frame: Through full trial period, or up to 5 years postoperatively). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04918745, which also lists 30 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.