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

NCT ID: NCT04918745

Last Updated: 2026-01-16

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-01
• Study Completion Date: 2029-06-30

Brief 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). 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.

Conditions

Bilateral Vestibular Loss

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: SINGLE

Study Groups

ABC

In-hospital part

A = Baseline stimulation, no modulation

B = Baseline stimulation, modulation stimulation

C = Reduced baseline stimulation, modulation stimulation

Group Type: OTHER

Cochlear Vestibular Implant (CVI)

Intervention Type: 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 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

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 - individualized vestibular stimulation
• 2 - control vestibular stimulation

ACB

In-hospital part

A = Baseline stimulation, no modulation

C = Reduced baseline stimulation, modulation stimulation

B = Baseline stimulation, modulation stimulation

Group Type: OTHER

Cochlear Vestibular Implant (CVI)

Intervention Type: 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 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

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 - individualized vestibular stimulation
• 2 - control vestibular stimulation

BAC

In-hospital part

B = Baseline stimulation, modulation stimulation

A = Baseline stimulation, no modulation

C = Reduced baseline stimulation, modulation stimulation

Group Type: OTHER

Cochlear Vestibular Implant (CVI)

Intervention Type: 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 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

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 - individualized vestibular stimulation
• 2 - control vestibular stimulation

BCA

In-hospital part

B = Baseline stimulation, modulation stimulation

C = Reduced baseline stimulation, modulation stimulation

A = Baseline stimulation, no modulation

Group Type: OTHER

Cochlear Vestibular Implant (CVI)

Intervention Type: 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 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

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 - individualized vestibular stimulation
• 2 - control vestibular stimulation

CAB

In-hospital part

C = Reduced baseline stimulation, modulation stimulation

A = Baseline stimulation, no modulation

B = Baseline stimulation, modulation stimulation

Group Type: OTHER

Cochlear Vestibular Implant (CVI)

Intervention Type: 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 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

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 - individualized vestibular stimulation
• 2 - control vestibular stimulation

CBA

In-hospital part

C = Reduced baseline stimulation, modulation stimulation

B = Baseline stimulation, modulation stimulation

A = Baseline stimulation, no modulation

Group Type: OTHER

Cochlear Vestibular Implant (CVI)

Intervention Type: 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 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

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 - individualized vestibular stimulation
• 2 - control vestibular stimulation

1122

Home-use part, preference phase

1. - individualized vestibular stimulation

2. - control vestibular stimulation

Group Type: OTHER

Cochlear Vestibular Implant (CVI)

Intervention Type: 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 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

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 - individualized vestibular stimulation
• 2 - control vestibular stimulation

1212

Home-use part, preference phase

1. - individualized vestibular stimulation

2. - control vestibular stimulation

Group Type: OTHER

Cochlear Vestibular Implant (CVI)

Intervention Type: 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 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

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 - individualized vestibular stimulation
• 2 - control vestibular stimulation

1221

Home-use part, preference phase

1. - individualized vestibular stimulation

2. - control vestibular stimulation

Group Type: OTHER

Cochlear Vestibular Implant (CVI)

Intervention Type: 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 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

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 - individualized vestibular stimulation
• 2 - control vestibular stimulation

2211

Home-use part, preference phase

1. - individualized vestibular stimulation

2. - control vestibular stimulation

Group Type: OTHER

Cochlear Vestibular Implant (CVI)

Intervention Type: 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 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

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 - individualized vestibular stimulation
• 2 - control vestibular stimulation

2121

Home-use part, preference phase

1. - individualized vestibular stimulation

2. - control vestibular stimulation

Group Type: OTHER

Cochlear Vestibular Implant (CVI)

Intervention Type: 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 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

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 - individualized vestibular stimulation
• 2 - control vestibular stimulation

2112

Home-use part, preference phase

1. - individualized vestibular stimulation

2. - control vestibular stimulation

Group Type: OTHER

Cochlear Vestibular Implant (CVI)

Intervention Type: 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 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

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 - individualized vestibular stimulation
• 2 - control vestibular stimulation

Interventions

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.

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

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 - individualized vestibular stimulation
• 2 - control vestibular stimulation

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Chronic vestibular syndrome being presented by disabling symptoms of postural imbalance and/or impaired image stabilization (e.g. oscillopsia)

2. 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)

3. Onset of bilateral vestibular loss after the age of 2

4. Vestibular dysfunction from a peripheral origin or idiopathic BV

5. Patent vestibular end-organ (judged by CT)

7. Meeting CI-candidacy in ear to implant with CVI

8. Agreed to receive a MED-EL CVI implant with MED-EL sound processor

9. Capacitated adults ≥ 18 years

10. Proficient speaker of the Dutch language

11. No contra-indications for CVI surgery

12. 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

13. 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.

Exclusion Criteria

1. Signs of central vestibular/cochlear dysfunction or structural vestibular/cochlear nerve pathology (judged by physical examination / MRI)

2. Clear signs of structural nerve pathology or indications of improperly functioning vestibular/cochlear nerves

3. Requirement for electric-acoustic activation of the CI part (e.g. "hybrid" processor) prior to completion of the prolonged VI stimulation period

4. Having received a cochlear implant earlier on the side to implant (e.g. explantation/reimplantation)

5. Having received a cochlear implant from another brand than MED-EL in the other ear (bilateral implantation with different brands is not supported)

6. 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.

7. Pre-lingual onset of bilateral profound deafness (< 4 years of age)

8. Active participation in another prospective clinical trial

9. Pregnancy or having plans to become pregnant at the time of imaging or during the VI trial

10. Orthopedic, ocular, neurologic or other non-vestibular pathologic conditions of sufficient severity to confound vestibular function tests used in the study

11. Current psychological or psychiatric disorders that could significantly interfere with the use or evaluation of VI stimulation

12. Physical or non-physical contraindications for MRI or CT imaging prior to surgery

13. Making chronic use of psychiatric medication which suppresses VOR responses (e.g. SSRI's, benzodiazepines)

14. Significant dental problems which prohibit the stable use of a 'bite bar' (used as calibration reference for the gyroscope functionality of the CVI)

15. Any medical condition, judged by the research team, that is likely to interfere with a study candidate's participation in the study

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Geneva

OTHER

Sponsor Role: collaborator

MED-EL Elektromedizinische Geräte GesmbH

INDUSTRY

Sponsor Role: collaborator

Health Holland

OTHER

Sponsor Role: collaborator

Heinsius-Houbolt Fund

UNKNOWN

Sponsor Role: collaborator

Radboud University Medical Center

OTHER

Sponsor Role: collaborator

Stichting de Weijerhorst

UNKNOWN

Sponsor Role: collaborator

Maastricht University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Raymond van de Berg, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Maastricht UMC

Locations

Maastricht UMC+

Maastricht, Limburg, Netherlands

Countries

Netherlands

References

Guyot 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.

Reference Type: BACKGROUND

PMID: 21510138 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17561766 (View on PubMed)

van 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.

Reference Type: BACKGROUND

PMID: 21991260 (View on PubMed)

van 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.

Reference Type: BACKGROUND

PMID: 22363317 (View on PubMed)

Perez 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.

Reference Type: BACKGROUND

PMID: 24808890 (View on PubMed)

Nguyen 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.

Reference Type: BACKGROUND

PMID: 25073124 (View on PubMed)

Pelizzone 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.

Reference Type: BACKGROUND

PMID: 24869447 (View on PubMed)

van 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.

Reference Type: BACKGROUND

PMID: 26366566 (View on PubMed)

van 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.

Reference Type: BACKGROUND

PMID: 25653601 (View on PubMed)

Guinand 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.

Reference Type: BACKGROUND

PMID: 26367113 (View on PubMed)

Guinand 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.

Reference Type: BACKGROUND

PMID: 26737951 (View on PubMed)

Nguyen 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.

Reference Type: BACKGROUND

PMID: 27396631 (View on PubMed)

DiGiovanna 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.

Reference Type: BACKGROUND

PMID: 27148528 (View on PubMed)

Guyot 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.

Reference Type: BACKGROUND

PMID: 27083882 (View on PubMed)

Guinand 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.

Reference Type: BACKGROUND

PMID: 28066163 (View on PubMed)

Nguyen TAK, Cavuscens S, Ranieri M, Schwarz K, Guinand N, van de Berg R, van den Boogert T, Lucieer F, van Hoof M, Guyot JP, Kingma H, Micera S, Perez Fornos A. Characterization of Cochlear, Vestibular and Cochlear-Vestibular Electrically Evoked Compound Action Potentials in Patients with a Vestibulo-Cochlear Implant. Front Neurosci. 2017 Nov 21;11:645. doi: 10.3389/fnins.2017.00645. eCollection 2017.

Reference Type: BACKGROUND

PMID: 29209162 (View on PubMed)

Guinand N, Van de Berg R, Cavuscens S, Ranieri M, Schneider E, Lucieer F, Kingma H, Guyot JP, Perez Fornos A. The Video Head Impulse Test to Assess the Efficacy of Vestibular Implants in Humans. Front Neurol. 2017 Nov 14;8:600. doi: 10.3389/fneur.2017.00600. eCollection 2017.

Reference Type: BACKGROUND

PMID: 29184530 (View on PubMed)

van de Berg R, Guinand N, Ranieri M, Cavuscens S, Khoa Nguyen TA, Guyot JP, Lucieer F, Starkov D, Kingma H, van Hoof M, Perez-Fornos A. The Vestibular Implant Input Interacts with Residual Natural Function. Front Neurol. 2017 Dec 14;8:644. doi: 10.3389/fneur.2017.00644. eCollection 2017.

Reference Type: BACKGROUND

PMID: 29312107 (View on PubMed)

Perez Fornos A, Cavuscens S, Ranieri M, van de Berg R, Stokroos R, Kingma H, Guyot JP, Guinand N. The vestibular implant: A probe in orbit around the human balance system. J Vestib Res. 2017;27(1):51-61. doi: 10.3233/VES-170604.

Reference Type: BACKGROUND

PMID: 28387690 (View on PubMed)

van de Berg R, Lucieer F, Guinand N, van Tongeren J, George E, Guyot JP, Kingma H, van Hoof M, Temel Y, van Overbeeke J, Perez-Fornos A, Stokroos R. The Vestibular Implant: Hearing Preservation during Intralabyrinthine Electrode Insertion-A Case Report. Front Neurol. 2017 Apr 10;8:137. doi: 10.3389/fneur.2017.00137. eCollection 2017.

Reference Type: BACKGROUND

PMID: 28443060 (View on PubMed)

Fornos AP, van de Berg R, Armand S, Cavuscens S, Ranieri M, Cretallaz C, Kingma H, Guyot JP, Guinand N. Cervical myogenic potentials and controlled postural responses elicited by a prototype vestibular implant. J Neurol. 2019 Sep;266(Suppl 1):33-41. doi: 10.1007/s00415-019-09491-x. Epub 2019 Aug 8.

Reference Type: BACKGROUND

PMID: 31396689 (View on PubMed)

Guyot JP, Perez Fornos A. Milestones in the development of a vestibular implant. Curr Opin Neurol. 2019 Feb;32(1):145-153. doi: 10.1097/WCO.0000000000000639.

Reference Type: BACKGROUND

PMID: 30566413 (View on PubMed)

Starkov D, Guinand N, Lucieer F, Ranieri M, Cavuscens S, Pleshkov M, Guyot JP, Kingma H, Ramat S, Perez-Fornos A, van de Berg R. Restoring the High-Frequency Dynamic Visual Acuity with a Vestibular Implant Prototype in Humans. Audiol Neurootol. 2020;25(1-2):91-95. doi: 10.1159/000503677. Epub 2019 Oct 29.

Reference Type: BACKGROUND

PMID: 31661687 (View on PubMed)

Seppen BF, van Hoof M, Stultiens JJA, van den Boogert T, Guinand N, Guyot JP, Kingma H, Fornos AP, Handschuh S, Glueckert R, Jacobi L, Schrott-Fischer A, Johnson Chacko L, van de Berg R. Drafting a Surgical Procedure Using a Computational Anatomy Driven Approach for Precise, Robust, and Safe Vestibular Neuroprosthesis Placement-When One Size Does Not Fit All. Otol Neurotol. 2019 Jun;40(5S Suppl 1):S51-S58. doi: 10.1097/MAO.0000000000002211.

Reference Type: BACKGROUND

PMID: 31225823 (View on PubMed)

Stultiens JJA, Postma AA, Guinand N, Perez Fornos A, Kingma H, van de Berg R. Vestibular Implantation and the Feasibility of Fluoroscopy-Guided Electrode Insertion. Otolaryngol Clin North Am. 2020 Feb;53(1):115-126. doi: 10.1016/j.otc.2019.09.006. Epub 2019 Oct 31.

Reference Type: BACKGROUND

PMID: 31677739 (View on PubMed)

Cretallaz C, Boutabla A, Cavuscens S, Ranieri M, Nguyen TAK, Kingma H, Van De Berg R, Guinand N, Perez Fornos A. Influence of systematic variations of the stimulation profile on responses evoked with a vestibular implant prototype in humans. J Neural Eng. 2020 Jun 12;17(3):036027. doi: 10.1088/1741-2552/ab8342.

Reference Type: BACKGROUND

PMID: 32213673 (View on PubMed)

van de Berg R, Ramos A, van Rompaey V, Bisdorff A, Perez-Fornos A, Rubinstein JT, Phillips JO, Strupp M, Della Santina CC, Guinand N. The vestibular implant: Opinion statement on implantation criteria for research. J Vestib Res. 2020;30(3):213-223. doi: 10.3233/VES-200701.

Reference Type: BACKGROUND

PMID: 32651339 (View on PubMed)

van Boxel SCJ, Vermorken BL, Volpe B, Guinand N, Perez-Fornos A, Devocht EMJ, van de Berg R. Vestibular implant stimulation: pulse amplitude modulation versus combined pulse rate and amplitude modulation. J Neural Eng. 2025 Mar 28;22(2). doi: 10.1088/1741-2552/adc33a.

Reference Type: DERIVED

PMID: 40112351 (View on PubMed)

Vermorken BL, van Boxel SCJ, Volpe B, Guinand N, Perez Fornos A, Devocht EMJ, van de Berg R. Rapid acclimatization to baseline stimulation with a multi-canal vestibulocochlear implant. Eur Arch Otorhinolaryngol. 2025 Jun;282(6):2991-3003. doi: 10.1007/s00405-024-09184-w. Epub 2025 Jan 30.

Reference Type: DERIVED

PMID: 39885011 (View on PubMed)

Vermorken BL, Volpe B, van Boxel SCJ, Stultiens JJA, van Hoof M, Marcellis R, Loos E, van Soest A, McCrum C, Meijer K, Guinand N, Perez Fornos A, van Rompaey V, Devocht E, van de Berg R. The VertiGO! Trial protocol: A prospective, single-center, patient-blinded study to evaluate efficacy and safety of prolonged daily stimulation with a multichannel vestibulocochlear implant prototype in bilateral vestibulopathy patients. PLoS One. 2024 Mar 28;19(3):e0301032. doi: 10.1371/journal.pone.0301032. eCollection 2024.

Reference Type: DERIVED

PMID: 38547135 (View on PubMed)

Related Links

http://www.vestibularimplant.com

Related Info

Other Identifiers

METC20-087

Identifier Type: OTHER

Identifier Source: secondary_id

NL73492.068.20

Identifier Type: -

Identifier Source: org_study_id