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

NCT04918745 | Active Not Recruiting DMC

• 2 other identifiers: NL73492.068.20METC20-087
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Bilateral Vestibular Loss

Keywords

Vestibular Implant; Cochlear vestibular implant; Bilateral vestibulopathy; Bilateral vestibular hypofunction; Bilateral vestibular loss; Cochlear implant

Outcome Measures

Primary Outcomes (14)

• Safety of vestibular stimulation via the CVI

  Amount of (S)AE's after implantation to determine safety of the device

  Through full trial period, 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 vestibular stimulation will be evaluated through the in-hospital and home-use parts.

  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 with each stimulation algorithm being evaluated separately.

  Through each 4-day VI stimulation period, within 2 years after implantation

• 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 with each stimulation algorithm being evaluated separately.

  Through each 4-day VI stimulation period, within 2 years after implantation

• 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 with each stimulation algorithm being evaluated separately.

  Through each 4-day VI stimulation period, within 2 years after implantation

• 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.

  Through each 4-day VI stimulation period, within 2 years after implantation

• 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 with each stimulation algorithm being evaluated separately.

  Through each 4-day VI stimulation period, within 2 years after implantation

• 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 vestibular stimulation will be evaluated through each phase during the home-use part of the trial.

  Through each home-use phase, 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 with each stimulation algorithm being evaluated separately.

  Through each 4-day VI stimulation period, within 2 years after implantation

• 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

  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 each vestibular stimulation algorithm will be evaluated separately.

  Through each 4-day VI stimulation period, within 2 years after implantation

• 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

  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.

  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.

  Through the full trial period, until 5 years after implantation

Secondary Outcomes (11)

• Characterization of study population on perceived dizziness

  Measured pre-operatively and directly before the start of the VI stimulation period

• Characterization of study population on perceived risk of falling

  Measured pre-operatively and directly before the start of the VI stimulation period

• Characterization of study population on perceived severity of oscillopsia

  Measured pre-operatively and directly before the start of the VI stimulation period

• Subjective hearing performance of the CVI

  Yearly evaluation through the full trial period, until 5 years after implantation

• Effect of CVI implantation on tinnitus burden

  Pre-operatively and 1 month postoperatively

Study Arms (12)

ABC

OTHER

In-hospital part A = Baseline stimulation, no modulation B = Baseline stimulation, modulation stimulation C = Reduced baseline stimulation, modulation stimulation

Device: Cochlear Vestibular Implant (CVI)

ACB

OTHER

In-hospital part A = Baseline stimulation, no modulation C = Reduced baseline stimulation, modulation stimulation B = Baseline stimulation, modulation stimulation

Device: Cochlear Vestibular Implant (CVI)

BAC

OTHER

In-hospital part B = Baseline stimulation, modulation stimulation A = Baseline stimulation, no modulation C = Reduced baseline stimulation, modulation stimulation

Device: Cochlear Vestibular Implant (CVI)

BCA

OTHER

In-hospital part B = Baseline stimulation, modulation stimulation C = Reduced baseline stimulation, modulation stimulation A = Baseline stimulation, no modulation

Device: Cochlear Vestibular Implant (CVI)

CAB

OTHER

In-hospital part C = Reduced baseline stimulation, modulation stimulation A = Baseline stimulation, no modulation B = Baseline stimulation, modulation stimulation

Device: Cochlear Vestibular Implant (CVI)

CBA

OTHER

In-hospital part C = Reduced baseline stimulation, modulation stimulation B = Baseline stimulation, modulation stimulation A = Baseline stimulation, no modulation

Device: Cochlear Vestibular Implant (CVI)

1122

OTHER

Home-use part, preference phase 1. \- individualized vestibular stimulation 2. \- control vestibular stimulation

Device: Cochlear Vestibular Implant (CVI)

1212

OTHER

Home-use part, preference phase 1. \- individualized vestibular stimulation 2. \- control vestibular stimulation

Device: Cochlear Vestibular Implant (CVI)

1221

OTHER

Home-use part, preference phase 1. \- individualized vestibular stimulation 2. \- control vestibular stimulation

Device: Cochlear Vestibular Implant (CVI)

2211

OTHER

Home-use part, preference phase 1. \- individualized vestibular stimulation 2. \- control vestibular stimulation

Device: Cochlear Vestibular Implant (CVI)

2121

OTHER

Home-use part, preference phase 1. \- individualized vestibular stimulation 2. \- control vestibular stimulation

Device: Cochlear Vestibular Implant (CVI)

2112

OTHER

Home-use part, preference phase 1. \- individualized vestibular stimulation 2. \- control vestibular stimulation

Device: Cochlear Vestibular Implant (CVI)

Interventions

Cochlear Vestibular Implant (CVI) 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; 1212; 1221; 2112; 2121; 2211; ABC; ACB; BAC; BCA; CAB; CBA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• Maastricht University Medical Center: lead
• University Hospital, Geneva: collaborator
• MED-EL Elektromedizinische Geräte GesmbH: collaborator
• Health Holland: collaborator
• Heinsius-Houbolt Fund: collaborator
• Radboud University Medical Center: collaborator
• Stichting de Weijerhorst: collaborator

Study Sites (1)

Maastricht UMC+

Maastricht, Limburg, 6229 HX, Netherlands

Location

Related Publications (30)

• 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.

  PMID: 17561766 BACKGROUND

• 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.

  PMID: 21991260 BACKGROUND

• 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.

  PMID: 21510138 BACKGROUND

• 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.

  PMID: 22363317 BACKGROUND

• 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.

  PMID: 24808890 BACKGROUND

• 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.

  PMID: 25073124 BACKGROUND

• 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.

  PMID: 24869447 BACKGROUND

• 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.

  PMID: 26366566 BACKGROUND

• 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.

  PMID: 25653601 BACKGROUND

• 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.

  PMID: 26367113 BACKGROUND

• 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.

  PMID: 26737951 BACKGROUND

• 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.

  PMID: 27396631 BACKGROUND

• 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.

  PMID: 27148528 BACKGROUND

• 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.

  PMID: 27083882 BACKGROUND

• 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.

  PMID: 28066163 BACKGROUND

• 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.

  PMID: 29209162 BACKGROUND

• 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.

  PMID: 29184530 BACKGROUND

• 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.

  PMID: 29312107 BACKGROUND

• 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.

  PMID: 28387690 BACKGROUND

• 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.

  PMID: 28443060 BACKGROUND

• 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.

  PMID: 31396689 BACKGROUND

• 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.

  PMID: 30566413 BACKGROUND

• 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.

  PMID: 31661687 BACKGROUND

• 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.

  PMID: 31225823 BACKGROUND

• 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.

  PMID: 31677739 BACKGROUND

• 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.

  PMID: 32213673 BACKGROUND

• 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.

  PMID: 32651339 BACKGROUND

• 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.

  PMID: 40112351 DERIVED

• 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.

  PMID: 39885011 DERIVED

• 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.

  PMID: 38547135 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Bilateral Vestibulopathy

Condition Hierarchy (Ancestors)

Vestibular Diseases; Labyrinth Diseases; Ear Diseases; Otorhinolaryngologic Diseases; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Raymond van de Berg, MD, PhD

  Maastricht UMC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DEVICE FEASIBILITY
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Controlled clinical trial with a randomized single-blind 3-treatment 3-period crossover design during the in-hospital part

Study Record Dates

• First Submitted: April 28, 2021
• First Posted: June 9, 2021
• Study Start: July 1, 2021
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2029
• Last Updated: January 16, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Data will be available 6 months after completion of the prolonged stimulation period
• Access Criteria: A data agreement including research proposal needs to be signed prior to data sharing.

Locations

NL (1)