VertiGO! - Get up and GO! With the Vestibular Implant
- Conditions
- Bilateral Vestibular Loss
- Interventions
- Device: Cochlear Vestibular Implant (CVI)
- Registration Number
- NCT04918745
- Lead Sponsor
- Maastricht University Medical Center
- 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 make use of this combined stimulation during 3 weeks of prolonged use under supervision in a hospital environment. This trial will serve as a proof-of-concept for restoring vestibular function in patients with BV, an as-of-yet untreatable disorder causing severe impairment and discomfort. The aims of this trial are to investigate efficacy and safety of prolonged vestibular stimulation, to identify the influence of different stimulation algorithms, to assess the feasibility of the combined VI/CI device, to develop a VI rehabilitation program and to further build on the fundamental knowledge of vestibular organ stimulation while also taking into account the patient perspective.
- Detailed Description
The vestibular sensory organ is essential for balance and image stabilization. Patients with severe function loss of both vestibular organs present themselves with serious day-to-day disabilities such as strong balance disturbances, higher risk of falling, visual symptoms (oscillopsia) and a loss of autonomy. Up until now no effective treatment is available for these patients to restore vestibular function. In the past years experimental electric stimulation of the vestibular nerve in humans by means of a VI has shown to be able to partly restore balance and gaze functionality in test situations.
To evaluate combined prolonged stimulation of both the vestibular organ and the cochlea, participants will be implanted with a CVI. This modified CI also consists of 3 vestibular electrodes, each placed in individual electrode leads for insertion into the three semicircular canals. Therefore the CVI is capable of stimulating both the cochlear and vestibular nerves. Hearing rehabilitation with the CI part of the device will follow the standard clinical protocol, with the participant using a standard CI processor. Functionality of prolonged combined vestibular and cochlear stimulation will be assessed using a research processor during 3 weeks (3x4 days, +- 8 hours a day) of prolonged stimulation under supervision in the safety of a hospital environment.
During each identical period of 4 days a different stimulation algorithm will be used for vestibular stimulation, with the order being randomized and single-blinded. The stimulation algorithms which will be used are (1) baseline stimulation without motion modulation, (2) baseline stimulation with motion modulation, and (3) reduced baseline stimulation with motion modulation. Alongside the 3 weeks of prolonged stimulation, the participant will make yearly visits to our clinic up to 5 years after implantation for evaluation of long-term response to acute vestibular stimulation and general CI performance.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 13
Not provided
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description ACB Cochlear Vestibular Implant (CVI) A = Baseline stimulation, no modulation C = Reduced baseline stimulation, modulation stimulation B = Baseline stimulation, modulation stimulation CAB Cochlear Vestibular Implant (CVI) C = Reduced baseline stimulation, modulation stimulation A = Baseline stimulation, no modulation B = Baseline stimulation, modulation stimulation CBA Cochlear Vestibular Implant (CVI) C = Reduced baseline stimulation, modulation stimulation B = Baseline stimulation, modulation stimulation A = Baseline stimulation, no modulation BCA Cochlear Vestibular Implant (CVI) B = Baseline stimulation, modulation stimulation C = Reduced baseline stimulation, modulation stimulation A = Baseline stimulation, no modulation BAC Cochlear Vestibular Implant (CVI) B = Baseline stimulation, modulation stimulation A = Baseline stimulation, no modulation C = Reduced baseline stimulation, modulation stimulation ABC Cochlear Vestibular Implant (CVI) A = Baseline stimulation, no modulation B = Baseline stimulation, modulation stimulation C = Reduced baseline stimulation, modulation stimulation
- Primary Outcome Measures
Name Time Method Speech perception with CVI in quiet without simultaneous vestibular stimulation 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
Speech perception with CVI in noise without simultaneous vestibular stimulation 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
Safety of vestibular stimulation via the CVI Through full trial period, 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 Through each 4-day VI stimulation period, within 2 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 with each stimulation algorithm being evaluated separately.
The feasibility of vestibular stimulation improving Dynamic Visual Acuity during passive head movements Through each 4-day VI stimulation period, within 2 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 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.
The feasibility of vestibular stimulation improving the self-movement perception in dark Through each 4-day VI stimulation period, within 2 years after implantation 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.
The feasibility of vestibular stimulation improving gait stability and balance based on motion capture data Through each 4-day VI stimulation period, within 2 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 through each 4-day stimulation period with each stimulation algorithm being evaluated separately.
The feasibility of vestibular stimulation improving balance based on clinical evaluation Through each 4-day VI stimulation period, within 2 years after implantation 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.
Interaction between vestibular and cochlear stimulation on speech perception in quiet Through each 4-day VI stimulation period, within 2 years after implantation 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.
Change in otolith function due to CVI implantation 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.
The feasibility of vestibular stimulation restoring the high-frequency vestibulo-ocular reflex Through each 4-day VI stimulation period, within 2 years after implantation 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.
The feasibility of vestibular stimulation restoring the low-frequency vestibulo-ocular reflex Through each 4-day VI stimulation period, within 2 years after implantation 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.
Vestibular and cochlear electrode location 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.
- Secondary Outcome Measures
Name Time Method Evaluating the influence of receiving and using a CVI on anxiety and depression Through the full trial period, until 5 years after implantation 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.
Characterization of study population on perceived severity of oscillopsia Measured pre-operatively and directly before the start of the VI stimulation period Characterizing the study population based on their perceived severity of oscillopsia measured with the Oscillopsia Severity Questionnaire
Characterization of study population on perceived health-related quality of life Measured pre-operatively and directly before the start of the VI stimulation period Characterizing the study population based on their perceived health-related quality of life measured with the Health Utility Index - 3
Evaluating the influence of receiving and using a CVI on quality of life Through the full trial period, until 5 years after implantation 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
Evaluating the influence of receiving and using a CVI on capabilities in life Through the full trial period, until 5 years after implantation 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.
Characterization of study population on perceived dizziness Measured pre-operatively and directly before the start of the VI stimulation period Characterizing the study population based on their perceived dizziness and the related handicap measured with the Dizziness Handicap Inventory.
Subjective hearing performance of the CVI Yearly evaluation through the full trial period, until 5 years after implantation Evaluating the subjective hearing performance of the CVI measured with the Speech and Spatial Qualities of hearing scale-12
Effect of CVI implantation on tinnitus burden Pre-operatively and 1 month postoperatively Evaluating the influence of CVI implantation on the subjective severity and burden of tinnitus measured with the Tinnitus Questionnaire
Evaluating the daily experience with vestibular stimulation Through each 4-day VI stimulation period, within 2 years after implantation 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.
Characterization of study population on perceived risk of falling Measured pre-operatively and directly before the start of the VI stimulation period Characterizing the study population based on their perceived risk of falling measured with the Falls Efficacy Scale-International
Characterizing the participant's experience with vestibular stimulation Through each 4-day VI stimulation period, within 2 years after implantation Semi-standardized interviews for in-depth qualitative analysis of the participant's experience with receiving vestibular stimulation (via the CVI)
Trial Locations
- Locations (1)
Maastricht UMC+
š³š±Maastricht, Limburg, Netherlands