VertiGO! - Get up and GO! With the Vestibular Implant
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Speech perception with CVI in quiet without simultaneous vestibular stimulation
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Device Feasibility
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
- •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.
排除标准
- •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
研究组 & 干预措施
ABC
In-hospital part
A = Baseline stimulation, no modulation
B = Baseline stimulation, modulation stimulation
C = Reduced baseline stimulation, modulation stimulation
干预措施: Cochlear Vestibular Implant (CVI) (Device)
ACB
In-hospital part
A = Baseline stimulation, no modulation
C = Reduced baseline stimulation, modulation stimulation
B = Baseline stimulation, modulation stimulation
干预措施: Cochlear Vestibular Implant (CVI) (Device)
BAC
In-hospital part
B = Baseline stimulation, modulation stimulation
A = Baseline stimulation, no modulation
C = Reduced baseline stimulation, modulation stimulation
干预措施: Cochlear Vestibular Implant (CVI) (Device)
BCA
In-hospital part
B = Baseline stimulation, modulation stimulation
C = Reduced baseline stimulation, modulation stimulation
A = Baseline stimulation, no modulation
干预措施: Cochlear Vestibular Implant (CVI) (Device)
CAB
In-hospital part
C = Reduced baseline stimulation, modulation stimulation
A = Baseline stimulation, no modulation
B = Baseline stimulation, modulation stimulation
干预措施: Cochlear Vestibular Implant (CVI) (Device)
CBA
In-hospital part
C = Reduced baseline stimulation, modulation stimulation
B = Baseline stimulation, modulation stimulation
A = Baseline stimulation, no modulation
干预措施: Cochlear Vestibular Implant (CVI) (Device)
1122
Home-use part, preference phase
- - individualized vestibular stimulation
- - control vestibular stimulation
干预措施: Cochlear Vestibular Implant (CVI) (Device)
1212
Home-use part, preference phase
- - individualized vestibular stimulation
- - control vestibular stimulation
干预措施: Cochlear Vestibular Implant (CVI) (Device)
1221
Home-use part, preference phase
- - individualized vestibular stimulation
- - control vestibular stimulation
干预措施: Cochlear Vestibular Implant (CVI) (Device)
2211
Home-use part, preference phase
- - individualized vestibular stimulation
- - control vestibular stimulation
干预措施: Cochlear Vestibular Implant (CVI) (Device)
2121
Home-use part, preference phase
- - individualized vestibular stimulation
- - control vestibular stimulation
干预措施: Cochlear Vestibular Implant (CVI) (Device)
2112
Home-use part, preference phase
- - individualized vestibular stimulation
- - control vestibular stimulation
干预措施: Cochlear Vestibular Implant (CVI) (Device)
结局指标
主要结局
Speech perception with CVI in quiet without simultaneous vestibular stimulation
时间窗: 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
时间窗: 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
时间窗: 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 passive head movements
时间窗: 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
时间窗: 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 balance based on clinical evaluation
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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.
The feasibility of vestibular stimulation improving Dynamic Visual Acuity during walking
时间窗: 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 vestibular stimulation will be evaluated through the in-hospital and home-use parts.
The feasibility of vestibular stimulation improving gait stability and balance based on motion capture data on a treadmill
时间窗: 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 gait stability and balance based on motion capture data overground
时间窗: Through each home-use phase, 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 vestibular stimulation will be evaluated through each phase during the home-use part of the trial.
次要结局
- Evaluating the influence of receiving and using a CVI on anxiety and depression(Through the full trial period, until 5 years after implantation)
- Characterization of study population on perceived severity of oscillopsia(Measured pre-operatively and directly before the start of the VI stimulation period)
- Characterization of study population on perceived health-related quality of life(Measured pre-operatively and directly before the start of the VI stimulation period)
- 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 receiving and using a CVI on capabilities in life(Through the full trial period, until 5 years after implantation)
- Characterization of study population on perceived dizziness(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)
- Evaluating the daily experience with vestibular stimulation(Through each 4-day VI stimulation period, within 2 years after implantation)
- Characterization of study population on perceived risk of falling(Measured pre-operatively and directly before the start of the VI stimulation period)
- Characterizing the participant's experience with vestibular stimulation(Through each 4-day VI stimulation period, within 2 years after implantation)