The vestibular implant: Opinion statement on implantation criteria for research.
The vestibular implant: Opinion statement on implantation criteria for research.
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DOI：
10.3233/ves-200701
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发表时间：
2020
期刊：
影响因子：
--
通讯作者：
Guinand N
中科院分区：
文献类型：
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作者：
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
本意见声明提出了一套在研究环境中双侧前庭病变（BVP）成人患者前庭植入的候选标准。标准包括致残性慢性症状，如姿势不平衡、步态不稳和/或头部运动引起的眩晕，以及双耳前庭功能降低或缺失的客观体征。这些体征包括头部脉冲（视频头部脉冲试验或巩膜线圈技术）、双温冷热试验和旋转椅试验（0.1 Hz正弦刺激）期间记录的异常试验结果。 前庭植入物（VI）植入标准与双侧前庭病变的诊断标准不同。VI植入标准与批准的BVP诊断标准之间的主要差异在于，所有纳入的半规管功能前庭试验（头部冲动试验、冷热试验和转椅试验）均需显示植入标准中的前庭功能显著受损。为此，开发了两步范式。首先，至少有一项前庭测试需要满足严格的标准，接近BVP的标准。如果这是适用的，那么其他前庭测试必须满足第二组标准，其比BVP的原始标准不那么严格。如果VI植入旨在刺激椭圆囊和/或球囊（耳石刺激），除了上述半规管功能异常外，必须不存在对颈部和眼部前庭诱发肌源性电位的反应。最后，应满足安全且潜在有效刺激的要求，包括仅向患者植入外周来源的BVP，并评估可能的医疗和精神禁忌症。
This opinion statement proposes a set of candidacy criteria for vestibular implantation of adult patients with bilateral vestibulopathy (BVP) in a research setting. The criteria include disabling chronic symptoms like postural imbalance, unsteadiness of gait and/or head movement-induced oscillopsia, combined with objective signs of reduced or absent vestibular function in both ears. These signs include abnormal test results recorded during head impulses (video head impulse test or scleral coil technique), bithermal caloric testing and rotatory chair testing (sinusoidal stimulation of 0.1 Hz). Vestibular implant (VI) implantation criteria are not the same as diagnostic criteria for bilateral vestibulopathy. The major difference between VI-implantation criteria and the approved diagnostic criteria for BVP are that all included vestibular tests of semicircular canal function (head impulse test, caloric test, and rotatory chair test) need to show significant impairments of vestibular function in the implantation criteria. For this, a two-step paradigm was developed. First, at least one of the vestibular tests needs to fulfill stringent criteria, close to those for BVP. If this is applicable, then the other vestibular tests have to fulfill a second set of criteria which are less stringent than the original criteria for BVP. If the VI-implantation is intended to excite the utricle and/or saccule (otolith stimulation), responses to cervical and ocular vestibular evoked myogenic potentials must be absent in addition to the above mentioned abnormalities of semicircular canal function. Finally, requirements for safe and potentially effective stimulation should be met, including implanting patients with BVP of peripheral origin only, and assessing possible medical and psychiatric contraindications.