Sauter-Starace F, Ratel D, Cretallaz C, Foerster M, Lambert A, Gaude C, Costecalde T, Bonnet S, Charvet G, Aksenova T, Mestais C, Benabid Alim-Louis, Torres-Martinez N
Univ. Grenoble Alpes, CEA, Leti, CLINATEC, Grenoble, France.
Univ. Grenoble Alpes, CEA, Leti, DTBS, Grenoble, France.
Front Neurosci. 2019 Aug 21;13:847. doi: 10.3389/fnins.2019.00847. eCollection 2019.
This article deals with the long-term preclinical validation of WIMAGINE (Wireless Implantable Multi-channel Acquisition system for Generic Interface with Neurons), a 64-channel wireless implantable recorder that measures the electrical activity at the cortical surface (electrocorticography, ECoG). The WIMAGINE implant was designed for chronic wireless neuronal signal acquisition, to be used e.g., as an intracranial Brain-Computer Interface (BCI) for severely motor-impaired patients. Due to the size and shape of WIMAGINE, sheep appeared to be the best animal model on which to carry out long-term validation. The devices were implanted in two sheep for a follow-up period of 10 months, including idle state cortical recordings and Somato-Sensory Evoked Potential (SSEP) sessions. ECoG and SSEP demonstrated relatively stable behavior during the 10-month observation period. Information recorded from the SensoriMotor Cortex (SMC) showed an SSEP phase reversal, indicating the cortical site of the sensorimotor activity was retained after 10 months of contact. Based on weekly recordings of raw ECoG signals, the effective bandwidth was in the range of 230 Hz for both animals and remarkably stable over time, meaning preservation of the high frequency bands valuable for decoding of the brain activity using BCIs. The power spectral density (in dB/Hz), on a log scale, was of the order of 2.2, -4.5 and -18 for the frequency bands (10-40), (40-100), and (100-200) Hz, respectively. The outcome of this preclinical work is the first long-term validation of the WIMAGINE implant, highlighting its ability to record the brain electrical activity through the dura mater and to send wireless digitized data to the external base station. Apart from local adhesion of the dura to the skull, the neurosurgeon did not face any difficulty in the implantation of the WIMAGINE device and post-mortem analysis of the brain revealed no side effect related to the implantation. We also report on the reliability of the system; including the implantable device, the antennas module and the external base station.
本文探讨了WIMAGINE(用于与神经元通用接口的无线植入式多通道采集系统)的长期临床前验证情况。WIMAGINE是一款64通道的无线植入式记录仪,用于测量皮质表面的电活动(脑皮层电图,ECoG)。WIMAGINE植入设备专为长期无线神经元信号采集而设计,例如可作为严重运动功能受损患者的颅内脑机接口(BCI)。鉴于WIMAGINE的尺寸和形状,绵羊似乎是进行长期验证的最佳动物模型。将这些设备植入两只绵羊体内,进行为期10个月的随访,包括静息状态下的皮质记录和体感诱发电位(SSEP)实验。在10个月的观察期内,ECoG和SSEP表现出相对稳定的特性。从感觉运动皮层(SMC)记录的信息显示SSEP相位反转,表明在接触10个月后,感觉运动活动的皮质部位得以保留。基于每周对原始ECoG信号的记录,两只动物的有效带宽均在230赫兹范围内,且随时间推移非常稳定,这意味着对使用BCI解码大脑活动有价值的高频频段得以保留。在对数尺度上,频段(10 - 40)赫兹、(40 - 100)赫兹和(100 - 200)赫兹的功率谱密度(单位为dB/Hz)分别约为2.2、 - 4.5和 - 18。这项临床前工作的成果是对WIMAGINE植入设备的首次长期验证,突出了其透过硬脑膜记录脑电活动并将无线数字化数据发送至外部基站的能力。除了硬脑膜与颅骨局部粘连外,神经外科医生在植入WIMAGINE设备时未遇到任何困难,对大脑的尸检分析也未发现与植入相关的副作用。我们还报告了该系统的可靠性,包括可植入设备、天线模块和外部基站。