Long-term stability of the chronic epidural wireless recorder WIMAGINE in tetraplegic patients
Long-term stability of the chronic epidural wireless recorder WIMAGINE in tetraplegic patients
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DOI：
10.1088/1741-2552/ac2003
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发表时间：
2021-10-01
影响因子：
4
通讯作者：
Sauter-Starace, Fabien
中科院分区：
文献类型：
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作者：
Larzabal, Christelle;Bonnet, Stephane;Sauter-Starace, Fabien
目标。皮层脑电(ECoG)信号的长期稳定性评估是一个重要的科学问题，因为新的植入式记录设备可以用于医疗目的，如脑机接口(BCI)或脑监测。接近。对通道硬膜外皮层脑电记录仪WIMAGINE的长期临床验证进行了研究。WIMAGINE装置在BCI方案的背景下被植入两名四肢瘫痪患者。本研究重点研究了2017年6月(P1)和2019年11月(P2)两例双侧植入术患者的ECoG信号稳定性。方法：研究方法。在每次BCI治疗前记录ECoG信号，结果P1和P2分别获得32个月和14个月的随访。采用均方根(RMS)、频带功率(BP)、信噪比(SNR)、有效带宽(EBW)和频谱边缘频率(SEF)等信号评价指标评价植入过程中信号的稳定性。从任务相关的运动激活获得的时间-频率图也被研究，以调查电极的长期选择性。主要结果。基于时间线性回归，我们报告了信号平均电平(RMS)、谱分布(BP)和信噪比(SNR)的有限下降，EBW和SEF具有显著的稳定性。在运动成像过程中获得的时间-频率图显示，术后1个月和2年后的分辨率都很高。结论。随着时间的推移，WIMAGINE硬膜外装置表现出很高的稳定性。两名四肢瘫痪患者分别在32个月和14个月期间的信号评估指标提供了强有力的证据，表明该无线植入物非常适合长期ECoG记录。意义重大。这些发现与植入式脑梗死的未来相关，并可能使其他患有脊髓损伤、肌萎缩侧索硬化症、神经肌肉疾病或耐药癫痫的患者受益。
Objective. The evaluation of the long-term stability of ElectroCorticoGram (ECoG) signals is an important scientific question as new implantable recording devices can be used for medical purposes such as Brain-Computer Interface (BCI) or brain monitoring. Approach. The long-term clinical validation of wireless implantable multi-channel acquisition system for generic interface with neurons (WIMAGINE), a wireless 64-channel epidural ECoG recorder was investigated. The WIMAGINE device was implanted in two quadriplegic patients within the context of a BCI protocol. This study focused on the ECoG signal stability in two patients bilaterally implanted in June 2017 (P1) and in November 2019 (P2). Methods. The ECoG signal was recorded at rest prior to each BCI session resulting in a 32 month and in a 14 month follow-up for P1 and P2 respectively. State-of-the-art signal evaluation metrics such as root mean square (RMS), the band power (BP), the signal to noise ratio (SNR), the effective bandwidth (EBW) and the spectral edge frequency (SEF) were used to evaluate stability of signal over the implantation time course. The time-frequency maps obtained from task-related motor activations were also studied to investigate the long-term selectivity of the electrodes. Main results. Based on temporal linear regressions, we report a limited decrease of the signal average level (RMS), spectral distribution (BP) and SNR, and a remarkable steadiness of the EBW and SEF. Time-frequency maps obtained during motor imagery, showed a high level of discrimination 1 month after surgery and also after 2 years. Conclusions. The WIMAGINE epidural device showed high stability over time. The signal evaluation metrics of two quadriplegic patients during 32 months and 14 months respectively provide strong evidence that this wireless implant is well-suited for long-term ECoG recording. Significance. These findings are relevant for the future of implantable BCIs, and could benefit other patients with spinal cord injury, amyotrophic lateral sclerosis, neuromuscular diseases or drug-resistant epilepsy.