Dohle Esmee, Swanson Eleanor, Jovanovic Luka, Yusuf Suraya, Thompson Lucy, Horsfall Hugo Layard, Muirhead William, Bashford Luke, Brannigan Jamie
Oxford University Hospitals, John Radcliffe Hospital, Oxford, OX3 9DU, UK.
Utrecht University Medical Centre, Utrecht, 3584 CX, Netherlands.
Adv Sci (Weinh). 2025 Aug;12(32):e01912. doi: 10.1002/advs.202501912. Epub 2025 Jul 23.
Implantable brain-computer interfaces (iBCIs) decode neural signals to control external effectors, offering potential to restore function in individuals with severe motor impairments, such as loss of limb function or speech. This systematic review examines the evolution of iBCI research and key bottlenecks to clinical translation, particularly the absence of standardized, clinically meaningful outcome measures. A comprehensive search of MEDLINE, Embase, and CINAHL identifies 112 studies, nearly half (49.1%) published since 2020. Eighty unique iBCI participants were identified, providing the most up-to-date estimate of global users. Research remains concentrated in the United States (83%), with growing contributions from Europe, China, and Australia. Electrocorticography (ECoG)-based devices increasingly emerge alongside micro-electrode arrays. iBCI devices are now being used to control a broader range of effectors, including robotic prosthetics and digital technologies. Although most (69.6%) studies reported outcome measures prospectively, these primarily related to decoding (69.6%) and task performance (62.5%), with only 17.9% assessing clinical outcomes. When cassessed, clinical outcomes were highly heterogeneous due to varied approaches across target populations. iBCIs show potential to restore functional independence at scale. However, challenges remain around cross-subject generalization, scalable implantation, and outcome standardization. Novel measures should be developed collaboratively with engineers, clinicians, and individuals with lived experience of motor impairment.
可植入式脑机接口（iBCIs）通过解码神经信号来控制外部效应器，为恢复严重运动障碍患者（如肢体功能丧失或言语丧失）的功能提供了可能。本系统综述考察了iBCI研究的发展历程以及临床转化的关键瓶颈，尤其是缺乏标准化的、具有临床意义的结局指标。对MEDLINE、Embase和CINAHL进行全面检索后，共识别出112项研究，其中近一半（49.1%）是2020年以来发表的。确定了80名独特的iBCI参与者，提供了全球用户的最新估计数据。研究仍集中在美国（83%），欧洲、中国和澳大利亚的贡献也在不断增加。基于皮层脑电图（ECoG）的设备与微电极阵列一起越来越多地出现。iBCI设备现在正被用于控制更广泛的效应器，包括机器人假肢和数字技术。尽管大多数（69.6%）研究前瞻性地报告了结局指标，但这些主要与解码（69.6%）和任务表现（62.5%）相关，只有17.9%评估了临床结局。评估时，由于不同目标人群的方法不同，临床结局高度异质性。iBCIs显示出大规模恢复功能独立性的潜力。然而，在跨个体推广、可扩展植入和结局标准化方面仍存在挑战。应与工程师、临床医生以及有运动障碍生活经历的个体合作开发新的指标。
