de Freitas Roberto M, Bhatia Shovan, Sorensen Erynn, Verma Nikhil, Carranza Erick, Ensel Scott, Borda Luigi, Boos Amy, Goldsmith Jeff, Fisher Lee E, Fields Daryl P, Powell Marc P, Gordon Shane, Balzer Jeffrey, Friedlander Robert M, Wittenberg George F, Gerszten Peter C, Krakauer John W, Pirondini Elvira, Weber Douglas J, Capogrosso Marco
Department of Neurological Surgery, University of Pittsburgh, Pittsburgh, PA, USA.
Rehab Neural Engineering Labs, University of Pittsburgh, Pittsburgh, PA, USA.
Res Sq. 2025 Aug 18:rs.3.rs-7271578. doi: 10.21203/rs.3.rs-7271578/v1.
Here, we report the final outcomes of a pilot clinical trial testing preliminary efficacy and safety of cervical epidural spinal cord stimulation (SCS) for chronic post-stroke upper-limb hemiparesis (NCT04512690). We implanted seven participants with profound motor deficits (Fugl-Meyer Assessment [FMA] scores 15-35) using two leads implanted unilaterally in the cervical spinal cord for 4 weeks. Under SCS ON, motor function immediately improved regardless of impairment severity (average +32% strength and +5.6 FMA-points). Notably, 3/7 participants with residual corticospinal connectivity to finger muscles regained hand/finger function with SCS. Despite performing only 8.6hrs of motor activity (5.5hrs with SCS ON), participants improved by average +6.6 FMA-points at the end of the study compared to baseline and spasticity decreased in all participants. While all benefited, our preliminary analysis indicates that spared sensory function may be a determinant of responsiveness to SCS. No serious adverse events occurred.
在此,我们报告了一项试点临床试验的最终结果,该试验旨在测试颈段硬膜外脊髓刺激(SCS)治疗慢性中风后上肢偏瘫的初步疗效和安全性(NCT04512690)。我们为7名有严重运动功能障碍的参与者(Fugl-Meyer评估[FMA]评分15 - 35)单侧植入两根电极至颈脊髓,进行为期4周的刺激。在SCS开启状态下,无论损伤严重程度如何,运动功能立即得到改善(力量平均增加32%,FMA评分增加5.6分)。值得注意的是,7名参与者中有3名与手指肌肉仍保留皮质脊髓连接的患者在接受SCS治疗后恢复了手/手指功能。尽管参与者仅进行了8.6小时的运动活动(其中5.5小时为SCS开启状态),但与基线相比,研究结束时参与者的FMA评分平均提高了6.6分,且所有参与者的痉挛程度均有所减轻。虽然所有参与者都从中受益,但我们的初步分析表明,保留的感觉功能可能是对SCS反应性的一个决定因素。未发生严重不良事件。