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一种用于脊髓损伤后恢复血流动力学稳定性的植入式系统。

An implantable system to restore hemodynamic stability after spinal cord injury.

作者信息

Phillips Aaron A, Gandhi Aasta P, Hankov Nicolas, Hernandez-Charpak Sergio D, Rimok Julien, Incognito Anthony V, Nijland Anouk E J, D'Ercole Marina, Watrin Anne, Berney Maxime, Damianaki Aikaterini, Dumont Grégory, Macellari Nicolò, De Herde Laura, Intering Nadine, Smith Donovan, Miller Ryan, Smith Meagan N, Lee Jordan, Baaklini Edeny, Ledoux Jean-Baptiste, Ordonnez Javier G, Newton Taylor, Meliadò Ettore Flavio, Duguet Léa, Jacquet Charlotte, Bole-Feysot Léa, Rieger Markus, Gelenitis Kristen, Dumeny Yoann, Caban Miroslav, Ganty Damien, Paoles Edoardo, Baumgartner Thomas, Harte Cathal, Sasportes Charles David, Romo Paul, Vouga Tristan, Fasola Jemina, Ravier Jimmy, Gautier Matthieu, Merlos Frédéric, Buschman Rik, Milekovic Tomislav, Rowald Andreas, Mandija Stefano, van den Berg Cornelis A T, Kuster Niels, Neufeld Esra, Pralong Etienne, Hirt Lorenz, Carda Stefano, Becce Fabio, Aleton Etienne, Rogan Kyle, Schoettker Patrick, Wuerzner Grégoire, Langerak Nelleke, Keijsers Noël L W, Kwon Brian K, Guest James D, Ross Erika, Murphy John, Kurt Erkan, Casha Steve, Girgis Fady, van Nes Ilse, Larkin-Kaiser Kelly A, Demesmaeker Robin, Asboth Léonie, Squair Jordan W, Bloch Jocelyne, Courtine Grégoire

机构信息

Department of Physiology and Pharmacology, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada.

Department of Clinical Neurosciences, Hotchkiss Brain Institute, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada.

出版信息

Nat Med. 2025 Sep;31(9):2946-2957. doi: 10.1038/s41591-025-03614-w. Epub 2025 Sep 17.

Abstract

A spinal cord injury (SCI) causes immediate and sustained hemodynamic instability that threatens neurological recovery and impacts quality of life. Here we establish the clinical burden of chronic hypotensive complications due to SCI in 1,479 participants and expose the ineffective treatment of these complications with conservative measures. To address this clinical burden, we developed a purpose-built implantable system based on biomimetic epidural electrical stimulation (EES) of the spinal cord that immediately triggered robust pressor responses. The system durably reduced the severity of hypotensive complications in people with SCI, removed the necessity for conservative treatments, improved quality of life and enabled superior engagement in activities of daily living. Central to the development of this therapy was the head-to-head demonstration in the same participants that EES must target the last three thoracic segments, and not the lumbosacral segments, to achieve the safe and effective regulation of blood pressure in people with SCI. These findings in 14 participants establish the path to designing a pivotal device trial that will evaluate the safety and efficacy of EES to treat the underappreciated, treatment-resistant hypotensive complications due to SCI.

摘要

脊髓损伤(SCI)会导致即刻且持续的血流动力学不稳定,这会威胁神经功能恢复并影响生活质量。在此,我们确定了1479名参与者中因SCI导致的慢性低血压并发症的临床负担,并揭示了采用保守措施对这些并发症的治疗效果不佳。为解决这一临床负担,我们基于脊髓仿生硬膜外电刺激(EES)开发了一种专门设计的可植入系统,该系统能立即引发强烈的升压反应。该系统持续降低了SCI患者低血压并发症的严重程度,消除了保守治疗的必要性,改善了生活质量,并使患者在日常生活活动中能有更好的参与度。这种疗法开发的关键在于在同一批参与者中进行的直接对比,即EES必须针对最后三个胸段而非腰骶段,才能实现对SCI患者血压的安全有效调节。14名参与者的这些发现为设计一项关键器械试验奠定了基础,该试验将评估EES治疗因SCI导致的未得到充分认识、治疗抵抗的低血压并发症的安全性和有效性。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/48d8/12443590/60759b50531e/41591_2025_3614_Fig1_HTML.jpg

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