神经损伤后宫外周刺激的影响:I/II期开放标签受控CE-STAND试验的协议
Nadine Mansour1, Manda Keller-Ross2, Walter Low1
1Department of Neurosurgery, University of Minnesota Medical School, Minneapolis, Minnesota, USA.
BMJ open
|February 13, 2026
概括
这项研究研究了脊髓损伤患者的宫外周刺激 (eSCS),旨在改善运动控制和自主功能. 结果将指导未来的eSCS应用程序,以提高生活质量.
科学领域:
- 神经科学是一个神经科学.
- 生物医学工程 生物医学工程
- 临床试验 临床试验
背景情况:
- 脊髓损伤 (SCI) 每年影响超过18000人,导致显著的运动和自主功能障碍,降低生活质量.
- 外周脊髓刺激 (eSCS) 显示出在慢性SCI中功能恢复的前景.
- 对于宫SCI和相关的自主功能障碍的eSCS存在有限的研究.
研究的目的:
- 评估eSCS在改善宫SCI患者自主和意志功能方面的安全性和有效性.
- 评估eSCS对干部稳定性,肠道,膀和性功能的影响.
- 确定eSCS对SCI患者整体生活质量的影响.
主要方法:
- 一/二期临床试验,参与者作为自己的对照.
- 植入阿博特Eterna外周刺激器系统.
- 贝叶斯优化来确定最佳刺激参数,36名参与者被录取并在4年的研究期间进行1年的跟踪.
主要成果:
- 没有 - 目前正在进行研究.
结论:
- CE-STAND试验旨在扩大慢性宫SCI的eSCS应用,提高患者的治疗成果,并可能降低医疗保健成本.
- 未来的研究可能涉及更大的样本大小,长期安全评估和随机对照试验.
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