Feasibility of Real-Time Conditional Sacral Neuromodulation Using Wireless Bladder Pressure Sensor.
Feasibility of Real-Time Conditional Sacral Neuromodulation Using Wireless Bladder Pressure Sensor.
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DOI：
10.1109/tnsre.2021.3117518
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发表时间：
2021
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连续骶神经调节（SNM）用于治疗膀胱过度活动症，减少漏尿并增加容量。有条件 SNM 通过刺激来响应不断变化的膀胱状况，并且是研究各种疾病状态下神经调节效应的机会。这种方法的一个关键优点是节省刺激脉冲消耗的功率。这项研究证明了使用无线膀胱压力传感器、实时控制算法和美敦力 Summit™ RC+S 神经刺激研究系统自动应用神经调节的可行性。这项研究在 4 只雌性绵羊身上测试了五天内四种条件 SNM 范式的可行性。主要成果评估了闭环系统功能的概念证明。虽然膀胱压力传感器与同步导管压力测量的相关性很弱（相关性为 0.26-0.89，中值 r=0.52），但传感器和算法足够准确，可以适当地自动触发 SNM。神经刺激器执行了 98.5% 的传输刺激命令，中位延迟为 72 毫秒 (n=1,206)，表明该平台可以实现快速决策和控制。平均而言，连续 SNM 和算法控制范例的膀胱容量有所增加。一些动物对有条件的 SNM 反应更强烈，这表明治疗可以个体化。条件 SNM 的未来研究可能会阐明差异反应的生理基础并实现临床转化。
Continuous sacral neuromodulation (SNM) is used to treat overactive bladder, reducing urine leakage and increasing capacity. Conditional SNM applies stimulation in response to changing bladder conditions, and is an opportunity to study neuromodulation effects in various disease states. A key advantage of this approach is saving power consumed by stimulation pulses. This study demonstrated feasibility of automatically applying neuromodulation using a wireless bladder pressure sensor, a real-time control algorithm, and the Medtronic Summit™ RC+S neurostimulation research system. This study tested feasibility of four conditional SNM paradigms over five days in 4 female sheep. Primary outcomes assessed proof of concept of closed-loop system function. While the bladder pressure sensor correlated only weakly to simultaneous catheter-based pressure measurement (correlation 0.26-0.89, median r=0.52), the sensor and algorithm were accurate enough to automatically trigger SNM appropriately. The neurostimulator executed 98.5% of transmitted stimulation commands with a median latency of 72 ms (n=1,206), suggesting that rapid decision-making and control is feasible with this platform. On average, bladder capacity increased for continuous SNM and algorithm-controlled paradigms. Some animals responded more strongly to conditional SNM, suggesting that treatment could be individualized. Future research in conditional SNM may elucidate the physiologic underpinnings of differential response and enable clinical translation.