Department of Neurology and Neurological Sciences, School of Medicine, Stanford University, Stanford, CA, USA.
Department of Neurology and Neurological Sciences, School of Medicine, Stanford University, Stanford, CA, USA; Department of Neurosurgery, School of Medicine, Stanford University, Stanford, CA, USA.
Brain Stimul. 2019 Jul-Aug;12(4):868-876. doi: 10.1016/j.brs.2019.02.020. Epub 2019 Feb 25.
Closed loop deep brain stimulation (clDBS) in Parkinson's disease (PD) using subthalamic (STN) neural feedback has been shown to be efficacious only in the acute post-operative setting, using externalized leads and stimulators.
To determine feasibility of neural (N)clDBS using the clinical implanted neurostimulator (Activa™ PC + S, FDA IDE approved) and a novel beta dual threshold algorithm in tremor and bradykinesia dominant PD patients on chronic DBS.
13 PD subjects (20 STNs), on open loop (ol)DBS for 22 ± 7.8 months, consented to NclDBS driven by beta (13-30 Hz) power using a dual threshold algorithm, based on patient specific therapeutic voltage windows. Tremor was assessed continuously, and bradykinesia was evaluated after 20 min of NclDBS using a repetitive wrist flexion-extension task (rWFE). Total electrical energy delivered (TEED) on NclDBS was compared to olDBS using the same active electrode.
NclDBS was tolerated for 21.67 [21.10-26.15] minutes; no subject stopped early. Resting beta band power was measurable and similar between tremor and bradykinesia dominant patients. NclDBS improved bradykinesia and tremor while delivering only 56.86% of the TEED of olDBS; rWFE velocity (p = 0.003) and frequency (p < 0.001) increased; tremor was below 0.15 rad/sec for 95.4% of the trial and averaged 0.26 rad/sec when present.
This is the first study to demonstrate that STN NclDBS is feasible, efficacious and more efficient than olDBS in tremor and bradykinesia dominant PD patients, on long-term DBS, using an implanted clinical neurostimulator and driven by beta power with a novel dual threshold algorithm, based on customized therapeutic voltage windows.
使用外部化导联和刺激器,在亚丘脑(STN)神经反馈的闭环深部脑刺激(clDBS)在帕金森病(PD)中的应用仅在急性术后环境中显示出有效。
使用临床植入神经刺激器(Activa™ PC+S,FDA IDE 批准)和新型β双阈值算法,确定在慢性 DBS 中震颤和运动迟缓为主的 PD 患者中进行神经(N)clDBS 的可行性。
13 名 PD 患者(20 个 STN),使用开环(ol)DBS 治疗 22±7.8 个月,同意使用基于患者特定治疗电压窗的β(13-30 Hz)功率双阈值算法进行 NclDBS。连续评估震颤,使用重复腕部屈伸任务(rWFE)在 NclDBS 后 20 分钟评估运动迟缓。使用相同的有源电极比较 NclDBS 和 olDBS 的总电能输送(TEED)。
NclDBS 耐受时间为 21.67 [21.10-26.15] 分钟;没有患者提前停止。震颤和运动迟缓为主的患者之间可测量到静息β频带功率且相似。NclDBS 在仅输送 olDBS 的 TEED 的 56.86%时改善了运动迟缓并减轻了震颤;rWFE 速度(p=0.003)和频率(p<0.001)增加;震颤在试验的 95.4%时间内低于 0.15 弧度/秒,当存在时平均为 0.26 弧度/秒。
这是第一项研究,证明在长期 DBS 中,使用植入式临床神经刺激器,基于定制治疗电压窗,通过新型β双阈值算法驱动,在震颤和运动迟缓为主的 PD 患者中,STN NclDBS 是可行、有效且比 olDBS 更有效的。