Guidetti M, Bocci T, De Pedro Del Álamo M, Deuschl G, Fasano A, Fernandez R Martinez, Gasca-Salas C, Hamani C, Krauss J K, Kühn A A, Limousin P, Little S, Lozano A M, Maiorana N V, Marceglia S, Okun M S, Oliveri S, Ostrem J L, Scelzo E, Schnitzler A, Starr P A, Temel Y, Timmermann L, Tinkhauser G, Visser-Vandewalle V, Volkmann J, Priori A
"Aldo Ravelli" Center for Neurotechnology and Experimental Brain Therapeutics, Department of Health Sciences, University of Milan, Via Antonio di Rudinì 8, 20142 Milan, Italy.
Clinical Neurology Unit, "Azienda Socio-Sanitaria Territoriale Santi Paolo e Carlo", Department of Health Sciences, University of Milan, Via Antonio di Rudinì 8, 20142 Milan, Italy.
medRxiv. 2024 Aug 26:2024.08.26.24312580. doi: 10.1101/2024.08.26.24312580.
If history teaches, as cardiac pacing moved from fixed-rate to on-demand delivery in in 80s of the last century, there are high probabilities that closed-loop and adaptive approaches will become, in the next decade, the natural evolution of conventional Deep Brain Stimulation (cDBS). However, while devices for aDBS are already available for clinical use, few data on their clinical application and technological limitations are available so far. In such scenario, gathering the opinion and expertise of leading investigators worldwide would boost and guide practice and research, thus grounding the clinical development of aDBS.
We identified clinical and academically experienced DBS clinicians (n=21) to discuss the challenges related to aDBS. A 5-point Likert scale questionnaire along with a Delphi method was employed. 42 questions were submitted to the panel, half of them being related to technical aspects while the other half to clinical aspects of aDBS. Experts agreed that aDBS will become clinical practice in 10 years. In the present scenario, although the panel agreed that aDBS applications require skilled clinicians and that algorithms need to be further optimized to manage complex PD symptoms, consensus was reached on aDBS safety and its ability to provide a faster and more stable treatment response than cDBS, also for tremor-dominant Parkinson's disease patients and for those with motor fluctuations and dyskinesias.
Despite the need of further research, the panel concluded that aDBS is safe, promises to be maximally effective in PD patients with motor fluctuation and dyskinesias and therefore will enter into the clinical practice in the next years, with further research focused on algorithms and markers for complex symptoms.
如果历史有借鉴意义的话，就像心脏起搏在上世纪80年代从固定频率起搏发展到按需起搏一样，闭环和自适应方法很有可能在未来十年成为传统深部脑刺激（cDBS）的自然发展方向。然而，虽然用于自适应深部脑刺激（aDBS）的设备已可用于临床，但目前关于其临床应用和技术局限性的数据还很少。在这种情况下，收集全球顶尖研究者的意见和专业知识将推动并指导实践与研究，从而为aDBS的临床发展奠定基础。
我们确定了21位临床和学术经验丰富的DBS临床医生，以讨论与aDBS相关的挑战。采用了5级李克特量表问卷和德尔菲法。向专家小组提交了42个问题，其中一半与aDBS的技术方面有关，另一半与临床方面有关。专家们一致认为，aDBS将在10年内成为临床实践。在当前情况下，尽管专家小组一致认为aDBS的应用需要技术熟练的临床医生，并且算法需要进一步优化以管理复杂的帕金森病症状，但对于aDBS的安全性以及它比cDBS能提供更快、更稳定的治疗反应这一点达成了共识，对于以震颤为主的帕金森病患者以及有运动波动和异动症的患者也是如此。
尽管需要进一步研究，但专家小组得出结论，aDBS是安全的，有望在有运动波动和异动症的帕金森病患者中发挥最大疗效，因此将在未来几年进入临床实践，进一步的研究将集中在针对复杂症状的算法和标志物上。
