Remote Versus In-Person Follow-up Programming After Subthalamic Deep Brain Stimulation for Parkinson's Disease: A Multicenter Randomized Noninferiority Trial.

IF 7.6
Juhi Shaik, Weidong Zhang, Verena Zentsch, Carsten Buhmann, Ute Hidding, Thomas M Kinfe, Martin Regensburger, Jost-Julian Rumpf, Alfons Schnitzler, Jing Dong, Maximilian Scherer, Elisabeth Kaufmann, Johannes Levin, Alexander Crispin, Günter Höglinger, Jan H Mehrkens, Thomas Koeglsperger
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Abstract

Background: Remote programming of deep brain stimulation may improve access to specialized postoperative care for people with Parkinson's disease, but prospective randomized evidence remains limited.

Objective: We aimed to determine whether remote follow-up programming after standardized inpatient initiation is noninferior to conventional in-person follow-up programming for motor outcomes during the early postoperative period.

Methods: In this prospective, randomized, open-label, multicenter noninferiority trial, adults with idiopathic Parkinson's disease who recently underwent bilateral subthalamic nucleus deep brain stimulation implantation at six German centers were randomly assigned 1:1 to conventional in-person follow-up programming or remote follow-up programming through a secure telemedicine platform during the first 90 days after surgery. All participants underwent initial in-person postoperative programming before randomization. The primary outcome was the Movement Disorder Society-Unified Parkinson's Disease Rating Scale Part III score at 90 days in the medication on and stimulation ON state. The prespecified noninferiority margin was 5 points.

Results: Fifty-two participants were randomly assigned. The per-protocol population included 26 participants in the conventional care group and 22 in the remote programming group. The between-group median difference of the primary endpoint was -2.5 points (95% confidence interval, -9.0 to 2.0), meeting the prespecified noninferiority criterion. Secondary clinical outcomes and patient-reported outcomes were broadly comparable between groups. Serious adverse events occurred at similar frequencies in both groups, and no deaths occurred.

Conclusions: Remote follow-up programming after standardized inpatient initiation achieved motor outcomes noninferior to conventional in-person follow-up during the first 3 months, with no clear short-term safety signal. © 2026 The Author(s). Movement Disorders published by Wiley Periodicals LLC on behalf of International Parkinson and Movement Disorder Society.

丘脑下深部脑刺激治疗帕金森病后远程随访与现场随访:一项多中心随机非劣效性试验
背景:脑深部电刺激的远程编程可能改善帕金森病患者术后专科护理的可及性,但前瞻性随机证据仍然有限。目的:我们旨在确定标准化住院患者开始后的远程随访规划是否优于传统的现场随访规划,以改善术后早期的运动预后。方法:在这项前瞻性、随机、开放标签、多中心非自卑性试验中,最近在德国6个中心接受双侧丘脑下核深部脑刺激植入的特发性帕金森病成人患者在手术后的前90天内随机按1:1分配到传统的现场随访计划或通过安全的远程医疗平台进行远程随访计划。在随机化之前,所有参与者都进行了最初的面对面术后规划。主要结果是运动障碍学会-统一帕金森病评定量表第三部分在药物和刺激状态下90天的评分。预定的非劣效性差为5分。结果:52名参与者被随机分配。按方案人群包括26名常规护理组和22名远程编程组的参与者。主要终点的组间中位差为-2.5点(95%置信区间为-9.0 ~ 2.0),满足预定的非劣效性标准。次要临床结果和患者报告的结果在两组之间具有广泛的可比性。两组发生严重不良事件的频率相似,未发生死亡。结论:标准化住院患者启动后的远程随访程序在前3个月的运动结果不逊于常规的现场随访,没有明确的短期安全信号。©2026作者。Wiley期刊有限责任公司代表国际帕金森和运动障碍学会出版的《运动障碍》。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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