Gharabaghi Alireza, Groppa Sergiu, Navas-Garcia Marta, Schnitzler Alfons, Muñoz-Delgado Laura, Marshall Vicky L, Karl Jessica, Zhang Lin, Alvarez Ramiro, Feldman Mary S, Soileau Michael J, Luo Lan, Zauber S Elizabeth, Walter Benjamin L, Wu Chengyuan, Lei Hong, Herz Damian M, Chung Ming-Hua, Pathak Yagna, Blomme Bram, Cheeran Binith, Luca Corneliu, Weiss Daniel
Institute for Neuromodulation and Neurotechnology, University Hospital Tübingen (UKT), Faculty of Medicine, University Tübingen, 72076, Tübingen, Germany.
Center for Bionic Intelligence Tübingen Stuttgart (BITS), 72076, Tübingen, Germany.
Commun Med (Lond). 2025 Jan 31;5(1):31. doi: 10.1038/s43856-025-00744-7.
Deep brain stimulation (DBS) has emerged as an important therapeutic intervention for neurological and neuropsychiatric disorders. After initial programming, clinicians are tasked with fine-tuning DBS parameters through repeated in-person clinic visits. We aimed to evaluate whether DBS patients achieve clinical benefit more rapidly by incorporating remote internet-based adjustment (RIBA) of stimulation parameters into the continuum of care.
We conducted a randomized controlled multicenter study (ClinicalTrails.gov NCT05269862) involving patients scheduled for de novo implantation with a DBS System to treat Parkinson's Disease. Eligibility criteria included the ability to incorporate RIBA as part of routine follow-up care. Ninety-six patients were randomly assigned in a 1:1 ratio using automated allocation, blocked into groups of 4, allocation concealed, and no stratification. After surgery and initial configuration of stimulation parameters, optimization of DBS settings occurred in the clinic alone (IC) or with additional access to RIBA. The primary outcome assessed differences in the average time to achieve a one-point improvement on the Patient Global Impression of Change score between groups. Patients, caregivers, and outcome assessors were not blinded to group assignment. Most of the data collection took place in the patient's home environment.
Access to RIBA reduces the time to symptom improvement, with patients reporting 15.1 days faster clinical benefit (after 39.1 (SD 3.3) days in the RIBA group (n = 48) and after 54.2 (SD 3.7) days in the IC group (n = 48)). None of the reported adverse events are related to RIBA.
This study demonstrates safety and efficacy of internet-based adjustment of DBS therapy, while providing clinical benefit earlier than in-clinic optimization of stimulation parameters by increasing patient access to therapy adjustment.
深部脑刺激（DBS）已成为治疗神经和神经精神疾病的重要治疗手段。在初始编程后，临床医生的任务是通过反复的门诊亲自就诊来微调DBS参数。我们旨在评估将基于互联网的刺激参数远程调整（RIBA）纳入连续护理中，DBS患者是否能更快地获得临床益处。
我们进行了一项随机对照多中心研究（ClinicalTrails.gov NCT05269862），研究对象为计划初次植入DBS系统以治疗帕金森病的患者。纳入标准包括能够将RIBA作为常规随访护理的一部分。96名患者使用自动分配以1:1的比例随机分组，每4人一组进行分组，分配过程保密，且不进行分层。在手术和刺激参数的初始配置后，DBS设置的优化仅在诊所（IC）进行，或额外通过RIBA进行。主要结局评估两组之间在患者整体变化印象评分上达到1分改善的平均时间差异。患者、护理人员和结局评估者均未对分组情况进行盲法处理。大多数数据收集在患者家中环境进行。
使用RIBA可缩短症状改善时间，患者报告临床获益快15.1天（RIBA组（n = 48）在39.1（标准差3.3）天后，IC组（n = 48）在54.2（标准差3.7）天后）。报告的不良事件均与RIBA无关。
本研究证明了基于互联网的DBS治疗调整的安全性和有效性，通过增加患者获得治疗调整的机会，比在诊所优化刺激参数更早地提供临床益处。
