From the Departments of Neurology (M.L.H., M.T., L.E.H., A.L.M., A.D.C., T.L.D., F.T.P., P.H., D.C.) and Neurosurgery (P.E.K.), Vanderbilt University Medical Center, Nashville, TN; Department of Neurology (M.R.D.), Emory University School of Medicine, Atlanta, GA; Laboratory of Molecular Immunology (L.E.H.), National Institute of Allergy and Infectious Diseases, Bethesda, MD; Movement Disorders and Neuromodulation Center (J.L.O.), Department of Neurology, University of California San Francisco; Department of Neurology (K.R.C.), Walter Reed National Military Center, Bethesda; and Department of Epidemiology (L.T.D., A.L.S., D.M.S., J.T.), Johns Hopkins University, Baltimore, MD.
Neurology. 2018 Jul 31;91(5):e463-e471. doi: 10.1212/WNL.0000000000005903. Epub 2018 Jun 29.
To evaluate whether the progression of individual motor features was influenced by early deep brain stimulation (DBS), a post hoc analysis of Unified Parkinson's Disease Rating Scale-III (UPDRS-III) score (after a 7-day washout) was conducted from the 2-year DBS in early Parkinson disease (PD) pilot trial dataset.
The prospective pilot trial enrolled patients with PD aged 50-75 years, treated with PD medications for 6 months-4 years, and no history of dyskinesia or other motor fluctuations, who were randomized to receive optimal drug therapy (ODT) or DBS plus ODT (DBS + ODT). At baseline and 6, 12, 18, and 24 months, all patients stopped all PD therapy for 1 week (medication and stimulation, if applicable). UPDRS-III "off" item scores were compared between the ODT and DBS + ODT groups (n = 28); items with significant between-group differences were analyzed further.
UPDRS-III "off" rest tremor score change from baseline to 24 months was worse in patients receiving ODT vs DBS + ODT ( = 0.002). Rest tremor slopes from baseline to 24 months favored DBS + ODT both "off" and "on" therapy ( < 0.001, = 0.003, respectively). More ODT patients developed new rest tremor in previously unaffected limbs than those receiving DBS + ODT ( = 0.001).
These results suggest the possibility that DBS in early PD may slow rest tremor progression. Future investigation in a larger cohort is needed, and these findings will be tested in the Food and Drug Administration-approved, phase III, pivotal, multicenter clinical trial evaluating DBS in early PD.
This study provides Class II evidence that for patients with early PD, DBS may slow the progression of rest tremor.
评估个体运动特征的进展是否受到早期深部脑刺激（DBS）的影响，对早期帕金森病（PD）试验中 2 年 DBS 的统一帕金森病评定量表-III（UPDRS-III）评分（7 天洗脱期后）进行了事后分析。
这项前瞻性试验招募了年龄在 50-75 岁之间的 PD 患者，这些患者接受 PD 药物治疗的时间为 6 个月至 4 年，且无运动障碍或其他运动波动的病史，他们被随机分配接受最佳药物治疗（ODT）或 DBS+ODT（DBS+ODT）。在基线和 6、12、18 和 24 个月时，所有患者停止所有 PD 治疗 1 周（如果适用，包括药物和刺激）。比较 ODT 和 DBS+ODT 组之间的 UPDRS-III“关闭”项目评分（n=28）；对具有显著组间差异的项目进行了进一步分析。
与接受 DBS+ODT 的患者相比，接受 ODT 的患者的 UPDRS-III“关闭”休息震颤评分从基线到 24 个月的变化更差（ = 0.002）。从基线到 24 个月，DBS+ODT 对休息震颤的斜率在“关闭”和“开启”治疗时均有利（<0.001， = 0.003）。与接受 DBS+ODT 的患者相比，更多接受 ODT 的患者在以前无震颤的肢体中出现新的震颤（ = 0.001）。
这些结果表明，早期 PD 中的 DBS 可能会减缓震颤的进展。需要在更大的队列中进行进一步的研究，并且这些发现将在食品和药物管理局批准的、III 期、关键性、多中心临床试验中进行测试，该试验评估了早期 PD 中的 DBS。
本研究提供了 II 级证据，表明对于早期 PD 患者，DBS 可能会减缓震颤的进展。
