在随机交叉双盲评估中，脊髓刺激未能改善帕金森病症状。

Spinal Cord Stimulation Failed to Improve Parkinson's Disease Symptoms in Randomized Crossover Double-Blinded Evaluation.

作者信息

Carra Rafael Bernhart, Garcia Lucas Ávila Lessa, Menezes Janaina Reis, Capato Tamine, Santos Francielle, Barbosa Egberto Reis, Duarte Kleber Paiva, Godinho Fabio, Teixeira Manoel Jacobsen, de Andrade Daniel Ciampi, Cury Rubens Gisbert

机构信息

Department of Neurology, Movement Disorders Center, School of Medicine, University of São Paulo, São Paulo, Brazil.

Radiology Department, School of Medicine, University of São Paulo, São Paulo, Brazil.

出版信息

Mov Disord. 2025 Jul;40(7):1279-1290. doi: 10.1002/mds.30187. Epub 2025 Apr 2.

DOI:10.1002/mds.30187

PMID:40172032

Abstract

BACKGROUND

Epidural electrical spinal cord stimulation has been studied for more than a decade for Parkinson's disease symptoms, but compelling evidence for its effectiveness is still lacking.

OBJECTIVE

The aim of this study was to evaluate the effectiveness of spinal cord stimulation in Parkinson's disease.

METHODS

Participants had Parkinson's disease diagnosis, gait impairment and freezing of gait, and no pain. Paddle electrodes were implanted at the T2-T4 level. After 6 months of parameter selection, subthreshold and sham stimulation were compared through a double-blinded randomized evaluation and further compared with suprathreshold stimulation. A second 6- to 8-month period of parameter adjustment and a final long-term open evaluation followed. Outcomes were determined via Timed Up and Go (TUG), Movement Disorders Society Unified Parkinson's Disease Scale (MDS UPDRS) Part III, Mini BESTest, New Freezing of Gait Questionnaire, Parkinson's Disease Questionnaire 39, Fall Efficiency Scale International, and accelerometer-based gait analysis. Functional magnetic resonance imaging was also performed during the double-blind evaluation period.

RESULTS

This study was terminated for futility after eight patients underwent implantation and seven completed double-blind evaluations. TUG duration ON stimulation was median 11.59 (19.7-10.9) seconds on medication and 24.49 (48.1-13.7) seconds off medication, which was not statistically different from sham with 12.38 (13.7-11.8) and 16.93 (30-14.4) seconds on respective medication status. Likewise, no significant differences were found for MDS UPDRS Part III scores, respectively, ON active stimulation for 29 (33.5-23) and 42 (51-40) seconds and on sham 28 (30.5-26) and 50 (51.5-44) seconds. No effect from stimulation was identified in any other outcome.

CONCLUSIONS

摘要

背景

硬膜外脊髓电刺激治疗帕金森病症状已研究了十多年，但仍缺乏其有效性的确凿证据。

目的

本研究旨在评估脊髓刺激对帕金森病的有效性。

方法

参与者患有帕金森病，存在步态障碍和步态冻结，且无疼痛。将平板电极植入T2 - T4水平。在6个月的参数选择期后，通过双盲随机评估比较阈下刺激和假刺激，并进一步与阈上刺激进行比较。随后是第二个6至8个月的参数调整期和最终的长期开放评估。通过计时起立行走测试（TUG）、运动障碍协会统一帕金森病评定量表（MDS UPDRS）第三部分、Mini BESTest、新步态冻结问卷、帕金森病问卷39、国际跌倒效能量表以及基于加速度计的步态分析来确定结果。在双盲评估期还进行了功能磁共振成像。

结果

在8例患者接受植入且7例完成双盲评估后，该研究因无效而终止。刺激开启时，TUG持续时间在服药状态下中位数为11.59（19.7 - 10.9）秒，未服药状态下为24.49（48.1 - 13.7）秒，与假刺激相比无统计学差异，假刺激在相应服药状态下分别为12.38（13.7 - 11.8）秒和16.93（30 - 14.4）秒。同样，MDS UPDRS第三部分得分在阈上刺激开启29（33.5 - 23）秒和42（51 - 40）秒时与假刺激开启28（30.5 - 26）秒和50（51.5 - 44）秒时相比，也未发现显著差异。在任何其他结果中均未发现刺激有效果。