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

IF 7.6 1区医学 Q1 CLINICAL NEUROLOGY Movement Disorders Pub Date : 2025-04-02 DOI:10.1002/mds.30187

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

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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

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在随机交叉双盲评价中脊髓刺激未能改善帕金森病症状

背景：硬膜外脊髓电刺激治疗帕金森病已经研究了十多年，但其有效性仍然缺乏令人信服的证据。目的：本研究的目的是评估脊髓刺激对帕金森病的疗效。方法：参与者被诊断为帕金森病，步态障碍和步态冻结，无疼痛。桨状电极在T2-T4水平植入。参数选择6个月后，通过双盲随机评价比较阈下刺激和假刺激，并进一步比较阈上刺激。第二次6至8个月的参数调整和最终的长期开放评估。结果通过Timed Up and Go （TUG）、运动障碍学会统一帕金森病量表（MDS UPDRS）第三部分、Mini best、新步态冻结问卷、帕金森病问卷39、国际跌倒效率量表和基于加速度计的步态分析来确定。在双盲评估期间进行功能磁共振成像。结果：本研究在8例患者接受植入和7例患者完成双盲评估后因无效而终止。TUG持续时间中位数在给药状态下为11.59（19.7-10.9）秒，在给药状态下为24.49（48.1-13.7）秒，与假药状态下分别为12.38（13.7-11.8）秒和16.93（30-14.4）秒，差异无统计学意义。同样，MDS UPDRS第三部分评分在主动刺激29（33.5-23）和42（51-40）秒以及假刺激28（30.5-26）和50（51.5-44）秒时也没有显著差异。在其他结果中没有发现刺激的影响。结论：未发现脊髓刺激对帕金森病症状的影响。©2025国际帕金森和运动障碍学会。

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来源期刊

Movement Disorders 医学-临床神经学

CiteScore

13.30

自引率

8.10%

发文量

371

审稿时长

12 months

期刊介绍： Movement Disorders publishes a variety of content types including Reviews, Viewpoints, Full Length Articles, Historical Reports, Brief Reports, and Letters. The journal considers original manuscripts on topics related to the diagnosis, therapeutics, pharmacology, biochemistry, physiology, etiology, genetics, and epidemiology of movement disorders. Appropriate topics include Parkinsonism, Chorea, Tremors, Dystonia, Myoclonus, Tics, Tardive Dyskinesia, Spasticity, and Ataxia.