Bjerknes Silje, Toft Mathias, Konglund Ane E, Pham Uyen, Waage Trine Rygvold, Pedersen Lena, Skjelland Mona, Haraldsen Ira, Andersson Stein, Dietrichs Espen, Skogseid Inger Marie
Department of Neurology Oslo University Hospital Oslo Norway.
Institute of Clinical Medicine University of Oslo Oslo Norway.
Mov Disord Clin Pract. 2018 May 8;5(3):296-305. doi: 10.1002/mdc3.12621. eCollection 2018 May-Jun.
Subthalamic nucleus deep brain stimulation improves motor symptoms and fluctuations in advanced Parkinson's disease, but the degree of clinical improvement depends on accurate anatomical electrode placement. Methods used to localize the sensory-motor part of the nucleus vary substantially. Using microelectrode recordings, at least three inserted microelectrodes are needed to obtain a three-dimensional map. Therefore, multiple simultaneously inserted microelectrodes should provide better guidance than single sequential microelectrodes. We aimed to compare the use of multiple simultaneous versus single sequential microelectrode recordings on efficacy and safety of subthalamic nucleus stimulation.
Sixty patients were included in this double-blind, randomized study, 30 in each group. Primary outcome measures were the difference from baseline to 12 months in the MDS-UPDRS motor score (part III) in the off-medication state and quality of life using the Parkinson's Disease Questionnaire-39 (PDQ-39) scores.
The mean reduction of the MDS-UPDRS III off score was 35 (SD 12) in the group investigated with multiple simultaneous microelectrodes compared to 26 (SD 10) in the single sequential microelectrode group ( 0.004). The PDQ-39 Summary Index did not differ between the groups, but the domain scores activities of daily living and bodily discomfort improved significantly more in the multiple microelectrodes group. The frequency of serious adverse events did not differ significantly.
After 12 months of subthalamic nucleus stimulation, the multiple microelectrodes group had a significantly greater improvement both in MDS-UPDRS III off score and in two PDQ-39 domains. Our results may support the use of multiple simultaneous microelectrode recordings.
http://ClinicalTrials.gov Identifier: NCT00855621 (first received March 3, 2009).
丘脑底核深部脑刺激可改善晚期帕金森病的运动症状和症状波动，但临床改善程度取决于电极在解剖学上的精确放置。用于定位丘脑底核感觉运动部分的方法差异很大。使用微电极记录时，至少需要插入三根微电极才能获得三维图谱。因此，多个微电极同时插入应比单个微电极依次插入提供更好的指导。我们旨在比较多个微电极同时插入与单个微电极依次插入在丘脑底核刺激的疗效和安全性方面的差异。
本双盲随机研究纳入了60例患者，每组30例。主要结局指标为非用药状态下从基线到12个月时MDS-UPDRS运动评分（第三部分）的差异以及使用帕金森病问卷-39（PDQ-39）评分评估的生活质量。
多个微电极同时插入组的MDS-UPDRS III期非用药状态下评分平均降低35（标准差12），而单个微电极依次插入组为26（标准差10）（P=0.004）。两组的PDQ-39综合指数无差异，但多个微电极组在日常生活活动和身体不适领域的评分改善更为显著。严重不良事件的发生率无显著差异。
丘脑底核刺激12个月后，多个微电极组在MDS-UPDRS III期非用药状态下评分及两个PDQ-39领域均有显著更大改善。我们的结果可能支持使用多个微电极同时记录。
http://ClinicalTrials.gov 标识符：NCT00855621（首次收到日期为2009年3月3日）。
