Randomized double-blind sham-controlled trial of thalamic versus GPi stimulation in patients with severe medically refractory Gilles de la Tourette syndrome
Randomized double-blind sham-controlled trial of thalamic versus GPi stimulation in patients with severe medically refractory Gilles de la Tourette syndrome
复制标题
丘脑与 GPi 刺激治疗严重难治性抽动秽语综合征患者的随机双盲假对照试验
DOI：
10.1016/j.brs.2021.04.004
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发表时间：
2021
影响因子：
7.7
通讯作者：
J. Krauss
中科院分区：
文献类型：
--
作者：
K. Müller;N. Szejko;A. Saryyeva;C. Schrader;D. Krueger;A. Horn;A. Kühn;J. Krauss
背景脑深部电刺激（DBS）治疗抽动-秽语综合征（GTS）的疗效及最佳靶点的选择尚无充分的资料（中央-腹-口内肌，CM-Voi）对比后腹外侧苍白球内肌（pvl GPi））对比假刺激，方法在这项随机双盲假刺激对照试验（RCT）中，10例患者（3名女性，平均年龄= 29.4 ± 10.2 SD，范围18-47）经历三个盲期，每个盲期持续三个月，包括（i）假手术，（ii）pvl GPi（on-GPi），和（iii）丘脑刺激（对塔尔），然后由一个开放的不受控制的长期随访（长达9年），单独确定的目标和刺激settings.ResultsNine患者完成了随机对照试验。在组水平上，与基线相比，GPi-而不是thal-导致抽搐显著减少，但对先兆冲动和精神共病没有影响。目标的直接比较导致不一致或阴性（与假手术相比）结果。在随访期间，我们发现在组水平上抽搐、合并症和生活质量没有改善，然而，单个患者从丘脑DBS中持续获益。术后末次随访89.9个月（平均）时，50%的患者停用DBS。结论pvl GPi DBS的初始效果优于丘脑（CM-Voi）DBS，且具有上级效果。虽然有一半的患者停止治疗，但单个患者即使在多年后也能从丘脑DBS中受益。结果很可能受到各种因素的影响，而不仅仅是抽搐严重程度的变化。
BackgroundThere are still no sufficient data regarding the use of deep brain stimulation (DBS) in Gilles de la Tourette syndrome (GTS) and no agreement on optimal target.ObjectiveTo compare efficacy and safety of bilateral DBS of thalamus (centromedian-ventro-oral internus, CM-Voi) versus posteroventral lateral globus pallidus internus (pvl GPi)) versus sham stimulation, and baseline in severe medically refractory GTS.MethodsIn this randomized double-blind sham stimulation-controlled trial (RCT), 10 patients (3 women, mean age = 29.4 ± 10.2 SD, range 18–47) underwent three blinded periods each lasting three months including (i) sham, (ii) pvl GPi (on-GPi), and (iii) thalamic stimulation (on-thal) followed by an open uncontrolled long-term follow-up (up to 9 years) with individually determined target and stimulation settings.ResultsNine patients completed the RCT. At group level, on-GPi – but not on-thal – resulted in a significant tic reduction compared to baseline, but had no effect on premonitory urges and psychiatric comorbidities. Direct comparisons of targets resulted in inconsistent or negative (compared to sham) findings. During follow-up, we found no improvement of tics, comorbidities, and quality of life at group level, however, single patients benefitted continuously from thalamic DBS. At last follow-up 89.9 months (mean) after surgery, 50% of patients had discontinued DBS. Hardware infections occurred in 3/10 patients.ConclusionOur data suggest that the initial effect of pvl GPi DBS is superior to thalamic (CM-Voi) DBS. While half of the patients discontinued treatment, single patients benefitted from thalamic DBS even after years. It is likely that outcome is influenced by various factors beyond the mere change in tic severity.
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影响因子：
--
作者：
W. Goodman;L. Price;S. Rasmussen;C. Mazure;Roberta L. Fleischmann;Candy L. Hill;G. Heninger;D. Charne
通讯作者：
W. Goodman;L. Price;S. Rasmussen;C. Mazure;Roberta L. Fleischmann;Candy L. Hill;G. Heninger;D. Charne
影响因子：
5.7
作者：
Horn, Andreas;Kuehn, Andrea A.
通讯作者：
Kuehn, Andrea A.
影响因子：
7.7
作者：
Baldermann, Juan Carlos;Schueller, Thomas;Kuhn, Jens
通讯作者：
Kuhn, Jens
影响因子：
29
作者：
Martinez-Ramirez, Daniel;Jimenez-Shahed, Joohi;Okun, Michael S.
通讯作者：
Okun, Michael S.
影响因子：
11.2
作者：
Neumann, Wolf-Julian;Huebl, Julius;Kuehn, Andrea A.
通讯作者：
Kuehn, Andrea A.