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导航重复经颅磁刺激改善胶质瘤患者术后轻瘫的预后——一项随机双盲试验。

Navigated repetitive transcranial magnetic stimulation improves the outcome of postsurgical paresis in glioma patients - A randomized, double-blinded trial.

作者信息

Ille Sebastian, Kelm Anna, Schroeder Axel, Albers Lucia E, Negwer Chiara, Butenschoen Vicki M, Sollmann Nico, Picht Thomas, Vajkoczy Peter, Meyer Bernhard, Krieg Sandro M

机构信息

Department of Neurosurgery, Technical University of Munich, Germany, School of Medicine, Klinikum Rechts der Isar, Germany; TUM Neuroimaging Center, Technical University of Munich, Germany, School of Medicine, Klinikum Rechts der Isar, Germany.

Department of Neurosurgery, Technical University of Munich, Germany, School of Medicine, Klinikum Rechts der Isar, Germany.

出版信息

Brain Stimul. 2021 Jul-Aug;14(4):780-787. doi: 10.1016/j.brs.2021.04.026. Epub 2021 May 11.

Abstract

BACKGROUND

Navigated repetitive transcranial magnetic stimulation (nrTMS) is effective therapy for stroke patients. Neurorehabilitation could be supported by low-frequency stimulation of the non-damaged hemisphere to reduce transcallosal inhibition.

OBJECTIVE

The present study examines the effect of postoperative nrTMS therapy of the unaffected hemisphere in glioma patients suffering from acute surgery-related paresis of the upper extremity (UE) due to subcortical ischemia.

METHODS

We performed a randomized, sham-controlled, double-blinded trial on patients suffering from acute surgery-related paresis of the UE after glioma resection. Patients were randomly assigned to receive either low frequency nrTMS (1 Hz, 15 min) or sham stimulation directly before physical therapy for 7 consecutive days. We performed primary and secondary outcome measures on day 1, on day 7, and at a 3-month follow-up (FU). The primary endpoint was the change in Fugl-Meyer Assessment (FMA) at FU compared to day 1 after surgery.

RESULTS

Compared to the sham stimulation, nrTMS significantly improved outcomes between day 1 and FU based on the FMA (mean [95% CI] +31.9 [22.6, 41.3] vs. +4.2 [-4.1, 12.5]; P = .001) and the National Institutes of Health Stroke Scale (NIHSS) (-5.6 [-7.5, -3.6] vs. -2.4 [-3.6, -1.2]; P = .02). To achieve a minimal clinically important difference of 10 points on the FMA scale, the number needed to treat is 2.19.

CONCLUSION

The present results show that patients suffering from acute surgery-related paresis of the UE due to subcortical ischemia after glioma resection significantly benefit from low-frequency nrTMS stimulation therapy of the unaffected hemisphere.

CLINICAL TRIAL REGISTRATION

Local institutional registration: 12/15; ClinicalTrials.gov number: NCT03982329.

摘要

背景

导航重复经颅磁刺激(nrTMS)是治疗中风患者的有效方法。对未受损半球进行低频刺激可减少胼胝体抑制,从而支持神经康复。

目的

本研究探讨nrTMS术后治疗对因皮层下缺血导致急性手术相关上肢麻痹(UE)的胶质瘤患者未受影响半球的作用。

方法

我们对胶质瘤切除术后患有急性手术相关UE麻痹的患者进行了一项随机、假对照、双盲试验。患者被随机分配在物理治疗前连续7天接受低频nrTMS(1Hz,15分钟)或假刺激。我们在第1天、第7天和3个月随访(FU)时进行了主要和次要结局测量。主要终点是与术后第1天相比,FU时Fugl-Meyer评估(FMA)的变化。

结果

与假刺激相比,基于FMA(平均值[95%CI]+31.9[22.6,41.3]对+4.2[-4.1,12.5];P = 0.001)和美国国立卫生研究院卒中量表(NIHSS)(-5.6[-7.5,-3.6]对-2.4[-3.6,-1.2];P = 0.02),nrTMS在第1天和FU之间显著改善了结局。为了在FMA量表上实现10分的最小临床重要差异,所需治疗人数为2.19。

结论

目前的结果表明,因胶质瘤切除术后皮层下缺血导致急性手术相关UE麻痹的患者,从未受影响半球的低频nrTMS刺激治疗中显著获益。

临床试验注册

当地机构注册:12/15;ClinicalTrials.gov编号:NCT03982329。

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