Engelhardt Melina, Grittner Ulrike, Krieg Sandro, Picht Thomas
Department of Neurosurgery, Charité - Universitätsmedizin, corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Charitéplatz 1, Berlin, 10117, Germany.
Einstein Center for Neurosciences, Charité - Universitätsmedizin, corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Charitéplatz 1, Berlin, 10117, Germany.
Trials. 2023 Oct 4;24(1):638. doi: 10.1186/s13063-023-07640-2.
The extent of resection of glioma is one of the most important predictors of the survival duration of patients after surgery. The presence of eloquent areas within or near a tumor often limits resection, as resection of these areas would result in functional loss and reduced quality of life. The aim of this randomized, triple-blind, sham-controlled study is to investigate the capability of repetitive navigated transcranial magnetic stimulation (rnTMS) over the primary motor cortex to facilitate the functional reorganization of the motor network.
One hundred forty-eight patients with tumors in movement-relevant areas will be included in this randomized, sham-controlled, bicentric, triple-blind clinical trial. Patients considered at high risk for postoperative motor deficits according to an initial nTMS assessment will receive inhibitory rnTMS at 1 Hz for 30 min followed by a short motor training of 10 min. Stimulation will be applied to the fiber endings of the corticospinal tract closest to the tumor based on individualized tractography. Stimulation will be performed twice daily for each 30 min for 5-28 days depending on the individually available time between study inclusion and surgery. The intervention is controlled by a sham stimulation group (1:1 randomization), where a plastic adapter will be placed on the coil. We expect a comparable or better motor status 3 months postoperatively as measured by the British Medical Research Council (BMRC) score for the affected upper extremity (non-inferiority) and a higher rate of gross total resections (superiority) in the rnTMS compared to the sham group.
The generated reorganization of the brain's areas for motor function should allow a more extensive and safer removal of the tumor while preserving neurological and motor function. This would improve both survival and quality of life of our patients.
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胶质瘤的切除范围是患者术后生存时间的最重要预测因素之一。肿瘤内部或附近存在明确功能区常常会限制切除范围，因为切除这些区域会导致功能丧失和生活质量下降。这项随机、三盲、假手术对照研究的目的是探究经颅磁刺激（rnTMS）对初级运动皮层的重复导航刺激促进运动网络功能重组的能力。
148例肿瘤位于与运动相关区域的患者将被纳入这项随机、假手术对照、双中心、三盲临床试验。根据初始经颅磁刺激（nTMS）评估被认为术后运动功能缺损风险高的患者将接受1赫兹的抑制性rnTMS刺激30分钟，随后进行10分钟的简短运动训练。基于个体化纤维束成像，刺激将施加于最接近肿瘤的皮质脊髓束纤维末端。根据纳入研究到手术之间的个体可用时间，刺激将每天进行两次，每次30分钟，持续5 - 28天。干预由假刺激组（1:1随机分组）控制，其中将在磁体线圈上放置一个塑料适配器。我们预计，与假手术组相比，术后3个月通过英国医学研究委员会（BMRC）评分评估患侧上肢运动状态相当或更好（非劣效性），且rnTMS组大体全切率更高（优越性）。
大脑运动功能区域产生的重组应能在保留神经和运动功能的同时更广泛、安全地切除肿瘤。这将改善我们患者的生存和生活质量。
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