neuronavigation

神经导航
  • 文章类型: Journal Article
    评价神经导航辅助立体定向钻孔引流术与开颅手术治疗老年脑出血(ICH)的疗效。这是一个随机的,控制,盲终点临床研究。在我们神经外科治疗的大量脑出血的老年患者,术前没有形成脑疝,所有患者均接受了神经外科手术.将患者随机分为两组:微创手术(MIS)组,接受了神经导航辅助立体定向钻孔引流,开颅血肿清除术(CHRS)组。患者特征,手术麻醉方法,手术持续时间,术中出血量,ICU住院时间并发症,比较两组治疗后90天改良Rankin量表(mRS)评分。对收集的数据进行统计分析。共有67名患者被随机分配,MIS组33例(49.25%),CHRS组34例(50.75%)。与CHRS组相比,MIS集团有优势,包括局部麻醉,手术时间较短,术中出血少,ICU住院时间较短,并发症少(P<0.05)。MIS组在90天时患者预后显著改善(mRS0-3)。然而,两组患者的住院时间和90d生存率比较,差异均无统计学意义(P>0.05)。对于没有脑疝的大量ICH的老年患者,立体定向钻孔引流是一种简单的外科手术,可以在局部麻醉下进行。用这种方法治疗的患者似乎比开颅手术治疗的患者有更好的结果。在临床实践中,神经导航辅助立体定向钻孔引流术推荐用于手术治疗大量ICH无脑疝的老年患者.临床试验登记号:NCT04686877。
    To evaluate the efficacy of neuronavigation-assisted stereotactic drilling drainage compared with that of craniotomy in the treatment of massive intracerebral haemorrhage (ICH) in elderly patients. This was a randomized, controlled, blind endpoint clinical study. Elderly patients with massive ICH treated at our neurosurgery department, without the formation of brain herniation preoperatively, all underwent neurosurgical intervention. Patients were randomly assigned to two groups: the minimally invasive surgery (MIS) group, which received neuronavigation-assisted stereotactic drilling drainage, and the craniotomy haematoma removal surgery (CHRS) group. Patient characteristics, surgical anaesthesia methods, surgery duration, intraoperative bleeding volume, duration of ICU stay duration of hospital stay, complications, and modified Rankin scale (mRS) scores at 90 days posttreatment were compared between the two groups. Statistical analysis was performed on the collected data. A total of 67 patients were randomly assigned, with 33 (49.25%) in the MIS group and 34 (50.75%) in the CHRS group. Compared with the CHRS group, the MIS group had advantages, including the use of local anaesthesia, shorter surgery duration, less intraoperative bleeding, shorter ICU stay, and fewer complications (P < 0.05). The MIS group had a significantly improved patient prognosis at 90 days (mRS 0-3). However, there were no significant differences in hospital stay or 90-day survival rate between the two groups (P > 0.05). For elderly patients with massive ICH without brain herniation, stereotactic drilling drainage is a simple surgical procedure that can be performed under local anaesthesia. Patients treated with this approach seem to have better outcomes than those treated with craniotomy. In clinical practice, neuronavigation-assisted stereotactic drilling drainage is recommended for surgical treatment in elderly patients with massive ICH without brain herniation.Clinical trial registration number: NCT04686877.
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  • 文章类型: Journal Article
    背景:在评估3.0T术中磁共振成像(iMRI)结合多模态功能MRI(fMRI)指导在功能区胶质瘤切除中的临床实用性和安全性时,我们进行了一项研究。
    方法:在120例新诊断的功能区胶质瘤患者中,每组60例:iMRI和fMRI整合组及常规导航组。对切除程度(EOR)进行组间比较,基于Karnofsky表现状态的术前和术后日常生活活动,手术持续时间,术后颅内感染率。
    结果:与常规导航组相比,具有iMRI和fMRI的集成导航组在肿瘤切除方面显着改善(完全切除率:85.0%vs.60.0%,P=0.006)和术后生活自理能力评分(Karnofsky评分)(中位数±四分位数范围:90±25vs.80±30,P=0.013)。此外,尽管使用iMRI和fMRI的集成导航组比常规导航组需要更长的手术时间(平均值±标准偏差:411.42±126.4分钟vs.295.97±96.48min,P<0.0001),术后颅内感染的总发生率无显著组间差异(16.7%vs.18.3%,P=0.624)。
    结论:3.0TiMRI与多模态fMRI指导相结合,可有效切除肿瘤,同时神经损伤最小。
    BACKGROUND: In assessing the clinical utility and safety of 3.0 T intraoperative magnetic resonance imaging (iMRI) combined with multimodality functional MRI (fMRI) guidance in the resection of functional area gliomas, we conducted a study.
    METHODS: Among 120 patients with newly diagnosed functional area gliomas who underwent surgical treatment, 60 were included in each group: the integrated group with iMRI and fMRI and the conventional navigation group. Between-group comparisons were made for the extent of resection (EOR), preoperative and postoperative activities of daily living based on the Karnofsky performance status, surgery duration, and postoperative intracranial infection rate.
    RESULTS: Compared to the conventional navigation group, the integrated navigation group with iMRI and fMRI exhibited significant improvements in tumor resection (complete resection rate: 85.0% vs. 60.0%, P = 0.006) and postoperative life self-care ability scores (Karnofsky score) (median ± interquartile range: 90 ± 25 vs. 80 ± 30, P = 0.013). Additionally, although the integrated navigation group with iMRI and fMRI required significantly longer surgeries than the conventional navigation group (mean ± standard deviation: 411.42 ± 126.4 min vs. 295.97 ± 96.48 min, P<0.0001), there was no significant between-group difference in the overall incidence of postoperative intracranial infection (16.7% vs. 18.3%, P = 0.624).
    CONCLUSIONS: The combination of 3.0 T iMRI with multimodal fMRI guidance enables effective tumor resection with minimal neurological damage.
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  • 文章类型: Case Reports
    由于独特的皮质静脉引流模式没有鼻窦引流,筛骨硬膜动静脉瘘(DAVF)是罕见的脑血管病变,具有脑出血和神经功能缺损的高风险。已发现在各种DAVF治疗方案中,与血管内治疗相比,手术干预具有较低的并发症发生率和更令人满意的闭塞率。眶上锁孔额下入路是解决eDAVFs前窝血管病变的微创和适当的手术技术之一。我们描述了两个男人,年龄分别为60岁和71岁,他们接受了这种手术干预以治疗无症状的CognardIV型eDAVF。在术中神经导航的帮助下,通过分离的瘘管点和骨骼化完成了完全的闭塞。因此,我们建议,治疗eDAVFs的合适手术方法是使用眶上锁孔额下入路。
    Due to a unique cortical venous drainage pattern without sinus drainage, ethmoidal dural arteriovenous fistula (DAVF) are uncommon cerebral vascular lesions that carry a high risk of brain bleeding and neurologic deficit. Surgical intervention has been found to have a lower complication rate and a more satisfactory obliteration rate than endovascular treatment among the various DAVF treatment options. The supraorbital keyhole subfrontal approach is one of the least invasive and appropriate surgical techniques for addressing the anterior fossa vascular lesion in eDAVFs. We describe two men, ages 60 and 71, who underwent this surgical intervention to treat asymptomatic Cognard type IV eDAVFs. Complete obliteration with a detached fistulous point and skeletonization was accomplished with the aid of intraoperative neuronavigation. Thus, we suggest that a suitable surgical method for the treatment of eDAVFs would be to use a supraorbital keyhole subfrontal approach.
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  • 文章类型: Journal Article
    垂体手术的发展使其成为一种安全有效的治疗方法;尽管如此,肿瘤切除不完全和脑脊液(CSF)渗漏的可能性仍然存在.近年来,神经导航辅助的垂体神经内分泌肿瘤(PitNET)切除术引起了越来越多的关注。然而,目前缺乏对神经导航辅助垂体瘤切除术有效性的全面定量评价。我们旨在评估在PitNET切除术中使用或不使用基于图像的神经导航的疗效和并发症。
    通过搜索PubMed,EMBASE,科克伦图书馆,WebofScience,和Scopus从开始到2024年5月1日的英语,以确定任何报告接受神经导航辅助PitNET切除术的患者的总体全切除(GTR)或术后并发症的研究,不包括少于五个科目的会议摘要和研究。我们还在数据库中检索了以前的系统综述和其他相关出版物的参考文献列表。我们回顾并分析了研究PitNET切除术中神经导航的手术效果和并发症的研究。研究质量通过纽卡斯尔-渥太华量表进行评估,发表偏倚采用漏斗图评价。审查经理5.3被用于荟萃分析。结果表示为图像辅助技术对GTR和并发症发生率的比值比(OR)和95%置信区间(CI)。
    从上述数据库中获得了总共42种符合既定搜索标准的出版物,所有这些与纽卡斯尔-渥太华量表得分≥6★。在包括的出版物中,37项研究表明,基于图像的神经导航对GTR的OR为2.29(95%CI:2.02-2.60,P<0.00001,I2=24%)。其他五项研究比较了神经导航组(实验组)和非神经导航组(对照组),表现出高异质性(I2=91%)。经过敏感性分析,结果表明,神经导航组的CSF泄漏率略低于非神经导航组(OR:0.84,95%CI:0.73-0.97,P=0.01,I2=43%)。
    根据现有数据,神经导航辅助PitNET切除可以提高GTR的发生率,降低术后并发症的发生率。我们的结果为今后临床实践中PitNET切除手术方法的选择提供了参考。
    UNASSIGNED: The advancement of pituitary surgery has rendered it a secure and efficient treatment method; nevertheless, the potential for incomplete tumor removal and cerebrospinal fluid (CSF) leak remains. Neuronavigation-assisted pituitary neuroendocrine tumor (PitNET) resections have been driving a rising number of attentions in recent years. However, there is currently a lack of comprehensive quantitative evaluation of the effectiveness of neuronavigation-assisted pituitary tumor resection. We aimed to assess the curative effects and complications with or without the use of an image-based neuronavigation in PitNET resection.
    UNASSIGNED: A systematic review and meta-analysis was performed by searching PubMed, EMBASE, Cochrane Library, Web of Science, and Scopus from inception until May 1, 2024 in English to identify any studies reporting gross total resection (GTR) or postoperative complications in patients who underwent neuronavigation-assisted PitNET resection, excluding conference abstracts and studies with fewer than five subjects. We also searched the reference lists of previous systematic reviews and other relevant publications in databases. We reviewed and analyzed the studies that investigated the operative effects and complications of neuronavigation in PitNET resection. Study quality was assessed by the Newcastle-Ottawa scale, and publication bias was evaluated by funnel plot. Review manager 5.3 was employed for meta-analysis. The results were expressed as odds ratio (OR) with 95% confidence interval (CI) of image-assisted techniques for the incidence of GTR and complications.
    UNASSIGNED: A total of 42 publications that fulfilled the established searching criteria were obtained from the above-mentioned databases, all of which with the Newcastle-Ottawa Scale scores ≥ six ★. Among the included publications, 37 studies indicated that the OR of image-based neuronavigation was 2.29 (95% CI: 2.02-2.60, P<0.00001, I2=24%) for GTR. The other five studies compared the neuronavigation group (experimental group) and non-neuronavigation group (control group), exhibiting high heterogeneity (I2=91%). After sensitivity analysis, the results showed that the rate of the CSF leak of the neuronavigation group was slightly lower than that of the non-neuronavigation group (OR: 0.84, 95% CI: 0.73-0.97, P=0.01, I2=43%).
    UNASSIGNED: According to the existing data, neuronavigation-assisted PitNET resection can increase the rates of GTR and reduce the incidence of postoperative complications. Our results provide a reference for the selection of surgical methods for PitNET resection in future clinical practice.
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  • 文章类型: Dataset
    混合现实导航(MRN)技术正在成为神经外科中日益重要和有趣的话题。MRN使神经外科医生能够通过互动方式“看穿”头部,融合了虚拟和物理世界元素的混合可视化环境。提供身临其境的,直观,并为颅内病变的术前和术中干预提供可靠的指导,MRN展示了其作为标准神经导航系统的经济高效且用户友好的替代方案的潜力。然而,MRN系统的临床研究和开发面临挑战:在有限的时间内招募足够数量的患者是困难的,低成本收购,商用,具有医学意义的头部幻影同样具有挑战性。为了加快新型MRN系统的开发并克服这些障碍,该研究提供了一个为神经外科MRN系统开发和测试而设计的数据集.它包括来自19例颅内病变患者的CT和MRI数据,以及衍生的解剖结构3D模型和验证参考。该模型可在波前对象(OBJ)和立体光刻(STL)格式,支持神经外科MRN应用的创建和评估。
    Mixed reality navigation (MRN) technology is emerging as an increasingly significant and interesting topic in neurosurgery. MRN enables neurosurgeons to \"see through\" the head with an interactive, hybrid visualization environment that merges virtual- and physical-world elements. Offering immersive, intuitive, and reliable guidance for preoperative and intraoperative intervention of intracranial lesions, MRN showcases its potential as an economically efficient and user-friendly alternative to standard neuronavigation systems. However, the clinical research and development of MRN systems present challenges: recruiting a sufficient number of patients within a limited timeframe is difficult, and acquiring low-cost, commercially available, medically significant head phantoms is equally challenging. To accelerate the development of novel MRN systems and surmount these obstacles, the study presents a dataset designed for MRN system development and testing in neurosurgery. It includes CT and MRI data from 19 patients with intracranial lesions and derived 3D models of anatomical structures and validation references. The models are available in Wavefront object (OBJ) and Stereolithography (STL) formats, supporting the creation and assessment of neurosurgical MRN applications.
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  • 文章类型: Journal Article
    目的:脑血肿的准确定位和实时引导技术对于微创手术至关重要,包括微创血肿穿刺引流,以及神经内镜辅助血肿清除术.本研究旨在评估自行开发的激光引导设备在脑出血(ICH)微创手术中定位和引导血肿穿刺的准确性和安全性。
    方法:我们介绍了设备的组件及其操作程序。随后,不同头衔的外科医生使用该设备在颅骨模型上进行血肿穿刺实验,将其与徒手穿刺方法进行比较,并记录从穿刺针尖端到血肿中心的偏移距离。此外,我们报告了该装置在10例ICH患者中的应用,与神经导航系统相比,评估其准确性和安全性。
    结果:在模拟穿刺实验中,激光引导组的准确性超过徒手穿刺组,两组比较差异有统计学意义(P<0.05)。在激光制导组中,手术医师之间的穿刺准确性差异无统计学意义(P>0.05)。在临床实验中,未观察到相关手术并发症。激光引导组的偏移距离为0.61±0.18cm,而神经导航组为0.48±0.13cm。两组在偏移距离方面差异无统计学意义(P>0.05)。然而,手术时间差异有统计学意义(P<0.05),前者为35.0±10.5分钟,后者为63.8±10.5分钟。
    结论:当前的研究描述了模拟实验和临床应用的令人满意的结果,通过使用一种新型的激光引导血肿穿刺装置来实现。此外,由于它的便携性,负担能力,和简单,它在推进ICH的手术干预方面具有重要意义,特别是在欠发达地区。
    Accurate localization and real-time guidance technologies for cerebral hematomas are essential for minimally invasive procedures, including minimally invasive hematoma puncture and drainage, as well as neuroendoscopic-assisted hematoma removal. This study aims to evaluate the precision and safety of a self-developed laser-guided device in localizing and guiding hematoma punctures in minimally invasive surgery for intracerebral hemorrhage (ICH).
    We present the components of the device and its operational procedures. Subsequently, surgeons with different titles conduct hematoma puncture experiments using the device on skull models, comparing it to freehand puncture methods and recording the offset distance from the puncture needle tip to the hematoma center. Additionally, we report the application of this device in 10 patients with ICH, assessing its accuracy and safety in comparison with a neuro-navigation system.
    In simulated puncture experiments, the accuracy of the laser-guided group surpasses that of the freehand puncture group, with a significant statistical difference observed between the two groups (P < 0.05). In the laser-guided group, there is no statistically significant difference in puncture accuracy among the surgeons (P > 0.05). In clinical experiments, no relevant surgical complications were observed. The offset distance for the laser-guided group was 0.61 ± 0.18 cm, while the neuro-navigation group was 0.48 ± 0.13 cm. There was no statistically significant difference between the two groups in terms of offset distance (P > 0.05). However, there was a significant difference in surgical duration (P < 0.05), with the former being 35.0 ± 10.5 minutes and the latter being 63.8 ± 10.5 minutes.
    The current study describes satisfactory results from both simulated experiments and clinical applications, achieved through the use of a novel laser-guided hematoma puncture device. Furthermore, owing to its portability, affordability, and simplicity, it holds significant importance in advancing surgical interventions for ICH, especially in underdeveloped regions.
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  • 文章类型: Journal Article
    目的:为了评估可行性,准确度,三维(3D)结构轻型机器人辅助无框架立体定向脑活检的安全性。
    方法:5名连续患者(3名男性,2名女性)纳入本研究。患者的临床,成像,和组织学数据进行了分析,所有患者均接受了3D结构光机器人辅助无框立体定向脑活检。研究的原始和/或分析数据可从相应的作者获得。
    结果:统计结果显示,平均年龄为59.6岁(范围为40-70岁),平均目标深度为60.9毫米(范围为53.5-65.8毫米),平均径向误差为1.2±0.7mm(平均值±SD),平均深度误差为0.7±0.3mm,平均绝对尖端误差为1.5±0.6mm。计算得出的Pearson积矩相关系数(r=0.23)表明目标深度与绝对尖端误差之间没有相关性。所有活检针均顺利地按照计划轨迹放置,并在所有病例中收集诊断标本。组织病理学分析显示淋巴瘤(2例),肺腺癌(1例),多形性胶质母细胞瘤(1例),少突胶质细胞瘤(1例)。
    结论:使用3D结构光技术的表面配准是快速和精确的,因为可以实现头部和面部的百万尺度点云数据。3D结构光机器人辅助无框架立体定向脑活检是可行的,准确,和安全。
    OBJECTIVE: To assess the feasibility, accuracy, and safety of 3-dimensional (3D) structure light robot-assisted frameless stereotactic brain biopsy.
    METHODS: Five consecutive patients (3 males, 2 females) were included in this study. The patients\' clinical, imaging, and histological data were analyzed, and all patients received a 3D structure light robot-assisted frameless stereotactic brain biopsy. The raw and/or analyzed data of the study are available from the corresponding author.
    RESULTS: The statistical results showed a mean age of 59.6 years (range 40-70 years), a mean target depth of 60.9 mm (range 53.5-65.8 mm), a mean radial error of 1.2 ± 0.7 mm (mean ± SD), a mean depth error of 0.7 ± 0.3 mm, and a mean absolute tip error of 1.5 ± 0.6 mm. The calculated Pearson product-moment correlation coefficient ( r = 0.23) revealed no correlation between target depth and absolute tip error. All biopsy needles were placed in line with the planned trajectory successfully, and diagnostic specimens were harvested in all cases. Histopathological analysis revealed lymphoma (2 cases), lung adenocarcinoma (1 case), glioblastoma multiforme (1 case), and oligodendroglioma (1 case).
    CONCLUSIONS: Surface registration using the 3D structure light technique is fast and precise because of the achievable million-scale point cloud data of the head and face. 3D structure light robot-assisted frameless stereotactic brain biopsy is feasible, accurate, and safe.
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  • 文章类型: Journal Article
    目的:比较神经导航辅助脑内血肿穿刺引流术与神经内镜下血肿清除术治疗高血压脑出血的疗效。
    方法:选取2022年6月至2023年5月我院神经外科收治的91例高血压脑出血患者:观察A组47例,神经导航辅助下内镜下血肿清除术,对照组44例,手术时间,术中出血,血肿清除率,术前和术后GCS评分,美国国立卫生研究院卒中量表(NIHSS)评分,比较两组患者的mRS评分及术后并发症。
    结果:手术持续时间,B组术中出血量和血肿清除率明显低于A组(p<0.05)。相反,术前没有显著差异,术后7天,术后14天或术后1个月观察A组和B组之间的GCS或NIHSS评分或posthealingmRS评分。B组术后并发症发生率明显高于A组(p<0.05),颅内感染发生率差异最显著(p<0.05)。
    结论:神经导航辅助脑内血肿穿刺引流术和神经内镜下血肿清除术都能有效改善高血压脑出血患者的预后。神经导航的缺点是并发症的发生率明显大于其他方法,临床上应加强术后护理和并发症的预防。
    OBJECTIVE: To compare neuronavigation-assisted intracerebral hematoma puncture and drainage with neuroendoscopic hematoma removal for treatment of hypertensive cerebral hemorrhage.
    METHODS: Ninety-one patients with hypertensive cerebral hemorrhage admitted to our neurosurgery department from June 2022 to May 2023 were selected: 47 patients who underwent endoscopic hematoma removal with the aid of neuronavigation in observation Group A and 44 who underwent intracerebral hematoma puncture and drainage in control Group B. The duration of surgery, intraoperative bleeding, hematoma clearance rate, pre- and postoperative GCS score, National Institutes of Health Stroke Scale (NIHSS) score, mRS score and postoperative complications were compared between the two groups.
    RESULTS: The duration of surgery, intraoperative bleeding and hematoma clearance were significantly lower in Group B than in Group A (p < 0.05). Conversely, no significant differences in the preoperative, 7-day postoperative, 14-day postoperative or 1-month postoperative GCS or NIHSS scores or the posthealing mRS score were observed between Groups A and B. However, the incidence of postoperative complications was significantly greater in Group B than in Group A (p < 0.05), with the most significant difference in incidence of intracranial infection (p < 0.05).
    CONCLUSIONS: Both neuronavigation-assisted intracerebral hematoma puncture and drainage and neuroendoscopic hematoma removal are effective at improving the outcome of patients with hypertensive cerebral hemorrhage. The disadvantage of neuronavigation is that the incidence of complications is significantly greater than that of other methods; postoperative care and prevention of complications should be strengthened in clinical practice.
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  • 文章类型: Journal Article
    解决传统神经外科导航系统的高成本和复杂性,这项研究探讨了简化的可行性和准确性,基于激光十字准线模拟器(LCS)的高性价比混合现实导航(MRN)系统。提出了一种新的自动配准方法,具有共面激光发射器和可识别的目标模式。该工作流程已集成到Microsoft的HoloLens-2中以进行实际应用。该研究通过使用真人大小的3D打印头模评估系统的精度,基于来自19例颅内病变患者(女性/男性:7/12,平均年龄:54.4±18.5岁)的计算机断层扫描(CT)或磁共振成像(MRI)数据。每例使用六至七个CT/MRI可见头皮标记作为参考点。LCS-MRN的准确性通过基于界标和基于病变的分析进行评估,使用目标配准误差(TRE)和骰子相似系数(DSC)等指标。该系统展示了在所有病例中观察颅内结构的沉浸能力。对124个地标的分析表明,TRE为3.0±0.5毫米,在不同的手术位置一致。0.83±0.12的DSC与病变体积显着相关(Spearmanrho=0.813,p<0.001)。因此,LCS-MRN系统是神经外科计划的可行工具,突出了它的低用户依赖性,成本效益,和准确性,具有未来临床应用增强的前景。
    Addressing conventional neurosurgical navigation systems\' high costs and complexity, this study explores the feasibility and accuracy of a simplified, cost-effective mixed reality navigation (MRN) system based on a laser crosshair simulator (LCS). A new automatic registration method was developed, featuring coplanar laser emitters and a recognizable target pattern. The workflow was integrated into Microsoft\'s HoloLens-2 for practical application. The study assessed the system\'s precision by utilizing life-sized 3D-printed head phantoms based on computed tomography (CT) or magnetic resonance imaging (MRI) data from 19 patients (female/male: 7/12, average age: 54.4 ± 18.5 years) with intracranial lesions. Six to seven CT/MRI-visible scalp markers were used as reference points per case. The LCS-MRN\'s accuracy was evaluated through landmark-based and lesion-based analyses, using metrics such as target registration error (TRE) and Dice similarity coefficient (DSC). The system demonstrated immersive capabilities for observing intracranial structures across all cases. Analysis of 124 landmarks showed a TRE of 3.0 ± 0.5 mm, consistent across various surgical positions. The DSC of 0.83 ± 0.12 correlated significantly with lesion volume (Spearman rho = 0.813, p < 0.001). Therefore, the LCS-MRN system is a viable tool for neurosurgical planning, highlighting its low user dependency, cost-efficiency, and accuracy, with prospects for future clinical application enhancements.
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  • 文章类型: Randomized Controlled Trial
    背景:间歇性theta脉冲串刺激(iTBS)是一种用于抑郁症的新型重复经颅磁刺激(rTMS)。然而,其在青少年和青少年重度抑郁症(AYA-MDD)中的疗效和安全性尚未得到很好的研究,特别是当应用结合神经导航靶向和加速iTBS的策略时。
    方法:在本研究中,90名患者被随机分配到每天两次(两次600脉冲疗程,间隔10分钟,n=31),每天一次(一次600脉冲,n=29)或假iTBS(无脉冲,n=30)组治疗10天。主要结果指标是汉密尔顿抑郁量表(HAMD-17)上抑郁评分的变化。其他临床症状,比如焦虑,也进行了评估。
    结果:线性混合模型分析发现,在所有三组中,HAMD-17及其因子的得分均得到改善,但这些改善在各组之间没有显著差异.其他临床症状如焦虑也有所改善。在任何时间点,反应和缓解率相对较低,组间没有差异。最常见的不良事件是头痛,每天两次和每天一次组报告头痛的参与者比例明显高于假手术组。
    结论:目前的结果表明,在AYA-MDD中,在神经导航下每天两次和每天一次的iTBS是安全且耐受性良好的,但总体疗效并不优于假治疗.我们推测了几个可能的原因,例如年轻人的高安慰剂反应,iTBS脉冲不足等。
    BACKGROUND: Intermittent theta burst stimulation (iTBS) is a newer form of Repetitive Transcranial Magnetic Stimulation (rTMS) for depression. However, its efficacy and safety in adolescents and young adults with major depressive disorder (AYA-MDD) have not been well studied, especially when applied with a strategy that combines neuronavigation targeting and accelerated iTBS.
    METHODS: In this study, ninety patients were randomly assigned to twice-daily (two 600-pulse sessions spaced out by 10 min, n = 31), once-daily (one 600-pulse session, n = 29) or sham iTBS (no pulses, n = 30) groups for 10 treatment days. The primary outcome measure was the change in depression scores on the Hamilton Rating Scale for Depression (HAMD-17). Other clinical symptoms, such as anxiety, were also evaluated.
    RESULTS: Linear mixed model analysis found that scores on the HAMD-17 and its factors improved in all three groups, but these improvements did not significantly differ among groups. Other clinical symptoms such as anxiety also improved. Response and remission rates were relatively low and did not differ among groups at any time point. The most common adverse event was headache, and the proportion of participants who reported headache in the twice-daily and once-daily groups was significantly higher than that in the sham group.
    CONCLUSIONS: The current results indicated that twice-daily and once-daily iTBS under neuronavigation are safe and well tolerated in AYA-MDD, but the overall efficacy was not superior to that of sham treatment. We speculated several possible reasons such as the high placebo response of the young population, inadequate iTBS pulses and so on.
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