Virtual neuro-navigation system for personalized,community-based TMS

用于个性化、基于社区的 TMS 的虚拟神经导航系统

• 批准号: 10324763
• 负责人: Dennis Quangvinh Truong
• 金额: $ 45万
• 依托单位: SOTERIX MEDICAL,INC.
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-09-01 至 2023-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10324763
• 关键词: 3-Dimensional; Address; Adoption; Affect; Algorithms; Anterior; Antidepressive Agents; Area; Atlases; Award; Base of the Brain; Biological Markers; Brain; Brain region; Brain scan; Clinic; Clinical; Collaborations; Communities; Computer software; Data; Development; Devices; Disease remission; Electroconvulsive Therapy; Electroencephalography; Ensure; Equipment; FDA approved; Favorable Clinical Outcome; Feasibility Studies; Generalized seizures; Hand; Head; Human; Image; Individual; Interstitial Collagenase; Investigation; Ketamine; Left; Location; Magnetic Resonance Imaging; Magnetism; Major Depressive Disorder; Marketing; Measures; Medical; Medical center; Mental Depression; Morphology; Motor Cortex; Neuronavigation; Neurosciences; Outcome; Patients; Persons; Pharmaceutical Preparations; Phase; Picture Archiving and Communication System; Pilot Projects; Positioning Attribute; Prefrontal Cortex; Principal Investigator; Procedures; Provider; Publications; Randomized Clinical Trials; Randomized Controlled Trials; Research; Research Personnel; Resistance; Rest; Sampling; Scalp structure; Site; Standardization; Structure; Surface; Symptoms; System; Technology; Transcranial magnetic stimulation; Universities; Validation; Variant; awake; base; brain tissue; cingulate cortex; clinical decision support; clinical practice; connectome; efficacy evaluation; improved; in silico; interest; multimodality; neuropsychiatry; noninvasive brain stimulation; programs; reconstruction; repetitive transcranial magnetic stimulation; response; severe mental illness; side effect; software development; standard of care; tool; treatment-resistant depression; virtual

ABSTRACT Transcranial magnetic stimulation (TMS) is an FDA-approved treatment for treatment-resistant major depression (TRD). However, at present the approach is only partially effective, due in part to relatively ineffective targeting approaches. Over recent years, there has been increasing realization that TMS for anhedonic-like symptoms of major depressive disorder (MDD) is most effective when targeted at the region of left dorsolateral prefrontal cortex (L-DLPFC) that is maximally anti-correlated with subgenual anterior cingulate cortex (sgACC) as determined using resting-state functional connectivity MRI (rsfcfMRI). Ideal approaches for identifying this location for individual subjects, however, still depend on processing pipelines that are not FDA cleared and thus and are not accessible to the TMS treatment community. In general, 3D brain reconstructions can be analyzed using either traditional, volumetric approaches, or more recently developed surface-based approaches developed as part of the human connectome project (HCP) and leading to publication of the HCP multimodal brain atlas (HCP MMP1.0). In volumetric approaches, structurally and functionally based approaches have both been implemented. In the surface-based HCP MMP1.0 approach, structural and functional data are merged to identify functionally discrete brain parcels across individuals. Here, during phase I we will first develop an investigational software package (“TMSMap”) that will permit TMS researchers to utilize either volumetric or surface-based analytic approaches for determining MR-based personalized L-DLPFC target locations on-line, and will create a parallel off-line virtual neuro-navigation tool to permit neuro-navigated TMS even for “community” practioners without access to on-line neuro-navigation capabilities. During phase II we will create a Picture Archiving and Communication System (PACS) compliant clinic-ready version, which we evaluate in a multicenter randomized controlled trial in TMS-resistant TRD individuals. We will ensure that all device (software developed to medical standards) and data (clinical validation) requirements are complete by Phase II end, to enable pursuing either a 510(k) or de-novo submission with positive clinical outcome. The project builds both from the long-standing interest of Soterix Medical Inc.(SMI) in 1) the use of combined TMS and neuro-navigation, and 2) the development of automated targeting software for non-invasive brain stimulation; and from recent research by the principal investigator at Columbia University Irving Medical Center (CUIMC) demonstrating 1) anti-correlation of HCP MMP1.0 parcel 46 with sgACC across individuals within the HCP sample and 2) 100% response rate among TMS-resistant TRD patients (n=10) treated with TMS targeted to HCP MMP1.0 parcel 46. Moreover, both effective electroconvulsive therapy and effective TMS were associated with rsfc changes involving DLPFC parcel 46 and additional brain regions. This will be the first software to permit FDA-cleared functional targeting of TMS coil placement using functional as well as structural information, the first to permit virtual as well as on-line neuro-navigation and the first study to evaluate efficacy of surface-based parcel-guided TMS vs. standard of care. If successful, this project will permit improved, targeting of TMS target location across individuals, as well as implementation of personalized, MR-targeted TMS even within community treatment settings. 1

摘要 经颅磁刺激(TMS)是FDA批准的治疗难治性重度抑郁症的方法 (TRD)。然而，目前这种方法只有部分有效，部分原因是目标相对较低 接近了。近年来，越来越多的人意识到，TMS治疗快乐性厌食症 重度抑郁障碍(MDD)在左侧前额叶背外侧区域最有效 与亚膝前扣带回皮质负相关最大的皮层(L-DLPFC)AS 使用静息状态功能连接性磁共振成像(RsfcfMRI)确定。确定这一点的理想方法 然而，个别受试者的位置仍然取决于未经FDA批准的处理管道，因此 并且不能被TMS治疗社区访问。一般而言，可以分析3D大脑重建 使用传统的体积方法或最近开发的基于表面的方法 作为人类连接体项目(HCP)的一部分开发，并导致出版HCP多模式 脑图谱(HCP MMP1.0)。在体积方法中，基于结构和功能的方法具有两者 已经实施。在基于表面的HCP MMP1.0方法中，结构数据和功能数据被合并以 识别不同个体之间在功能上不连续的脑区。在这里，在第一阶段中，我们将首先开发一个 研究软件包(“TM Map”)，允许TMS研究人员利用体积或 基于曲面的基于MR的个性化L-DLPFC目标位置在线确定方法 并将创建一个并行的离线虚拟神经导航工具，以允许神经导航TMS即使在 无法使用在线神经导航功能的“社区”实践者。在第二阶段，我们将创建 符合图片存档和通信系统(PACS)的临床就绪版本，我们在 TMS耐药患者的多中心随机对照试验。我们将确保所有设备(软件 根据医疗标准制定)和数据(临床验证)要求在第二阶段结束前完成， 支持提交510(K)或从头提交具有积极临床结果的文件。该项目既建造了这两个建筑 由于Soterix Medical Inc.(SMI)对1)组合TMS和神经导航的使用长期感兴趣， 2)开发用于非侵入性脑刺激的自动靶向软件；从最近开始 哥伦比亚大学欧文医学中心(CUIMC)首席研究员的研究演示1) Hcp MMP1.0包46与sgACC在Hcp样本内的个体间的反相关性2)100% 针对HCP MMP1.0包46的TMS治疗耐TMS的TRD患者(n=10)的应答率。 此外，有效的电休克治疗和有效的TMS都与rsfc的变化有关。 牵涉到DLPFC 46号包裹和其他脑区。这将是第一个允许FDA批准的软件 使用功能和结构信息的TMS线圈放置的功能目标，第一个允许 虚拟神经导航和在线神经导航及评价地表性包裹导引效果的首次研究 TMS与标准护理的对比。如果成功，该项目将允许TMS目标位置的改进和定位 个人以及实施个性化的、以MR为目标的TMS，即使在社区治疗中也是如此 设置。 1