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

基本信息

批准号：
10474577
负责人：
Dennis Quangvinh Truong
金额：
$ 45.19万
依托单位：
SOTERIX MEDICAL,INC.
依托单位国家：
美国
项目类别：
财政年份：
2021
资助国家：
美国
起止时间：
2021-09-01 至 2024-08-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10474577
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 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

项目摘要

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

抽象的经颅磁刺激 (TMS) 是 FDA 批准的一种治疗难治性重度抑郁症的疗法 (TRD) 然而，目前该方法仅部分有效，部分原因是目标相对无效。近年来，人们越来越认识到 TMS 可以治疗快感缺失样症状。当针对左背外侧前额叶区域时，重度抑郁症 (MDD) 最有效与膝下前扣带皮层 (sgACC) 最大反相关的皮质 (L-DLPFC) 使用静息态功能连接 MRI (rsfcfMRI) 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 批准的加工管道，因此并且 TMS 治疗界无法访问。一般来说，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组项目 (HCP) 的一部分而开发，并导致 HCP 多模式的出版脑图谱（HCP MMP1.0）在体积方法中，基于结构和功能的方法两者都有。在基于表面的 HCP MMP1.0 方法中，结构和功能数据被合并到。在这里，在第一阶段，我们将首先开发一个功能独立的大脑区域。研究软件包（“TMSMap”）将允许 TMS 研究人员利用体积或基于表面的分析方法，用于在线确定基于 MR 的个性化 L-DLPFC 目标位置，并将创建一个并行离线虚拟神经导航工具，以允许神经导航 TMS，甚至在第二阶段，我们将创建无法访问在线神经导航功能的“社区”从业者。符合图片存档和通信系统 (PACS) 要求的临床就绪版本，我们在在 TMS 耐药 TRD 个体中进行多中心随机对照试验，我们将确保所有设备（软件）。根据医疗标准开发）和数据（临床验证）要求在第二阶段结束时完成，以能够追求 510(k) 或从头提交并取得积极的临床成果。源自 Soterix Medical Inc.(SMI) 对 1) 结合 TMS 和神经导航的使用的长期兴趣， 2）最近开发了用于非侵入性脑刺激的自动瞄准软件；哥伦比亚大学欧文医学中心 (CUIMC) 首席研究员的研究表明 1) HCP MMP1.0 地块 46 与 HCP 样本内各个个体的 sgACC 反相关，2) 100% TMS 耐药 TRD 患者 (n=10) 接受针对 HCP MMP1.0 包裹 46 的 TMS 治疗的缓解率。此外，有效的电休克治疗和有效的 TMS 均与 rsfc 变化相关 DLPFC 包裹 46 和其他大脑区域这将是第一个允许涉及 FDA 批准的软件。使用功能和结构信息对 TMS 线圈放置进行功能定位，这是第一个允许虚拟和在线神经导航以及第一项评估基于表面的包裹引导效果的研究 TMS 与护理标准如果成功，该项目将允许改进 TMS 目标位置的定位。个人，以及甚至在社区治疗中实施个性化、以 MR 为目标的 TMS 设置。 1