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: 10775332
• 负责人: Dennis Quangvinh Truong
• 金额: $ 5.5万
• 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 2024-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10775332
• 关键词: 3-Dimensional; Address; Adoption; Anterior; Atlases; Brain; Brain region; Clinical; Communities; Computer software; Data; Development; Devices; Disease remission; Electroconvulsive Therapy; Ensure; Equipment; FDA approved; Favorable Clinical Outcome; Human; Individual; Interstitial Collagenase; Left; Location; Magnetic Resonance Imaging; Major Depressive Disorder; Medical; Neuronavigation; Outcome; Patients; Phase; Picture Archiving and Communication System; Pilot Projects; Prefrontal Cortex; Principal Investigator; Publications; Randomized, Controlled Trials; Research; Research Personnel; Resistance; Rest; Sampling; Scalp structure; Surface; Symptoms; System; Transcranial magnetic stimulation; Universities; Validation; cingulate cortex; clinic ready; clinical practice; connectome; efficacy evaluation; improved; interest; multimodality; noninvasive brain stimulation; reconstruction; response; 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 (“TMS-Targets”) 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 (CU) 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.

抽象的 经颅磁刺激 (TMS) 是一种 FDA 批准的治疗耐药性的治疗方法 然而，目前该方法仅部分有效，部分原因在于。 近年来，针对目标的方法相对无效。 认识到 TMS 对重度抑郁症 (MDD) 的快感缺乏样症状最有效 当针对左背外侧前额叶皮层 (L-DLPFC) 区域时有效，即 与膝下前扣带皮层 (sgACC) 最大反相关，如使用确定的 静息态功能连接 MRI (rsfcfMRI) 是识别该位置的理想方法。 然而，对于个别受试者，仍然依赖于未经 FDA 批准的加工管道 因此 TMS 治疗界无法访问 3D 大脑。 可以使用传统的体积方法或最近的方法来分析重建 开发基于表面的方法，作为人类连接组项目 (HCP) 的一部分 并导致 HCP 多模式脑图谱 (HCP MMP1.0) 的出版。 基于结构和功能的方法均已实施。 基于表面的HCP MMP1.0方法，结构和功能数据被合并以识别 在这里，在第一阶段，我们将首先开发一个跨个体的功能离散的大脑包。 研究软件包（“TMS-Targets”）将允许 TMS 研究人员利用 用于确定基于 MR 的个性化 L-的体积或基于表面的分析方法 DLPFC 在线定位目标，并将创建并行离线虚拟神经导航工具 即使对于无法访问在线神经网络的“社区”从业者，也允许使用神经导航 TMS 在第二阶段，我们将创建图片存档和通信功能。 符合系统 (PACS) 的临床就绪版本，我们在多中心随机中对其进行评估 在 TMS 抗性 TRD 个体中进行对照试验，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）要求已完成 II 期结束，以便能够进行 510(k) 或从头提交并获得积极的临床结果 该项目的建立源于 Soterix Medical Inc.(SMI) 的长期兴趣。 1) TMS 和神经导航的结合使用，2) 自动化的发展 用于非侵入性脑刺激的靶向软件；以及来自校长最近的研究 哥伦比亚大学 (CU) 的研究人员证明 1) HCP MMP1.0 包裹的反相关性 HCP 样本中的 46 个个体均具有 sgACC，并且 2) 100% 的响应率 TMS 耐药 TRD 患者 (n=10) 采用针对 HCP MMP1.0 46 号区的 TMS 治疗。 此外，有效的电休克治疗和有效的 TMS 均与 rsfc 相关。 涉及 DLPFC 包裹 46 和其他大脑区域的变化这将是第一个软件。 允许 FDA 批准的 TMS 线圈放置功能定位，使用功能性以及 结构信息，第一个允许虚拟和在线神经导航，也是第一个 研究评估基于表面的包裹引导 TMS 与标准护理的效果如果成功， 该项目将允许改进个人间 TMS 目标位置的定位，以及 即使在社区治疗环境中也能实施个性化、以 MR 为目标的 TMS。

项目成果

Optimized high-definition tDCS in patients with skull defects and skull plates.

优化颅骨缺损和颅骨板患者的高清 tDCS。

• 发表时间: 2023
• 作者: Guillen, Alexander;Truong, Dennis Q;Datta, Abhishek;Huang, Yu
• 通讯作者: Huang, Yu

Remotely supervised at-home delivery of taVNS for autism spectrum disorder: feasibility and initial efficacy.

远程监督在家递送 taVNS 治疗自闭症谱系障碍：可行性和初步疗效。

• 发表时间: 2023
• 作者: Black, Benjamin;Hunter, Samantha;Cottrell, Hannah;Dar, Roee;Takahashi, Nicole;Ferguson, Bradley J;Valter, Yishai;Porges, Eric;Datta, Abhishek;Beversdorf, David Q
• 通讯作者: Beversdorf, David Q

Visualizing interferential stimulation of human brains.

可视化人脑的干扰刺激。

• 发表时间: 2023
• 作者: Huang, Yu