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

> **NIH NIH R44** · SOTERIX MEDICAL,INC. · 2022 · $451,866

## Abstract

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...

## Key facts

- **NIH application ID:** 10474577
- **Project number:** 5R44MH126833-02
- **Recipient organization:** SOTERIX MEDICAL,INC.
- **Principal Investigator:** Dennis Quangvinh Truong
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $451,866
- **Award type:** 5
- **Project period:** 2021-09-01 → 2024-11-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10474577

## Citation

> US National Institutes of Health, RePORTER application 10474577, Virtual neuro-navigation system for personalized,community-based TMS (5R44MH126833-02). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10474577. Licensed CC0.

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