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Virtual neuro-navigation system for personalized,community-based TMSAward last edited on: 5/20/2023
Sponsored Program
SBIRAwarding Agency
NIH : NIMHTotal Award Amount
$964,357Award Phase
2Solicitation Topic Code
242Principal Investigator
Dennis Quangvinh TruongCompany Information
Soterix Medical Inc (AKA: SMI)
Aspen Corporate Park 1480 US Highway 9 North 204
Woodbridge, NJ 07095
Woodbridge, NJ 07095
(888) 990-8327 |
contact@soterixmedical.com |
www.soterixmedical.com |
Location: Single
Congr. District: 06
County: Middlesx
Congr. District: 06
County: Middlesx
Phase I
Contract Number: 1R44MH126833-01A1Start Date: 9/1/2021 Completed: 8/31/2023
Phase I year
2021Phase I Amount
$457,491Public Health Relevance Statement:
NARRATIVE Transcranial magnetic stimulation for the treatment of treatment resistant depression is partially effective (~40% response and ~35% remission), in part, due to ineffective targeting strategies. The standard "5-cm rule" approach dominates clinical practice but is known to miss the LDLPFC- the intended target. While on-line neuronavigation approaches that allow incorporating the patient's LDLPFC from individual MRI are being considered, adoption is slow. Furthermore, DLPFC is divided into 13 distinct parcels and regions. In a pilot study (n=10) of TMS-resistant TRD individuals, by targeting parcel 46 of LDLPFC, we were able to obtain 100% response and 50% remission. We aim to develop a software that will enable not only TMS groups that do not currently have navigation equipment but also groups that do have access to one. The software ("TMSMap") will provide scalp and brain coordinates corresponding to popular volumetric targeting approaches and our surface-based approach. The approaches will be clinically validated and all FDA device and regulatory requirements addressed. We aim to obtain either a 510(k) clearance or a de-novo approval immediately post Phase-2 pending favorable clinical outcome. 1
Project Terms:
Phase II
Contract Number: 5R44MH126833-02Start Date: 9/1/2021 Completed: 8/31/2023
Phase II year
2022(last award dollars: 2023)
Phase II Amount
$506,866Public Health Relevance Statement:
NARRATIVE Transcranial magnetic stimulation for the treatment of treatment resistant depression is partially effective (~40% response and ~35% remission), in part, due to ineffective targeting strategies. The standard "5-cm rule" approach dominates clinical practice but is known to miss the LDLPFC- the intended target. While on-line neuronavigation approaches that allow incorporating the patient's LDLPFC from individual MRI are being considered, adoption is slow. Furthermore, DLPFC is divided into 13 distinct parcels and regions. In a pilot study (n=10) of TMS-resistant TRD individuals, by targeting parcel 46 of LDLPFC, we were able to obtain 100% response and 50% remission. We aim to develop a software that will enable not only TMS groups that do not currently have navigation equipment but also groups that do have access to one. The software ("TMSMap") will provide scalp and brain coordinates corresponding to popular volumetric targeting approaches and our surface-based approach. The approaches will be clinically validated and all FDA device and regulatory requirements addressed. We aim to obtain either a 510(k) clearance or a de-novo approval immediately post Phase-2 pending favorable clinical outcome. 1
Project Terms: