Development of Neuro-Navigated Transcranial Magnetic Stimulation (TMS) Using MRI

NCT05598931 | Completed DMC FDA Device

• 1 other identifier: SMICU061621B
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Healthy controls (HC) will be studied once to provide data needed to validate the virtual neuro-navigation system. All subjects will undergo a single MRI session and will then participate in an on-line neuro-navigation session in which various TMS coil positions will be recorded. The brain/head images will be provided to the programmer to permit development of the virtual neuro-navigation algorithm. Data from Yr1 will be used by the programmer as a training sample, and from Yr2 as a test sample.

Conditions

Treatment Resistant Depression

Outcome Measures

Primary Outcomes (1)

• Brain Coordinates

  MRI based brain coordinates will be determined using newly developed neuronavigation software

  Day 1

Study Arms (1)

Healthy Controls

Subjects will undergo a single MRI session and will then participate in an on-line neuro-navigation session in which various TMS coil positions will be recorded. The brain/head images will be provided to the programmer to permit development of the virtual neuro-navigation algorithm. Data from Yr1 will be used by the programmer as a training sample, and from Yr2 as a test sample.

Device: Transcranial Magnetic Stimulation

Interventions

Transcranial Magnetic Stimulation DEVICE

Subjects will participate in an on-line neuro-navigation session in which 6 TMS coil positions will be recorded.

Healthy Controls

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Healthy Controls

You may qualify if:

• Non-depressed subjects

You may not qualify if:

• Ever met criteria for a psychotic disorder (Sz, SzAff, Bipolar disorder); anorexia nervosa or bulimia nervosa within the last year
• Unstable medical condition by history, physical exam or laboratory results
• Contraindications to MRI (based on metal screening form)
• Meets criteria for claustrophobia
• Recent drug or alcohol use disorder with DSM-5 specifier of moderate or severe within 6 months, or mild within 2 months; lifetime history of IV drug use
• A neurological or neuromuscular disorder;
• Require medications for a general medical condition that contraindicate the TMS treatment
• History of ketamine treatment within 6 mo
• History of monoamine oxidase inhibitor (MAOI) within the past month
• Lacks capacity to consent
• Taking medications that increase the risk of seizures. For patients on permitted concomitant psychotropic agents (antidepressants, anticonvulsants, benzodiazepines, hypnotics, opiates, triiodothyronine (T3), modafinil, psychostimulants, buspirone, melatonin, omega-3 fatty acids, folate, lmethylfolate, s-adenosyl methionine, lithium) dosing must be stable for at least four weeks prior to study entry

Sponsors & Collaborators

• Soterix Medical: lead
• Columbia University: collaborator

Study Sites (1)

Columbia University Irving Medical Center

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Treatment-Resistant

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2021
• First Posted: October 28, 2022
• Study Start: July 1, 2021
• Primary Completion: October 1, 2024
• Study Completion: October 1, 2024
• Last Updated: September 29, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)