Virtual Neuro-Navigation System for Personalized Community Based TMS

NCT04956081 | Completed DMC FDA Device

• 1 other identifier: SMICU061621
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

Phase I study of a virtual neuro-navigation package with built-in support for identifying specific "surface-based" targets to optimze TMS treatment.

Conditions

Treatment Resistant Depression

Outcome Measures

Primary Outcomes (1)

• Montgomery-Asberg Depression Rating Scale (MADRS)

  Depression severity scale where higher score indicates greater severity of symptoms

  2 times per week from Baseline until Week 6

Secondary Outcomes (4)

• Hamilton Depression Rating Scale Anxiety Somatization Subscale (HAMD-AS)33

  Baseline and at Week 6

• Side-effect form (SEF)

  2 times per week from Baseline until Week 6

• Columbia suicide severity rating scale (C-SSRS)

  2 times per week from Baseline until Week 6

• Concomitant Medication List (CML)

  2 times per week from Baseline until Week 6

Study Arms (2)

virtual neuro-navigation

EXPERIMENTAL

The specific area within the L-DLPFC will be identified by a software using MR images. TMS will be administered to the identified area.

Device: Neuro-navigated Transcranial Magnetic Stimulation (TMS)

on-line neuro-navigation

EXPERIMENTAL

The specific area within the L-DLPFC will be identified by a person using MR images. TMS will be administered to the identified area.

Device: Neuro-navigated Transcranial Magnetic Stimulation (TMS)

Interventions

Neuro-navigated Transcranial Magnetic Stimulation (TMS) DEVICE

TMS delivered to a target within the left- dorsolateral prefrontal cortex (L-DLPFC)

Also known as: Transcranial Magnetic Stimulation

on-line neuro-navigation; virtual neuro-navigation

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• DSM-5 diagnosis of major depressive disorder confirmed using the Mini International Neuropsychiatric Interview (MINI30) Axis 1 and mood modules
• Met criteria for treatment-resistant MDD during the current major depressive episode documented in the MGH Antidepressant Treatment History Questionnaire (ATRQ31), which will be defined as being non-responders (less than 50% of symptom improvement) to two or more depression treatment trials of adequate dose and duration as defined by the MGH ATRQ, as well as an adequate course of TMS treatment using standard targeting approaches (e.g. 5-cm, 5.5-cm, F3)
• at least moderate depression severity, operationalized as Montgomery-Asberg Depression Rating Scale (MADRS) score ≥ 20

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
• Currently pregnant or breastfeeding women; fecund women not using adequate contraceptive methods or with plan to become pregnant
• 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
• Actively suicidal, as defined by expressive ideation with a plan or with suicidal ideation that requires immediate medical or treatment intervention.
• A neurological or neuromuscular disorder
• Requires medications for a general medical condition that contraindicate the TMS treatment
• Prior non-response to ECT, vagal nerve stimulation (VNS) or deep brain stimulation (DBS)
• 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, l-methylfolate, s-adenosyl methionine, lithium) dosing must be stable for at least four weeks prior to study entry and patients must agree to continue at the same dose during the study

Sponsors & Collaborators

• Soterix Medical: lead
• Columbia University: collaborator

Study Sites (1)

Soterix Medical, Inc.

Woodbridge, New Jersey, 07095, 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: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Phase I open-label, 20 subjects

Study Record Dates

• First Submitted: June 16, 2021
• First Posted: July 9, 2021
• Study Start: July 1, 2021
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: September 29, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)