Virtual Neuro-Navigation System for Personalized Community Based TMS

Completed · Not applicable

Conditions studied: Treatment Resistant Depression

In brief

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

Key facts

Study ID

NCT04956081

Run by

Soterix Medical

People needed

22

Starts

2021-07-01

Expected to finish

2025-09-01

Last updated by the study team

2025-09-29

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• Soterix Medical, Inc. — Woodbridge, New Jersey, United States

Full record on ClinicalTrials.gov

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