Parcel-guided rTMS for Major Depressive Disorder

Phase-2 Trial of Parcel-guided rTMS for Major Depressive Disorder

Study comparing standard repetitive transcranial magnetic stimulation (rTMS) for Depression to a novel targeting approach using brain surface parcellation to locate a specific brain target.

Study Overview

• Status: Not yet recruiting
• Conditions: Treatment Resistant Depression (TRD)
• Intervention / Treatment: Device: Accelerated rTMS; Device: Parcel-guided Accelerated rTMS

Detailed Description

Standard rTMS treatment often uses the "Beam-F3" targeting approach to locate a brain region known as the left dorsolateral prefrontal cortex (lDLPFC). However, Beam-F3 does not take into account interindividual variation in brain anatomy. Researchers as Columbia University have found a more accurate and personalized approach that uses MRI-based brain surface parcellation to locate the specific subregion of the lDLPFC most ideal for rTMS treatment. Our study is comparing standard rTMS (Beam-F3) to parcel-guided rTMS for patients with treatment resistant depression.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Yishai Valter, MS; Phone Number: 888-990-8327; Email: trials@soterixmedical.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• DSM-5 diagnosis of major depressive disorder confirmed using the Mini International Neuropsychiatric Interview (MINI30) Axis 1 and mood modules
• 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.
• At least moderate depression severity, operationalized as Montgomery-Asberg Depression Rating Scale (MADRS) score ≥ 20

Exclusion Criteria:

• 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; or lifetime history of IV drug use A- ctively suicidal, as defined by expressive ideation with a plan or with suicidal ideation that requires immediate medical or treatment intervention.
• 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 months
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard rTMS; rTMS using standard targeting (Beam-F3) will be delivered	Device: Accelerated rTMS; rTMS targeting will be done using the standard Beam-F3 targeting method. Treatment will be delivered in an accelerated schedule with 50 treatment session over 5 days.
Experimental: Parcel-guided rTMS; rTMS will be delivered using brain-surface parcellation targeting	Device: Parcel-guided Accelerated rTMS; rTMS targeting will be done using brain surface parcellation. Treatment will be delivered in an accelerated schedule with 50 treatment sessions over 5 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Montgomery-Asberg Depression Rating Scale (MADRS)	Depression severity scale with a score ranging from 0 to 60 where a higher score indicates greater severity of symptoms.	Baseline and at end of Week 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Side-effect form (SEF)	Clinician-rated simple form to document the onset, course, severity, and causality of adverse events	Daily from Baseline until Week 1
Hamilton Depression Rating Scale Anxiety Somatization Subscale (HAMD-AS)	six-item subscale of psychiatric disorder severity where a score is given between 0 and 18 and a higher score indicates greater severity of symptoms	Baseline and at Week 1
Columbia suicide severity rating scale (C-SSRS)	Rating scale for suicidal ideation with scores ranging from 0 to 5 where a higher score indicates greater severity of symptoms	Baseline and Week 1

Collaborators and Investigators

• Sponsor: Soterix Medical
• Collaborators: Columbia University Irving Medical Center, New York, NY
• Investigators: Principal Investigator: Abhishek Datta, PhD, Soterix Medical, Inc.

Publications and helpful links

General Publications

• Moreno-Ortega M, Kangarlu A, Lee S, Perera T, Kangarlu J, Palomo T, Glasser MF, Javitt DC. Parcel-guided rTMS for depression. Transl Psychiatry. 2020 Aug 12;10(1):283. doi: 10.1038/s41398-020-00970-8.

Study record dates

Study Major Dates

• Study Start (Estimated): December 15, 2025
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 15, 2028

Study Registration Dates

• First Submitted: December 13, 2025
• First Submitted That Met QC Criteria: December 13, 2025
• First Posted (Estimated): December 17, 2025

Study Record Updates

• Last Update Posted (Actual): December 18, 2025
• Last Update Submitted That Met QC Criteria: December 17, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: rTMS; TMS; parcel-guided; beam-F3
• Additional Relevant MeSH Terms: Mental Disorders; Mood Disorders; Depressive Disorder; Depressive Disorder, Treatment-Resistant
• Other Study ID Numbers: RTMSP2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No