Parcel-guided rTMS for Major Depressive Disorder

NCT07287839 | Not Yet Recruiting Phase 2 FDA Device

• 1 other identifier: RTMSP2
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Treatment Resistant Depression (TRD)

Keywords

rTMS; TMS; parcel-guided; beam-F3

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

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

  Baseline and at Week 1

• Side-effect form (SEF)

  Daily from Baseline until Week 1

• Columbia suicide severity rating scale (C-SSRS)

  Baseline and Week 1

Study Arms (2)

Standard rTMS

ACTIVE COMPARATOR

rTMS using standard targeting (Beam-F3) will be delivered

Device: Accelerated rTMS

Parcel-guided rTMS

EXPERIMENTAL

rTMS will be delivered using brain-surface parcellation targeting

Device: Parcel-guided Accelerated rTMS

Interventions

Accelerated rTMS DEVICE

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.

Standard rTMS

Parcel-guided Accelerated rTMS DEVICE

rTMS targeting will be done using brain surface parcellation. Treatment will be delivered in an accelerated schedule with 50 treatment sessions over 5 days.

Parcel-guided rTMS

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
• 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

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; 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

Sponsors & Collaborators

• Columbia University Irving Medical Center, New York, NY: collaborator
• Soterix Medical: lead

Related Publications (1)

• 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.

  PMID: 32788580 BACKGROUND

MeSH Terms

Conditions

Depressive Disorder, Treatment-Resistant

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Abhishek Datta, PhD

  Soterix Medical, Inc.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yishai Valter, MS

CONTACT

888-990-8327; trials@soterixmedical.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2025
• First Posted: December 17, 2025
• Study Start: December 15, 2025
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 15, 2028
• Last Updated: December 18, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share