NCT07287839

Parcel-guided rTMS for Major Depressive Disorder

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

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Soterix Medical · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Treatment Resistant Depression (TRD)

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2025-12-15
• Primary completion: 2028-06-01
• Completion: 2028-06-15
• First posted: 2025-12-17
• Last updated: 2025-12-18

Regulatory

• FDA-regulated device study