Focused Ultrasound Neuromodulation in Patients With Treatment-Resistant Depression

The goal of this clinical trial is to evaluate the safety and initial effectiveness of Magnetic Resonance-guided focused ultrasound neuromodulation using the Next Generation Dome Helmet (NGDH) device in patients with treatment-resistant depression. This is a prospective, single-arm, non-randomized study. Participants will: * Undergo two focused ultrasound treatment sessions targeting nodes of the cortical-striatal-thalamic circuit (CSTC) , spaced four weeks apart. * Return for follow-up visits at 24 hours, 2 weeks, and 4 weeks after each treatment session, during which clinical scales and imaging assessments will be conducted to monitor safety and clinical effects.

NCT Number	NCT07094789
Lead Sponsor	Sunnybrook Health Sciences Centre
Conditions	Treatment-Resistant Depression, Treatment-resistant Depression (TRD)
Enrollment	20 participants
Start Date	2025-07-11
Primary Completion	2027-08 (estimated)
Study Completion	2027-08 (estimated)
Updated on ClinicalTrials.gov	2025-08-11