Condition: Treatment-Resistant Depression · Treatment-resistant Depression (TRD) · Sponsor: Sunnybrook Health Sciences Centre
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.
This description comes directly from the study's public registry record.
Nir Lipsman, MD, PhD, FRCSC · (416)-480-6954 · Nir.Lipsman@sunnybrook.ca
Anusha Baskaran, PhD · 416-480-6100 · anusha.baskaran@sunnybrook.ca
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| Sunnybrook Health Sciences Centre | Toronto, Ontario, Canada | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07094789