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Depression Neuromodulation trials

Focused Ultrasound Neuromodulation in Patients With Treatment-Resistant Depression

RecruitingNCT07094789Phase: NAStarted 2025-07-11

Summary

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

Eligibility

Sex
ALL
Min Age
18 Years
Max Age
65 Years

Inclusion Criteria: 1. Deemed to have the capacity to provide informed consent. 2. Aged between 18 and 65 years. 3. Diagnosis of major depressive disorder (MDD) according to DSM-5 criteria. 4. Total score \>20 on the Hamilton Depression Rating Scale (HAMD-17). 5. On a stable regimen of psychiatric

Locations

Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada

Interested in participating? View the full study details on ClinicalTrials.gov:

View on ClinicalTrials.gov →