Focused Ultrasound Neuromodulation in Patients With Treatment-Resistant Depression

NARecruitingINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

July 11, 2025

Primary Completion Date

August 31, 2027

Study Completion Date

August 31, 2027

Conditions
Treatment-Resistant DepressionTreatment-resistant Depression (TRD)
Interventions
DEVICE

Next Generation Dome Helmet (NGDH)

Participants will receive two sessions of Magnetic Resonance-guided focused ultrasound neuromodulation, spaced four weeks apart, using the Next Generation Dome Helmet device. Treatments will target regions within the CSTC circuit identified by advanced MRI scans. Each session will include pre-treatment assessments, precise sonications of deep brain structures, real-time safety monitoring, and post-treatment imaging.

Trial Locations (1)

M4N 3M5

RECRUITING

Sunnybrook Health Sciences Centre, Toronto

All Listed Sponsors
lead

Sunnybrook Health Sciences Centre

OTHER