NCT07094789

Focused Ultrasound Neuromodulation in Patients With Treatment-Resistant Depression

Assessment of Safety and Feasibility of Focused Ultrasound Next Generation Dome Helmet (NGDH) to Perform Neuromodulation in Patients With Treatment-Resistant Depression

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Sunnybrook Health Sciences Centre · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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 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.

Detailed description

A total of 20 participants with treatment-resistant depression will be enrolled and treated in this study. Participants will be recruited through local psychiatric practices, referrals from participating institutions, and external referrals, including both physician and self-referrals. Eligibility will be assessed during a dedicated screening appointment conducted by the study coordinator in collaboration with a study-affiliated physician. The anticipated enrollment period is approximately two years, beginning from the date of first patient enrollment to the enrollment of the final participant.

Conditions

• Treatment-Resistant Depression
• Treatment-resistant Depression (TRD)

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-07-11
• Primary completion: 2027-08-01
• Completion: 2027-08-01
• First posted: 2025-07-30
• Last updated: 2025-08-11

Locations

1 site across 1 country: Canada