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Safety and Feasibility of Next-Generation Dome Helmet (NGDH) for Focused Ultrasound Neuromodulation in Substance Use Disorder (SUD)
Sponsor: Sunnybrook Health Sciences Centre
Summary
The goal of this clinical trial is to evaluate the safety, feasibility, and preliminary clinical benefit of focused ultrasound (FUS) neuromodulation using the FUS Next Generation Dome Helmet (NGDH) in adults with treatment-resistant moderate-to-severe substance use disorder (SUD). The main questions it aims to answer are: Can FUS neuromodulation be safely delivered to the nucleus accumbens (NAc) and/or anterior insula (aI)? Does FUS neuromodulation result in reduced substance use severity, as measured by Timeline Followback (TLFB), by 4 weeks post-treatment? Participants will: Complete baseline clinical assessments, questionnaires, imaging, and safety assessments. Undergo two MRI-guided FUS neuromodulation sessions approximately 4 weeks apart. Attend follow-up visits for safety monitoring, symptom assessments, quality-of-life measures, and additional imaging where applicable.
Official title: Assessment of Safety and Feasibility of Focused Ultrasound (FUS) Next Generation Dome Helmet (NGDH) to Perform Neuromodulation in Patients With Substance Use Disorder (SUD)
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
20
Start Date
2026-07
Completion Date
2028-07
Last Updated
2026-07-06
Healthy Volunteers
No
Conditions
Interventions
Next Generation Dome Helmet (NGDH)
Focused ultrasound (FUS) neuromodulation delivered using the Next Generation Dome Helmet (NGDH) system under MRI guidance. The device delivers low-intensity pulsed ultrasound to targeted brain regions, including the nucleus accumbens and anterior insula, to modulate neural activity. Participants will undergo two treatment sessions spaced four weeks apart. One session may include sham exposure in which the device is positioned identically but no therapeutic ultrasound energy is delivered.
Locations (1)
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada