Safety and Feasibility of Next-Generation Dome Helmet (NGDH) for Focused Ultrasound Neuromodulation in Substance Use Disorder (SUD)

Recruiting now · Not applicable · Has a placebo group

Conditions studied: Substance Use Disorder (SUD)

In brief

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.

Key facts

Study ID

NCT07684976

Run by

Sunnybrook Health Sciences Centre

People needed

20

Starts

2026-07-01

Expected to finish

2028-07-01

Last updated by the study team

2026-07-06

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Must be deemed to have capacity to provide informed consent (determined by the investigator)
• Age between 18 to 70 (inclusive)
• Diagnosis of SUD (cannabis, alcohol, ketamine, stimulant, opioid or nicotine/tobacco use disorder) in the moderate to severe range according to the DSM-5
• Previous ≥2 pharmacotherapy trials for the diagnosed SUD according to guideline-concordant, evidence-based care
• On a stable regimen of their psychiatric medications for 30 days before enrolment.

You may not qualify if…

• Pregnant or intending to be pregnant during the study
• Known active seizure disorder, significant head injury with an imaging verified lesion
• Medical illness that is deemed to be unstable or may confound the effects of the intervention
• Not eligible for 3-Tesla MRI (i.e. MRI-incompatible pacemaker)
• Unable to reliably attend the required screening, treatment, and follow up appointments.
• Severe claustrophobia, identified by the subject to be a limiting factor preventing MRI.
• Scores 18 or below on Montreal Cognitive Assessment (MoCA)
• Weighs 250 lbs or more.

Where it is running

• Sunnybrook Health Sciences Centre — Toronto, Ontario, Canada (enrolling)

Full record on ClinicalTrials.gov

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