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.
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
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)
Single group
Next Generation Dome Helmet (NGDH)
DeviceFocused 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.
Incidence and Severity of Adverse Events
Safety will be evaluated by assessing the incidence, severity, and relationship of adverse events associated with FUS neuromodulation.
Change in Number of Drinking Days Using the Timeline Followback (TLFB)
The Timeline Followback (TLFB) is a validated calendar-based self-report method used to assess daily alcohol consumption over a defined period. Participants will report the number of standard drinks consumed each day over the previous 30 days. The total number of days on which alcohol was consumed will be calculated.
Change in Average Number of Drinks per Drinking Day Using TLFB
Participants' daily alcohol consumption over the previous 30 days will be assessed using the TLFB. The average number of standard drinks per drinking day will be calculated.
Change in Percent Days Abstinent Using TLFB
Using TLFB data, the percentage of days during the assessment period on which no alcohol was consumed will be calculated.
Change in Number of Heavy Drinking Days Using TLFB
Heavy drinking days will be defined as ≥5 drinks per day for men and ≥4 drinks per day for women. The number of such days over the assessment period will be calculated using TLFB data.
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