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

Assessment of Safety and Feasibility of Focused Ultrasound (FUS) Next Generation Dome Helmet (NGDH) to Perform Neuromodulation in Patients With Substance Use Disorder (SUD)

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.

A total of 20 participants with treatment-resistant moderate-to-severe substance use disorder (SUD) will be enrolled and treated in this study. Participants will be enrolled from the local practices of the psychiatrists/addiction physicians involved in the study and through outside referrals, including physician referrals or self-referrals. Patient eligibility will be assessed at a screening appointment by the study coordinator and a physician associated with the study. The anticipated enrollment period is approximately two years.

Inclusion Criteria:

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

Exclusion Criteria:

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