Next-Generation Dome Helmet for Focused Ultrasound Neuromodulation in Treatment-Resistant Substance Use Disorder

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study evaluates the safety and feasibility of using MRI-guided focused ultrasound with a Next Generation Dome Helmet to modulate activity in the nucleus accumbens and/or anterior insula in adults with treatment-resistant substance use disorder. Twenty participants will undergo two FUS sessions about four weeks apart, with comprehensive baseline assessments and follow-up safety and clinical measures. The trial aims to determine whether the procedure can be delivered safely and whether there is a signal of reduced substance use severity at four weeks post-treatment, as measured by TLFB and related outcomes. Enrollment is planned over about two years at Sunnybrook Health Sciences Centre in Toronto. Imaging, quality-of-life, and safety data will be collected to characterize feasibility and potential clinical benefit.

Why it matters

Who can join: the full rules

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.

Where it's running

• Sunnybrook Health Sciences Centre
  Toronto, Ontario, Canada Recruiting

Study contacts

• Study coordinator: Nir Lipsman, MD, PhD, FRCSC
• Email: Nir.Lipsman@sunnybrook.ca
• Phone: (416)-480-6954

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.