Who is eligible for clinical trial NCT07684976?

Participants must meet protocol criteria for Substance Use Disorder (SUD). Confirm exact inclusion and exclusion requirements with the study coordinator.

Does clinical trial NCT07684976 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2026-07-02

Safety and Feasibility of Next-Generation Dome Helmet (NGDH) for Focused Ultrasound Neuromodulation in Substance Use Disorder (SUD) (NCT07684976)

🟢 Recruiting Observational / Diagnostic ⚙️ Medical Device Protocol Sponsor: Sunnybrook Health Sciences Centre

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (5 items) and avoid the listed exclusions (9 items).

Location: Sunnybrook Health Sciences Centre — Toronto, Ontario

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

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.

Usually NOT eligible if any of the following apply:

Exclusion Criteria:
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.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

Sunnybrook Health Sciences Centre — Toronto, Ontario

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

🏛️ View Official NIH Record ↗