NCT07684976 Safety and Feasibility of Next-Generation Dome Helmet (NGDH) for Focused Ultrasound Neuromodulation in Substance Use Disorder (SUD)
| NCT ID | NCT07684976 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Sunnybrook Health Sciences Centre |
| Condition | Substance Use Disorder (SUD) |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2026-07 |
| Primary Completion | 2028-07 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 20 participants in total. It began in 2026-07 with a primary completion date of 2028-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07684976 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Substance Use Disorder (SUD). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07684976 currently recruiting?
Yes, NCT07684976 is actively recruiting participants. Contact the research team at Nir.Lipsman@sunnybrook.ca for enrollment information.
Where is the NCT07684976 trial being conducted?
This trial is being conducted at Toronto, Canada.
Who is sponsoring the NCT07684976 clinical trial?
NCT07684976 is sponsored by Sunnybrook Health Sciences Centre. The trial plans to enroll 20 participants.