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Tests treatment safety and results for Substance Use Disorder (SUD)
Official title Safety and Feasibility of Next-Generation Dome Helmet (NGDH) for Focused Ultrasound Neuromodulation in Substance Use Disorder (SUD)
ClinicalTrials.gov ID: NCT07684976
What this study is testing
- What it's testing
- 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)?
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- 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...
- 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.
You likely can't join if
- 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.
See the full eligibility criteria
- 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Toronto, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Toronto, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.