Recruiting

FUS Neuromodulation

Sponsor:

Sunnybrook Health Sciences Centre

Code:

NCT07684976

Conditions

Substance Use Disorder (SUD)

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

Next Generation Dome Helmet (NGDH)

Study Details

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.

Conditions

Substance Use Disorder (SUD)

Study ID

NCT07684976

Start date

Jul, 2026

Status verified date

Jun, 2026

Completion date

Jul, 2028

Anticipated

Primary completion date

Jul, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Focused Ultrasound Neuromodulation - NAc First

Participants will undergo two focused ultrasound (FUS) neuromodulation sessions spaced four weeks apart. Treatments will target the nucleus accumbens and anterior insula. One of the two sessions may include sham exposure or active control sonication.

Interventions

Next Generation Dome Helmet (NGDH)

Focused ultrasound (FUS) neuromodulation delivered using the Next Generation Dome Helmet (NGDH) system under MRI guidance. The device delivers low-intensity pulsed ultrasound to targeted brain regions, including the nucleus accumbens and anterior insula, to modulate neural activity. Participants will undergo two treatment sessions spaced four weeks apart. One session may include sham exposure in which the device is positioned identically but no therapeutic ultrasound energy is delivered.

Primary outcome measure

  • Incidence and Severity of Adverse Events [ Time Frame: From baseline (prior to first treatment) through 4 weeks after the second treatment, including assessments on the day of each treatment, 1 day, 1 week, and 2 weeks after each treatment, and at 4 weeks after the second treatment. ]

Central Contacts and Locations

Central contacts

Nir Lipsman, MD, PhD, FRCSC

(416)-480-6954Nir.Lipsman@sunnybrook.ca

Anusha Baskaran, PhD

416-480-6100

Locations

Sunnybrook Health Sciences Centre

Recruiting

Toronto, Ontario, Canada, M4N 3M5

Contacts

Soraly Blanco

416-480-6100jaana.leppala@sunnybrook.ca

More Information

Sponsor

Sunnybrook Health Sciences Centre

Last update posted

Jul 6, 2026

Last verified

Jun, 2026

Keywords

  • Neuromodulation
  • Focused Ultrasound (FUS)
  • treatment-refractory substance use disorder

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Sunnybrook Health Sciences Centre on 2026-07-06.