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

NCT07684976 | Recruiting

• 1 other identifier: 6703
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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)

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Incidence and Severity of Adverse Events

  Safety will be evaluated by assessing the incidence, severity, and relationship of adverse events associated with FUS neuromodulation.

  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.

Secondary Outcomes (11)

• Change in Number of Drinking Days Using the Timeline Followback (TLFB)

  Baseline, 2 weeks after the first treatment, and 2 and 4 weeks after the second treatment

• Change in Average Number of Drinks per Drinking Day Using TLFB

  Baseline, 2 weeks after the first treatment, and 2 and 4 weeks after the second treatment

• Change in Percent Days Abstinent Using TLFB

  Baseline, 2 weeks after the first treatment, and 2 and 4 weeks after the second treatment

• Change in Number of Heavy Drinking Days Using TLFB

  Baseline, 2 weeks after the first treatment, and 2 and 4 weeks after the second treatment

• Subjective Ratings of Mood, Anxiety, Energy, and Optimism Using 1-9 Likert Scales

  Baseline, immediately before and after each treatment, 24 hours after each treatment, and 2 and 4 weeks after the second treatment

Study Arms (1)

Focused Ultrasound Neuromodulation - NAc First

EXPERIMENTAL

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.

Device: Next Generation Dome Helmet (NGDH)

Interventions

Next Generation Dome Helmet (NGDH) DEVICE

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.

Focused Ultrasound Neuromodulation - NAc First

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 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.

You may not qualify 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.
• Scores 18 or below on Montreal Cognitive Assessment (MoCA)
• Weighs 250 lbs or more.

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead

Study Sites (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

RECRUITING

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Central Study Contacts

Nir Lipsman, MD, PhD, FRCSC

CONTACT

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

Anusha Baskaran, PhD

CONTACT

416-480-6100

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator MD, PHD, FRCSC, FAANS

Study Record Dates

• First Submitted: August 8, 2025
• First Posted: July 6, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2028
• Last Updated: July 6, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)