Substance Use Disorder (SUD)NCT07684976
Safety and Feasibility of Next-Generation Dome Helmet (NGDH) for Focused Ultrasound Neuromodulation in Substance Use Disorder (SUD)
A study testing Next Generation Dome Helmet (NGDH) in people with Substance Use Disorder (SUD), run by Sunnybrook Health Sciences Centre at 1 site in Canada.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Substance Use Disorder (SUD)
- What is being tested?
- Next Generation Dome Helmet (NGDH)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2026to Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Anusha Baskaran, PhD contact
Canada1 site, 1 recruiting
- Recruiting
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5
Soraly Blanco, 416-480-6100 ext. 61519, jaana.leppala@sunnybrook.ca
About this study
Official title: Assessment of Safety and Feasibility of Focused Ultrasound (FUS) Next Generation Dome Helmet (NGDH) to Perform Neuromodulation in Patients With Substance Use Disorder (SUD)
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:
Read more
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.
Read the detailed description
A total of 20 participants with treatment-resistant moderate-to-severe substance use disorder (SUD) will be enrolled and treated in this study. Participants will be enrolled from the local practices of the psychiatrists/addiction physicians involved in the study and through outside referrals, including physician referrals or self-referrals. Patient eligibility will be assessed at a screening appointment by the study coordinator and a physician associated with the study. The anticipated enrollment period is approximately two years.
- Conditions
- Substance Use Disorder (SUD)
- Being tested
- Next Generation Dome Helmet (NGDH)
- Keywords
- Neuromodulation, Focused Ultrasound (FUS), treatment-refractory substance use disorder
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Next Generation Dome Helmet (NGDH) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and Severity of Adverse Events
Safety will be evaluated by assessing the incidence, severity, and relationship of adverse events associated with FUS neuromodulation.
Measured: 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)
The Timeline Followback (TLFB) is a validated calendar-based self-report method used to assess daily alcohol consumption over a defined period. Participants will report the number of standard drinks consumed each day over the previous 30 days. The total number of days on which alcohol was consumed will be calculated.
Measured: 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
Participants' daily alcohol consumption over the previous 30 days will be assessed using the TLFB. The average number of standard drinks per drinking day will be calculated.
Measured: Baseline, 2 weeks after the first treatment, and 2 and 4 weeks after the second treatment
Change in Percent Days Abstinent Using TLFB
Using TLFB data, the percentage of days during the assessment period on which no alcohol was consumed will be calculated.
Measured: 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
Heavy drinking days will be defined as ≥5 drinks per day for men and ≥4 drinks per day for women. The number of such days over the assessment period will be calculated using TLFB data.
Measured: 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
Participants will complete a brief set of self-reported Likert scales rating their current mood, anxiety, energy level, and optimism for the future. Each item is scored on a 1 to 9 scale, where:
1 = very low/poor 9 = very high/excellent These scales are used to capture rapid, subjective changes in well-being and affective state across the course of treatment.
Measured: Baseline, immediately before and after each treatment, 24 hours after each treatment, and 2 and 4 weeks after the second treatment
Change in Depressive Symptoms Using the Hamilton Depression Rating Scale (HAMD-17)
The HAMD-17 is a clinician-administered scale with 17 items measuring the severity of depressive symptoms. Total scores range from 0 to 52, with higher scores indicating more severe depression.
Measured: Baseline, 2 weeks after the first treatment, and 2 and 4 weeks after the second treatment
Change in anxiety symptoms using the Beck Anxiety Inventory (BAI)
Anxiety symptoms will be assessed using the Beck Anxiety Inventory (BAI), a 21-item self-report questionnaire. Each item is scored from 0 to 3, with a total score range of 0 to 63. Higher scores indicate greater anxiety symptom severity. Scores will be compared from baseline to post-treatment follow-up assessments.
Measured: Baseline, 2 weeks after the first treatment, and 2 and 4 weeks after the second treatment
Change in drug use severity using the Drug Use Disorders Identification Test (DUDIT)
Drug use severity will be assessed using the Drug Use Disorders Identification Test (DUDIT) in participants with drug-related substance use disorder, including stimulant, opioid, and/or ketamine use disorder. The DUDIT is an 11-item instrument used to assess drug-related problems. Items 1-9 are scored from 0 to 4, and items 10-11 are scored as 0, 2, or 4. The total score ranges from 0 to 44, with higher scores indicating greater drug use severity or greater likelihood of drug-related problems. Scores will be compared from baseline to post-treatment follow-up assessments.
Measured: Baseline, 3 months after the second treatment, and 6 months after the second treatment
Barratt Impulsiveness Scale (BIS-11)
The Barratt Impulsiveness Scale (BIS-11) is a widely utilized 30-item self-report instrument for assessing impulsivity. It is designed for the assessment of impulsivity in both research and clinical settings.
Measured: Baseline, 2 weeks after the first treatment, and 2 and 4 weeks after the second treatment
DSM-5 substance use disorders symptom checklist
11-item checklist based on behaviors over the past 12 months, classified as mild (2-3 symptoms), moderate (4-5), or severe (6+). Key symptoms include failed attempts to cut down, using more than intended, cravings, neglecting obligations, and continued use despite problems.
Measured: Baseline, 2 weeks after the first treatment, and 2 and 4 weeks after the second treatment.
The Colorado Symptom Index (CSI)
14-item, self-report questionnaire designed to measure the frequency of psychiatric symptoms (e.g., depression, anxity, psychosis) over the past month.
Measured: Baseline, 2 weeks after the first treatment, and 2 and 4 weeks after the second treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2026
- Study startJul 2026 (estimated)
- Primary completionJul 2028 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance Use Disorder (SUD)Studies of the same condition, open and under way.
- More trials run by Sunnybrook Health Sciences CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Nir Lipsman, Sunnybrook Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07684976
- Sponsor's protocol ID
- 6703
- Status last verified
- Jun 2026
- First submitted
- 8 Aug 2025
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Safety and Feasibility of Focused Ultrasound (FUS) Next Generation Dome Helmet (NGDH) to Perform Neuromodulation in Patients With Substance Use Disorder (SUD)
- ClinicalTrials.gov ID
- NCT07684976
- Acronym / sponsor ID
- 6703
- Conditions
- Substance Use Disorder (SUD)
- Keywords
- Neuromodulation, Focused Ultrasound (FUS), treatment-refractory substance use disorder
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Study start
- Jul 2026 (estimated)
- Primary completion
- Jul 2028 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 6 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
A total of 20 participants with treatment-resistant moderate-to-severe substance use disorder (SUD) will be enrolled and treated in this study. Participants will be enrolled from the local practices of the psychiatrists/addiction physicians involved in the study and through outside referrals, including physician referrals or self-referrals. Patient eligibility will be assessed at a screening appointment by the study coordinator and a physician associated with the study. The anticipated enrollment period is approximately two years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Focused Ultrasound Neuromodulation - NAc First | Experimental | Device: Next Generation Dome Helmet (NGDH)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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Focused Ultrasound Neuromodulation - NAc First |
Primary outcome
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.
Safety will be evaluated by assessing the incidence, severity, and relationship of adverse events associated with FUS neuromodulation.
11 secondary outcomes
Change in Number of Drinking Days Using the Timeline Followback (TLFB)
Time frame: 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
Time frame: Baseline, 2 weeks after the first treatment, and 2 and 4 weeks after the second treatment
Change in Percent Days Abstinent Using TLFB
Time frame: 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
Time frame: 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
Time frame: Baseline, immediately before and after each treatment, 24 hours after each treatment, and 2 and 4 weeks after the second treatment
Change in Depressive Symptoms Using the Hamilton Depression Rating Scale (HAMD-17)
Time frame: Baseline, 2 weeks after the first treatment, and 2 and 4 weeks after the second treatment
Change in anxiety symptoms using the Beck Anxiety Inventory (BAI)
Time frame: Baseline, 2 weeks after the first treatment, and 2 and 4 weeks after the second treatment
Change in drug use severity using the Drug Use Disorders Identification Test (DUDIT)
Time frame: Baseline, 3 months after the second treatment, and 6 months after the second treatment
Barratt Impulsiveness Scale (BIS-11)
Time frame: Baseline, 2 weeks after the first treatment, and 2 and 4 weeks after the second treatment
DSM-5 substance use disorders symptom checklist
Time frame: Baseline, 2 weeks after the first treatment, and 2 and 4 weeks after the second treatment.
The Colorado Symptom Index (CSI)
Time frame: Baseline, 2 weeks after the first treatment, and 2 and 4 weeks after the second treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Anusha Baskaran, PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Next Generation Dome Helmet (NGDH) in people with Substance Use Disorder (SUD), run by Sunnybrook Health Sciences Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nir Lipsman, MD, PhD, FRCSC ((416)-480-6954, Nir.Lipsman@sunnybrook.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2026.