Focused Ultrasound Neuromodulation for Depression

Overseen By Anusha Baskaran, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Sunnybrook Health Sciences Centre

Must be taking: Psychiatric medications

Disqualifiers: Pregnancy, Substance use disorder, Seizure, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 9

Duration: 8 weeks

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment option for individuals with depression that has not improved after standard treatments. It involves two sessions of focused ultrasound, a technique using sound waves to reach deep brain areas, to determine if it can safely improve symptoms. The treatment will be administered using the Next Generation Dome Helmet (NGDH). Participants will undergo follow-up checks to monitor progress. Suitable candidates for this trial include those diagnosed with major depressive disorder who have been on stable medication and have tried two antidepressants and therapy without success. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research in depression treatment.

Do I need to stop my current medications for the trial?

The trial requires that you have been on a stable regimen of psychiatric medications for at least 30 days before joining, so you will not need to stop your current medications.

What prior data suggests that the Next Generation Dome Helmet (NGDH) device is safe for treating depression?

Research shows that focused ultrasound treatment is usually well-tolerated by patients. In earlier studies, patients experienced improved mood and reduced anxiety without major side effects. Some reported mild discomfort, but serious problems were rare. This suggests the treatment might be safe for those with depression that hasn't improved with other treatments. However, as with any medical procedure, individual experiences can vary. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Next Generation Dome Helmet (NGDH) for depression because it offers a non-invasive, focused ultrasound neuromodulation approach. Unlike traditional treatments like antidepressants or electroconvulsive therapy, this method targets specific regions in the brain's cortical-striatal-thalamic circuit, which are linked to treatment-resistant depression. This precision could lead to fewer side effects and potentially faster improvements in symptoms, making it a promising alternative for those who haven't responded well to existing therapies.

What evidence suggests that the Next Generation Dome Helmet is effective for treatment-resistant depression?

Research shows that focused ultrasound neuromodulation might help people with depression unresponsive to other treatments. This method targets specific brain areas related to mood disorders. Early studies have shown it may improve mood and reduce anxiety. The treatment uses sound waves to alter brain activity without surgery. Although more research is needed, these early findings suggest it could be a promising option for those who haven't found success with other treatments. Participants in this trial will receive two sessions of Magnetic Resonance-guided focused ultrasound neuromodulation targeting regions within the cortical-striatal-thalamic circuit (CSTC) implicated in treatment-resistant depression. ^{1 2 3 4 5}

Are You a Good Fit for This Trial?

This trial is for individuals with treatment-resistant depression, meaning they haven't responded well to standard treatments. Participants will undergo two ultrasound sessions targeting brain areas linked to depression and attend follow-up visits for safety and effectiveness monitoring.

Inclusion Criteria

I am between 18 and 65 years old.

Total score >20 on the Hamilton Depression Rating Scale (HAMD-17)

Documented previous trial of at least two first-line antidepressant agents at adequate dose and duration, as assessed by two psychiatrists

Exclusion Criteria

Diagnosis of a substance use disorder (excluding cannabis or nicotine) of moderate severity or greater, or when the substance is the primary focus of treatment, based on DSM-5 criteria

Unstable medical illness

I have an active seizure disorder or a significant head injury with a confirmed lesion.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants undergo two focused ultrasound treatment sessions targeting nodes of the cortical-striatal-thalamic circuit, spaced four weeks apart

8 weeks

2 visits (in-person)

Follow-up

Participants return for follow-up visits at 24 hours, 2 weeks, and 4 weeks after each treatment session to monitor safety and clinical effects

8 weeks

6 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Next Generation Dome Helmet (NGDH)

Trial Overview The study tests the Next Generation Dome Helmet (NGDH) device's ability to safely modulate specific brain circuits using focused ultrasound in patients who have not found relief from traditional depression therapies.

How Is the Trial Designed?

Group I: Focused Ultrasound Neuromodulation Experimental Treatment 1 Intervention

Participants will receive two sessions of Magnetic Resonance-guided focused ultrasound neuromodulation targeting regions within the cortical-striatal-thalamic circuit (CSTC) implicated in treatment-resistant depression. Treatments will be spaced four weeks apart. All participants will receive the same intervention and will be followed for 4 weeks post-treatment to evaluate clinical outcomes, adverse events, and depression symptoms.

Who Is Running the Clinical Trial?

Sunnybrook Health Sciences Centre

Lead Sponsor

Trials

693

Recruited

1,569,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07094789

Focused Ultrasound Neuromodulation in Patients With ... The goal of this clinical trial is to evaluate the safety and initial effectiveness of Magnetic Resonance-guided focused ultrasound neuromodulation using the ...

2. fusfoundation.org fusfoundation.org/diseases-and-conditions/depression/

Depression A clinical trial in Ontario, Canada is using the next generation dome helmet to treat patients with treatment resistant depression. A ...

3. withpower.com withpower.com/trial/phase-depressive-disorder-treatment-resistant-6-2025-ccd7f

Focused Ultrasound Neuromodulation for Depression The goal of this clinical trial is to evaluate the safety and initial effectiveness of Magnetic Resonance-guided focused ultrasound neuromodulation using ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT07094789?aggFilters=status%3Arec

Study Details | Focused Ultrasound Neuromodulation in ... An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during a clinical study or within a certain amount of ...

5. fusfoundation.org fusfoundation.org/posts/clinical-trial-results-focused-ultrasound-neuromodulation-improves-mood-anxiety-and-trauma-related-disorders/

Clinical Trial Results The researchers successfully targeted the left amygdala, which is known to be hyperactive in mood and anxiety disorders. The results from the ...