RecruitingNot ApplicableNCT07094789

Focused Ultrasound Neuromodulation in Patients With Treatment-Resistant Depression

Assessment of Safety and Feasibility of Focused Ultrasound Next Generation Dome Helmet (NGDH) to Perform Neuromodulation in Patients With Treatment-Resistant Depression


Sponsor

Sunnybrook Health Sciences Centre

Enrollment

20 participants

Start Date

Jul 11, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this clinical trial is to evaluate the safety and initial effectiveness of Magnetic Resonance-guided focused ultrasound neuromodulation using the Next Generation Dome Helmet (NGDH) device in patients with treatment-resistant depression. This is a prospective, single-arm, non-randomized study. Participants will: * Undergo two focused ultrasound treatment sessions targeting nodes of the cortical-striatal-thalamic circuit (CSTC) , spaced four weeks apart. * Return for follow-up visits at 24 hours, 2 weeks, and 4 weeks after each treatment session, during which clinical scales and imaging assessments will be conducted to monitor safety and clinical effects.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is testing focused ultrasound (FUS) neuromodulation — a non-invasive technique that uses sound waves to gently stimulate specific brain areas — in people with treatment-resistant depression (depression that has not improved after trying multiple standard treatments). The goal is to see whether this brain-stimulation approach can safely reduce depression symptoms. **You may be eligible if...** - You are between 18 and 65 years old - You have been diagnosed with major depressive disorder (MDD) - Your depression score is above 20 on the standard Hamilton Depression Rating Scale - You have tried at least two different antidepressant medications at appropriate doses without sufficient improvement - You have also tried at least 6 weeks of cognitive behavioral therapy or psychotherapy - You have been on a stable medication regimen for at least 30 days **You may NOT be eligible if...** - You are pregnant or planning to become pregnant during the study - You have a moderate or severe substance use disorder (alcohol or drugs) - You have an active seizure disorder or a significant brain injury - You have an unstable medical illness - You cannot have an MRI (e.g., due to a pacemaker) - You have severe claustrophobia that prevents MRI Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICENext Generation Dome Helmet (NGDH)

Participants will receive two sessions of Magnetic Resonance-guided focused ultrasound neuromodulation, spaced four weeks apart, using the Next Generation Dome Helmet device. Treatments will target regions within the CSTC circuit identified by advanced MRI scans. Each session will include pre-treatment assessments, precise sonications of deep brain structures, real-time safety monitoring, and post-treatment imaging.


Locations(1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

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NCT07094789


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