Actively Recruiting
Assessment of Safety and Feasibility of Focused Ultrasound Next Generation Dome Helmet (NGDH) to Perform Neuromodulation in Patients With Treatment-Resistant Depression
Led by Sunnybrook Health Sciences Centre · Updated on 2025-08-11
20
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and initial effectiveness of Magnetic Resonance-guided focused ultrasound neuromodulation using the Next Generation Dome Helmet (NGDH) device in adults with treatment-resistant depression. This prospective, single-arm, non-randomized study aims to better understand this device's potential in targeting brain circuits involved in depression when other treatments have not worked. The study will enroll 20 participants diagnosed with major depressive disorder who have not responded to standard treatments. Participants will receive two sessions of focused ultrasound treatment targeting regions within the cortical-striatal-thalamic circuit (CSTC), spaced four weeks apart. Each session involves precise sonications guided by MRI, safety monitoring during treatment, and imaging assessments afterward. Follow-up visits occur 24 hours, 2 weeks, and 4 weeks after each treatment to evaluate clinical effects and safety. All participants receive the same intervention without a comparison group. During the study, participants will have clinical scales and imaging assessments to monitor depression symptoms and safety. The primary outcome measures include safety and feasibility assessments at multiple time points before and after treatments. Secondary outcomes focus on changes in depressive symptoms measured by the Hamilton Depression Rating Scale (HAMD-17). The total participation time includes treatment sessions and follow-ups extending up to four weeks after the second treatment session.
CONDITIONS
Brief Title
Focused Ultrasound Neuromodulation in Patients With Treatment-Resistant Depression
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ability to provide informed consent
- Age between 18 and 65 years
- Diagnosis of major depressive disorder (MDD) according to DSM-5 criteria
- Total score greater than 20 on the Hamilton Depression Rating Scale (HAMD-17)
- On stable psychiatric medications for at least 30 days before enrollment
- Previous trial of at least two first-line antidepressant agents at adequate dose and duration
- Previous trial of cognitive behavioral therapy (CBT) or psychotherapy for MDD for at least 6 weeks
You will not qualify if you...
- Pregnant or planning to become pregnant during the study
- Diagnosis of moderate or greater substance use disorder (except cannabis or nicotine)
- Known active seizure disorder or significant head injury with lesion seen on imaging
- Unstable medical illness
- Not eligible for 3-Tesla MRI (e.g., MRI-incompatible pacemaker)
- Unable to reliably attend required appointments
- Severe claustrophobia preventing MRI procedures
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 8 weeks
Participants receive two sessions of Magnetic Resonance-guided focused ultrasound neuromodulation targeting brain regions implicated in treatment-resistant depression. Treatments are spaced four weeks apart and include pre-treatment assessments, precise sonications, safety monitoring, and post-treatment imaging.
2 treatment sessions with assessments 24 hours and 2 weeks after each session
Duration - 4 weeks
Participants are monitored for clinical outcomes, adverse events, and changes in depression symptoms for 4 weeks following the second treatment session.
Visits at 2 and 4 weeks after the second treatment
Trial Site Locations
Total: 1 location
1
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
Actively Recruiting
Research Team
N
Nir Lipsman, MD, PhD, FRCSC
A
Anusha Baskaran, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here