Actively Recruiting
Focused Ultrasound Neuromodulation in Patients With Treatment-Resistant Depression
Led by Sunnybrook Health Sciences Centre · Updated on 2025-08-11
20
Participants Needed
1
Research Sites
107 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Focused Ultrasound Neuromodulation in Patients With Treatment-Resistant Depression
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to provide informed consent
- Between 18 and 65 years old
- Diagnosed with major depressive disorder (MDD) according to DSM-5 criteria
- Total score over 20 on the Hamilton Depression Rating Scale (HAMD-17)
- On stable psychiatric medications for at least 30 days before enrollment
- Documented previous trial of at least two first-line antidepressant agents at adequate dose and duration, confirmed by two psychiatrists
- Documented previous trial of cognitive behavioral therapy (CBT) or psychotherapy for MDD lasting at least 6 weeks
You will not qualify if you...
- Pregnant or intending to become pregnant during the study period
- Diagnosis of moderate or greater substance use disorder (excluding cannabis or nicotine) or if substance use is primary focus of treatment
- Known active seizure disorder or significant head injury with imaging-verified lesion
- Unstable medical illness
- Not eligible for 3-Tesla MRI (e.g., MRI-incompatible pacemaker)
- Unable to reliably attend required screening, treatment, or follow-up appointments
- Severe claustrophobia preventing completion of MRI procedures
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
A
Anusha Baskaran, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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