NCT07094789Recruiting
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
Source: ClinicalTrials.gov · Last updated 11 Aug 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 23 Jul 2025
- Start date
- Jul 2025
- Primary completion date
- Aug 2027
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Diseases
- Depression
- NCT number
- NCT07094789
What you commit to
- Study type: Interventional
- Planned participants: 20
- From Jul 2025 to the primary completion date, Aug 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
- Known active seizure disorder, significant head injury with an imaging-verified lesion
- Unstable medical illness.
Other
- Pregnant or intending to become pregnant during the study period.
- Not eligible for 3-Tesla MRI (i.e. MRI-incompatible pacemaker)
- Inability to reliably attend required screening, treatment, or follow-up appointments.
- Severe claustrophobia, as identified by the participant, that would prevent completion of MRI procedures.
Who the study is looking for
- Deemed to have the capacity to provide informed consent.
- Aged between 18 and 65 years.
- Diagnosis of major depressive disorder (MDD) according to DSM-5 criteria.
- Total score \>20 on the Hamilton Depression Rating Scale (HAMD-17).
- On a stable regimen of psychiatric medications for at least 30 days prior to enrollment.
- Documented previous trial of at least two first-line antidepressant agents at adequate dose and duration, as assessed by two psychiatrists.
- Documented previous trial of cognitive behavioral therapy (CBT) or psychotherapy for MDD, sustained for at least 6 weeks.
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sunnybrook Health Sciences Centre Coordinator of this site? Confirm its status | Toronto | Canada | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.