Focused Ultrasound Neuromodulation in Patients With Treatment-Resistant Depression
Key facts
- Where
- Toronto, CanadaSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Source: NCT07094789, who can take part
Where in Canada
- Sunnybrook Health Sciences CentreToronto, CanadaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Sunnybrook Health Sciences Centre
- Trial code
- NCT07094789
- Record updated
- 11 August 2025
- Original description
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.Read full original descriptionShow less
Assessment of Safety and Feasibility of Focused Ultrasound Next Generation Dome Helmet (NGDH) to Perform Neuromodulation in Patients With Treatment-Resistant Depression
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.
Inclusion: 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.
Exclusion: 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; 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.