Focused Ultrasound Neuromodulation in Patients With Treatment-Resistant Depression
Recruiting · NCT07094789 · Interventional (participants receive a specific treatment) · Lead sponsor: Sunnybrook Health Sciences Centre
View the official record on ClinicalTrials.gov →Interventions studied
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.
Who can take part
Inclusion criteria
- 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 criteria
- Pregnant or intending to become pregnant during the study period.
- 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.
- 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.
Where it is running
1 location listed.
- Sunnybrook Health Sciences Centre - Toronto, Ontario, Canada