NCT07094789 Focused Ultrasound Neuromodulation in Patients With Treatment-Resistant Depression
| NCT ID | NCT07094789 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Sunnybrook Health Sciences Centre |
| Condition | Treatment-Resistant Depression |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2025-07-11 |
| Primary Completion | 2027-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 20 participants in total. It began in 2025-07-11 with a primary completion date of 2027-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: 1. Deemed to have the capacity to provide informed consent. 2. Aged between 18 and 65 years. 3. Diagnosis of major depressive disorder (MDD) according to DSM-5 criteria. 4. Total score \>20 on the Hamilton Depression Rating Scale (HAMD-17). 5. On a stable regimen of psychiatric medications for at least 30 days prior to enrollment. 6. Documented previous trial of at least two first-line antidepressant agents at adequate dose and duration, as assessed by two psychiatrists. 7. Documented previous trial of cognitive behavioral therapy (CBT) or psychotherapy for MDD, sustained for at least 6 weeks. Exclusion Criteria: 1. Pregnant or intending to become pregnant during the study period. 2. 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. 3. Known active seizure disorder, significant head injury with an imaging-verified lesion 4. Unstable medical illness. 5. Not eligible for 3-Tesla MRI (i.e. MRI-incompatible pacemaker) 6. Inability to reliably attend required screening, treatment, or follow-up appointments. 7. Severe claustrophobia, as identified by the participant, that would prevent completion of MRI procedures.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07094789 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Treatment-Resistant Depression. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07094789 currently recruiting?
Yes, NCT07094789 is actively recruiting participants. Contact the research team at Nir.Lipsman@sunnybrook.ca for enrollment information.
Where is the NCT07094789 trial being conducted?
This trial is being conducted at Toronto, Canada.
Who is sponsoring the NCT07094789 clinical trial?
NCT07094789 is sponsored by Sunnybrook Health Sciences Centre. The trial plans to enroll 20 participants.
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