NCT07704632 Safety and Feasibility of FUS Next Generation Dome Helmet (NGDH) to Perform Neuromodulation in Patients With Treatment Refractory Obsessive Compulsive Disorder (OCD)
| NCT ID | NCT07704632 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Sunnybrook Health Sciences Centre |
| Condition | OCD |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2025-09-23 |
| Primary Completion | 2027-09 |
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 2025-09-23 with a primary completion date of 2027-09.
⚠ 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
This study evaluates the safety, feasibility, and preliminary efficacy of focused ultrasound (FUS) neuromodulation delivered using the Next Generation Dome Helmet (NGDH) in participants with treatment-refractory obsessive-compulsive disorder (OCD). Participants will undergo two study sessions, four weeks apart, involving active FUS neuromodulation targeting nodes of the cortico-striato-thalamo-cortical (CTSC) circuit. Outcomes include adverse events, changes in OCD symptom severity, and quality of life.
Eligibility Criteria
Inclusion Criteria: 1. Must be deemed to have the capacity to provide informed consent. 2. Age 18 to 85 years. 3. Diagnosis of obsessive-compulsive disorder according to DSM-5 criteria. 4. Yale-Brown Obsessive Compulsive Scale total score greater than 22. 5. If taking psychiatric medications, must be on a stable regimen for at least 30 days before enrollment. Psychiatric medications will be continued throughout the study. 6. Previous trial of at least two first-line antidepressant agents at an adequate dose and duration, as assessed by two psychiatrists. 7. Previous trial of cognitive behavioural therapy or psychotherapy for OCD for at least 6 weeks. Exclusion Criteria: 1. Pregnant or intending to become pregnant during the study. 2. Substance use disorder, other than cannabis or nicotine use disorder, of moderate severity or greater, or where the substance is the primary substance of concern, according to DSM-5 criteria. 3. Known active seizure disorder or significant head injury with an imaging-confirmed lesion. 4. Unstable medical illness. 5. Not eligible for 3-Tesla MRI, such as due to an MRI-incompatible pacemaker or other implanted device. 6. Unable to reliably attend the required screening, treatment, and follow-up visits. 7. Severe claustrophobia that would prevent MRI scanning. 8. History of a bleeding disorder or coagulopathy. 9. Anticoagulant therapy or use of medications known to increase the risk of hemorrhage within the required washout period before treatment, including: * Antiplatelet agents or vitamin K antagonist anticoagulants within 7 days of treatment * Non-vitamin K oral anticoagulants within 72 hours of treatment * Heparin-derived compounds within 48 hours of treatment
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07704632 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 85 Years, studying OCD. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07704632 currently recruiting?
Yes, NCT07704632 is actively recruiting participants. Contact the research team at Nir.Lipsman@sunnybrook.ca for enrollment information.
Where is the NCT07704632 trial being conducted?
This trial is being conducted at Toronto, Canada.
Who is sponsoring the NCT07704632 clinical trial?
NCT07704632 is sponsored by Sunnybrook Health Sciences Centre. The trial plans to enroll 20 participants.