Safety and Feasibility of FUS Next Generation Dome Helmet (NGDH) to Perform Neuromodulation in Patients With Treatment Refractory Obsessive Compulsive Disorder (OCD)

Who can take part

• Must be deemed to have the capacity to provide informed consent
• Age 18 to 85 years
• Diagnosis of obsessive-compulsive disorder according to DSM-5 criteria
• Yale-Brown Obsessive Compulsive Scale total score greater than 22
• 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
• Previous trial of at least two first-line antidepressant agents at an adequate dose and duration, as assessed by two psychiatrists
• Previous trial of cognitive behavioural therapy or psychotherapy for OCD for at least 6 weeks

Who cannot take part

• 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
• 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
• Known active seizure disorder or significant head injury with an imaging-confirmed lesion
• Unstable medical illness
• History of a bleeding disorder or coagulopathy
• Pregnant or intending to become pregnant during the study
• Not eligible for 3-Tesla MRI, such as due to an MRI-incompatible pacemaker or other implanted device
• Unable to reliably attend the required screening, treatment, and follow-up visits
• Severe claustrophobia that would prevent MRI scanning