Overview
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.
Description
This study is designed as a prospective, single arm, nonrandomized study aiming to evaluate safety and tolerability of transcranial focused ultrasound neuromodulation targeting CTSC circuit nodes (including VC/VS, STN, ACC, OFC, and caudate nucleus).
Twenty participants with treatment-refractory OCD will be enrolled. Each participant will receive two treatment sessions (4 weeks apart)
Eligibility
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Pregnant or intending to become pregnant during the study.
- 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.
- 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.
- History of a bleeding disorder or coagulopathy.
- 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
