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.
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.
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.
Single group
Next Generation Dome Helmet (NGDH)
DeviceParticipants will receive two sessions of Magnetic Resonance-guided focused ultrasound neuromodulation, spaced four weeks apart, using the Next Generation Dome Helmet device. Treatments will target regions within the CSTC circuit identified by advanced MRI scans. Each session will include pre-treatment assessments, precise sonications of deep brain structures, real-time safety monitoring, and post-treatment imaging.
Safety and Feasibility of FUS Neuromodulation in Participants With Treatment-Refractory Obsessive-Compulsive Disorder
Assessment of the frequency and severity of adverse events associated with focused ultrasound neuromodulation in patients with treatment-refractory obsessive-compulsive disorder. Adverse events, including procedure-related complications and neurological events, will be documented and assessed.
Change in Obsessive-Compulsive Symptom Severity Measured by the Yale-Brown Obsessive Compulsive Scale (Y-BOCS)
Evaluate the effectiveness of FUS Neuromodulation in reducing obsessive-compulsive symptom severity using the Yale-Brown Obsessive Compulsive Scale (Y-BOCS). The Y-BOCS is a clinician-administered scale assessing the severity of obsessive-compulsive symptoms. Total scores range from 0 to 40, with higher scores indicating greater symptom severity (0-7 subclinical, 8-15 mild, 16-23 moderate, 24-31 severe, and 32-40 extreme).
Change in Quality of Life as Measured by the Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q)
Quality of life will be assessed using the Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q). The Q-LES-Q is a self-report measure assessing quality of life across multiple domains. Total scores are typically transformed into a percentage of the maximum possible score, with higher percentages indicating greater life satisfaction and functioning. Change from baseline will be evaluated at each assessment time point.
Change in Obsessive-Compulsive Symptoms as Measured by the Obsessive Compulsive Inventory (OCI)
The Obsessive Compulsive Inventory is a self-report measure used to assess obsessive-compulsive symptoms. Higher scores indicate greater symptom severity. Change from baseline will be evaluated at each assessment time point.
Change in Anxiety Symptoms as Measured by the Beck Anxiety Inventory (BAI)
The Beck Anxiety Inventory (BAI) is a 21-item self-report scale assessing the severity of anxiety symptoms. Total scores range from 0 to 63, with higher scores indicating greater anxiety severity (0-7 minimal, 8-15 mild, 16-25 moderate, and 26-63 severe anxiety). Change from baseline will be evaluated at each assessment time point.
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