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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.
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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Focused Ultrasound Neuromodulation | Experimental | Focused Ultrasound Neuromodulation: Participants will receive two sessions of Magnetic Resonance-guided focused ultrasound neuromodulation targeting regions within the cortical-striatal-thalamic circuit (CSTC) implicated in treatment-resistant depression. Treatments will be spaced four weeks apart. All participants will receive the same intervention and will be followed for 4 weeks post-treatment to evaluate clinical outcomes, adverse events, and depression symptoms. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Next Generation Dome Helmet (NGDH) | Device | Participants 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Assessments will be conducted at the baseline visit; on the day of each of the two treatments; 24 hours after each treatment; at 1 and 2 weeks after each treatment; and 4 weeks after the second treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Inclusion Criteria:
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nir Lipsman, MD, PHD, FRCSC, FAANS | Contact | (416)-480-6954 | Nir.Lipsman@sunnybrook.ca | |
| Anusha Baskaran, PhD | Contact | 416-480-6100 | 61650 | anusha.baskaran@sunnybrook.ca |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sunnybrook Health Sciences Centre | Recruiting | Toronto | Ontario | M4N 3M5 | Canada |
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| Assessments will be conducted at baseline; 24 hours after each treatment; at 1 and 2 weeks after each treatment; and 4 weeks after the second treatment. |
| 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. | Assessments will be conducted at baseline; 24 hours after each treatment; at 1 and 2 weeks after each treatment; and 4 weeks after the second treatment. |
| 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. | Assessments will be conducted at baseline; 24 hours after each treatment; at 1 and 2 weeks after each treatment; and 4 weeks after the second treatment. |
| 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. | Assessments will be conducted at baseline; 24 hours after each treatment; at 1 and 2 weeks after each treatment; and 4 weeks after the second treatment. |
| Change in Anxiety Symptoms as Measured by the Generalized Anxiety Disorder-7 (GAD-7) | The GAD-7 is a 7-item self-report questionnaire used to assess generalized anxiety symptoms. Total scores range from 0 to 21, with higher scores indicating greater anxiety severity. Scores of 5, 10, and 15 represent commonly used thresholds for mild, moderate, and severe anxiety, respectively. Change from baseline will be evaluated at each assessment time point. | Assessments will be conducted at baseline; 24 hours after each treatment; at 1 and 2 weeks after each treatment; and 4 weeks after the second treatment. |
| Change in Patient-Reported Outcomes Using Likert Scales (1-9) | A brief set of 1-9 Likert scales will be used to assess patient-reported symptoms and subjective experiences. Scores range from 1 to 9, with higher scores indicating greater symptom severity or impact. Change from baseline will be evaluated at each assessment time point. | Assessments will be conducted at baseline; 24 hours after each treatment; at 1 and 2 weeks after each treatment; and 4 weeks after the second treatment. |
| Change in Depressive Symptoms as Measured by the 17-Item Hamilton Depression Rating Scale (HAMD-17) | The HAMD-17 is a clinician-administered scale used to assess the severity of depressive symptoms. Total scores range from 0 to 52, with higher scores indicating greater depressive symptom severity. Change from baseline will be evaluated at each assessment time point. | Assessments will be conducted at baseline; 24 hours after each treatment; at 1 and 2 weeks after each treatment; and 4 weeks after the second treatment. |
| ID | Term |
|---|---|
| D009771 | Obsessive-Compulsive Disorder |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D001523 | Mental Disorders |
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