Obsessive-Compulsive Disorder, Obsessive-Compulsive Disorder (OCD), OCD
Conditions
Keywords
Focused ultrasound (FUS), MRgFUS, FUS Neuromodulation
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.
Detailed 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)
Interventions
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.
Sponsors
Sunnybrook Health Sciences Centre
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and Feasibility of FUS Neuromodulation in Participants With Treatment-Refractory Obsessive-Compulsive Disorder | 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. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Obsessive-Compulsive Symptom Severity Measured by the Yale-Brown Obsessive Compulsive Scale (Y-BOCS) | 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. | 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) | 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. | 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) | 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. | 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) | 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. | 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. |
| Change in Anxiety Symptoms as Measured by the Generalized Anxiety Disorder-7 (GAD-7) | 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. | 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. |
| Change in Patient-Reported Outcomes Using Likert Scales (1-9) | 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. | 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. |
| Change in Depressive Symptoms as Measured by the 17-Item Hamilton Depression Rating Scale (HAMD-17) | 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. | 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. |
Countries
Canada
Contacts
CONTACTNir Lipsman, MD, PHD, FRCSC, FAANS
CONTACTAnusha Baskaran, PhD
Outcome results
None listed