The goal of this clinical trial is to evaluate the safety and initial effectiveness of MR-guided focused ultrasound (MRgFUS) bilateral capsulotomy in patients with treatment-resistant bipolar depression (TRBD).
This study is a prospective, single arm and nonrandomized phase l study. Participants will: * Undergo MRgFUS capsulotomy targeting the anterior limb of the internal capsule. * Be assessed before and after treatment for adverse events, symptom changes, and quality of life. * Complete a battery of clinical rating scales including the Hamilton Depression Rating Scale (HAMD), Beck Depression Inventory (BDI), Beck Anxiety Inventory (BAI), Young Mania Rating Scale (YMRS), Yale-Brown Obsessive Compulsive Scale (YBOCS), and the Columbia-Suicide Severity Rating Scale (C-SSRS), along with the Quality of Life Enjoyment and Satisfaction Questionnaire (QLESQ). A total of 10 participants, all patients at Sunnybrook Hospital, are expected to enroll in the study. Each participant will be involved for approximately 26 months, including a 2-month pre-treatment period and 24 months of follow-up. The full study duration is estimated at 3 years, with primary results anticipated within 2 to 3 years.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
ExAblate Neuro 4000 is an MR-guided focused ultrasound (MRgFUS) device used to perform noninvasive thermal ablation of targeted brain tissue. In this study, ExAblate Neuro 4000 will be used to ablate the anterior limb of the internal capsule (capsulotomy) in patients with treatment-resistant bipolar depression (TRBD). The procedure is conducted under real-time MRI guidance and thermometry to assess safety and initial effectiveness in improving clinical symptoms and quality of life.
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
RECRUITINGSafety of Magnetic Resonance-guided Focused Ultrasound for patients with Treatment-Resistant Bipolar Disorder
Assessment of the frequency and severity of adverse events associated with ExAblate Transcranial Magnetic Resonance-guided Focused Ultrasound (MRgFUS) in patients with Treatment-Resistant Bipolar Disorder (TRBD). Adverse events, including procedure-related complications and neurological events, will be documented and assessed.
Time frame: From the treatment day visit through the 24-month post-treatment time points.
Clinical Efficacy - Change in Depressive Symptoms Measured by the Hamilton Depression Rating Scale (HAMD-17)
Evaluate the effectiveness of MR-guided Focused Ultrasound (MRgFUS) in reducing symptoms of bipolar depression. Clinical efficacy will be assessed by the change in scores on the Hamilton Depression Rating Scale - 17 item version (HAMD-17) from baseline through follow-up visits. The HAMD-17 is a clinician-administered scale that assesses the severity of depressive symptoms. Total scores range from 0 to 52, with higher scores indicating more severe depression.
Time frame: Assessed at baseline, 1 month, 3 months, 6 months, 12 months, 18 months and 24 months post-treatment.
Change in Depressive Symptom Severity Measured by the Beck Depression Inventory (BDI)
Evaluate the effectiveness of MR-guided Focused Ultrasound (MRgFUS) in reducing depressive symptom severity using the Beck Depression Inventory, a validated patient-reported scale. Assessments will occur at baseline and at specified follow-up visits. The BDI consists of 21 items assessing symptoms of depression experienced over the past two weeks. Total scores range from 0 to 63, with higher scores indicating more severe depressive symptoms.
Time frame: Assessed at baseline, 1 month, 3 months, 6 months, 12 months, 18 months and 24 months post-treatment.
Clinical Efficacy - Change in Anxiety Symptoms measured by Beck Anxiety Inventory (BAI)
Evaluate the effectiveness of MR-guided Focused Ultrasound (MRgFUS) in reducing anxiety symptom severity using the Beck Anxiety Inventory (BAI), a validated patient-reported scale. Assessments will occur at baseline and at specified follow-up visits. The BAI consists of 21 items measuring common symptoms of anxiety experienced over the past week. Each item is rated on a scale from 0 (not at all) to 3 (severely). Total scores range from 0 to 63, with higher scores indicating more severe anxiety symptoms.
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Time frame: Baseline, 1 month, 3 months, 6 months, 12 months, 18 months, and 24 months post-treatment.
Clinical Efficacy - Change in Manic Symptoms measured by Young Mania Rating Scale (YMRS)
Evaluate the effectiveness of MR-guided Focused Ultrasound (MRgFUS) in reducing manic symptom severity using the Young Mania Rating Scale (YMRS), a validated clinician-administered rating scale. Assessments will occur at baseline and at specified follow-up visits. The YMRS consists of 11 items used to assess the severity of manic symptoms. Total scores range from 0 to 60, with higher scores indicating more severe mania.
Time frame: Baseline, 1 month, 3 months, 6 months, 12 months, 18 months, and 24 months post-treatment.
Clinical Efficacy - Change in Obsessive-Compulsive Symptoms measured by Yale-Brown Obsessive Compulsive Scale (YBOCS)
Evaluate the effectiveness of MR-guided Focused Ultrasound (MRgFUS) in reducing obsessive-compulsive symptom severity using the Yale-Brown Obsessive Compulsive Scale (Y-BOCS). Assessments will occur at baseline and at specified follow-up visits. The Y-BOCS is a clinician-administered instrument that assesses the severity of obsessive and compulsive symptoms. Total scores range from 0 to 40, with higher scores indicating more severe obsessive-compulsive symptoms.
Time frame: Baseline, 1 month, 3 months, 6 months, 12 months, 18 months, and 24 months post-treatment
Change in Suicidal Ideation and Behavior measured by Columbia-Suicide Severity Rating Scale (C-SSRS)
Evaluate the effectiveness of MR-guided Focused Ultrasound (MRgFUS) in reducing suicidal ideation and behavior using the Columbia-Suicide Severity Rating Scale (C-SSRS). Assessments will occur at baseline and at specified follow-up visits. The C-SSRS is a clinician-administered tool that categorizes the severity and intensity of suicidal ideation and records the presence or absence of suicidal behavior. Suicidal ideation is rated on a scale from 1 (wish to be dead) to 5 (active suicidal ideation with specific plan and intent). Suicidal behavior is assessed based on the occurrence of actual, aborted, or interrupted suicide attempts, and preparatory behaviors. Higher scores or presence of behaviors indicate greater severity.
Time frame: Baseline, 1 month, 3 months, 6 months, 12 months, 18 months, and 24 months post-treatment.