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).
Men and women ≥18 and ≤65 years of age, inclusive.
Patients who are competent and willing to give consent and able to attend study visits, as determined by both study Psychiatrist and the surgeon.
Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) diagnosis of Bipolar Disorder, Type 1 or Type 2.
A minimum score of 20 on the Hamilton Depression Rating Scale (HAMD) when depressed (at least 2 weeks of major depression at the time the HAMD is conducted).
None
Single group
ExAblate Neuro 4000
DeviceExAblate 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.
Safety 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.
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.
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.
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.
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.
Click on the lead sponsor to view all of their trials.
